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Clinical trials are organized into three stages: phase I, phase II, and phase Ill. Each phase attempts to address different and increasingly complex issues concerning the success of the new treatment. Some drugs are tested in trials that are a combination of two phases. Usually this is done if some knowledge of the new treatments effect in humans is already known so that its development and testing can be expedited.
There may be clinical trials in which you can participate locally on an outpatient basis, but many require travel and inpatient stays.

Phase I clinical trials
The primary purpose of a phase I clinical trial is to measure the safety and toxicity of different doses of a new substance in the human body. Some phase I studies may also assess tumor response, therapeutic effectiveness, the amount of drug that accumulates in the body, and a substance's general behavior (pharmacokinetics) in the body.
Phase I trials are preceded by animal studies that measure toxicity, so an estimated safe human dose is already known. Rigorous controls are enforced to be sure that no patient suffers adverse effects. For example, blood or urine values of certain body substances may be measured several times a day to ensure that the liver and kidneys are not compromised. Doses that are found to be unacceptably toxic are lowered.
Phase I trials usually enroll just a few patients, perhaps ten to thirty. Often these patients have a variety of different cancers. Sometimes one cohort of patients will receive only a low dose of the drug, and a different group will receive higher doses; but in other studies, the same patients who initially receive a low dose may be given a higher dose later if toxicity is not too profound.

The advantages of a phase I trial are:
 You may receive a treatment that may be better than anything else currently approved by the FDA years before it becomes available to the general public.
 If this drug is already in use for other illnesses, its toxic effects might not be completely unknown.
 Candidate substances for cancer treatment are not approved for phase I trials unless the substance has shown reasonably acceptable toxicity, as well as activity against cancer, in cultured tumor cell lines and in animal studies. Of every five thousand substances tested in animals, only five enter phase I trials.
 Doses found to cause unacceptable toxicity are lowered.
The disadvantages of a phase I trial are:
• For every 100 drugs tested in phase I trials, only 70 will prove successful or safe enough to carry forward into phase II trials.
• Because phase I trials are chiefly concerned with discovering dose-limiting toxicity, they are brief compared to phase II and III trials. You may receive too few doses of the test substance to destroy all of your cancerous cells.
• Phase I trials usually test one substance alone, yet experience has shown that, at least for the chemotherapeutic agents commonly used today, combined drug regimens often are more effective against most cancers than single-drug regimens.
• The substance, although it may be an approved drug for other illnesses or even for other cancers, most likely has never before been used in humans for your illness. Although it has been tested in cultured tumor cell lines and in animals implanted with tumors, it may not be effective against your tumor, or it may be no better than existing treatments.
• The substance, although it may be an approved drug for other illnesses or even for other cancers, may be administered to you at a much higher, more toxic dose.
• The dosage will be varied among those enrolled, thus its effects on your tumor may not be directly comparable to the effects on the tumors of others enrolled in the trial ... and patients do talk among themselves.
• The use of patients with different tumor types makes it difficult for you to compare your progress to that of other patients.
• Toxicity may cause substantial discomfort, illness, or permanent damage, in spite of the safeguards designed to prevent damage.
• Often phase I trials are run by one principal investigator at one institution. You may have to travel to participate in a phase I trial.
Here are the titles of a few phase I trials for lung cancer selected from the NCI clinical trials database. These trials illustrate the broad variety of cancers being studied simultaneously in phase I trials. Note that the titles state the phase number and, at this phase, make no reference to randomization or blinding. Don't be distracted by the overly technical verbiage in these titles. You'll become more familiar with the terminology as you read more about your illness:
• Phase If II study of Lepirudin in patients with recurrent or extensive stage small cell lung cancer
• Phase I study of Bryostatin 1 in patients with advanced cancer
• Phase I pilot study of vaccine therapy with tumor-specific mutated ras pep tides in advanced cancer

Phase II clinical trials
Phase II trials measure the effectiveness of new treatments against cancer after phase I trials have demonstrated the maximum safe dose. Some phase II trials also attempt to measure how best to deliver the drug to the tumor--orally, by infusion, and so onand how often the dose should be given.
Phase II trials enroll many more patients than phase I trials, perhaps fifteen to eighty, so that the substance will receive a more thorough test and the statistics collected will be more meaningful.
Sometimes, but not always, phase II clinical trials are divided into arms, with one arm getting one version of the experimental treatment and a second arm getting another-perhaps the same experimental agent combined with an established, FDA approved cancer-killing drug; or delivered by another route; or on a different dose schedule.
Because some phase I trials seek preliminary evidence of efficacy against disease, 1 a clearer idea might exist regarding what cancers will benefit most from this treatment when it's used in a phase II trial. Nonetheless, the researchers designing the trial usually determine the types of cancers that will be addressed in a phase II trial. Sometimes parallel phase II trials for different cancers will be designed and funded.
Phase II trials take more time than phase I trials because, unlike phase I trials, more of the new agent is administered for a longer time in an attempt to cause tumor regression.

The advantages of a phase II trial are:
• Candidate substances for cancer treatment are not approved for phase II trials unless phase I trials have shown that the substance is safe at a given dose and, in some trials, that the substance has some activity against cancer in humans.
 You'll be receiving a treatment that may well be better than anything else currently approved by the FDA several years before it becomes available to the general public.
 Only doses of acceptable toxicity, determined during phase I testing, are utilized.
 Randomizing and blinding usually are not used in phase II trials. Therefore, you are assured of receiving the experimental treatment.

The disadvantages of a phase II trial are:
• More than half of the drugs used in phase II trials will be found ineffective against cancer or too problematic for use. Of the original 100 drugs that entered phase I trials, of which 70 survived to pass to phase II, only 33 will survive phase II testing.
• The substance, although it may be an approved drug for other illnesses or even for other cancers, may not prove to be better than existing treatments for your illness.
• Although its toxicity was determined in the phase I trial of this substance, the substance is still an evolving treatment with the potential for unexpected side effects.
• More of your time will be needed for a phase II trial than for a phase I trial.
• You might have to travel to participate in a phase II trial.
Here are a few examples of phase II trials for lung cancer selected from the NCl clinical trials database. Note the occasional use of randomization and that fewer cancer types are eligible:
• Phase II study of intensive chemotherapy with peripheral blood stem cell support in patients with small cell lung cancer
• Phase II randomized study of autologous tumor cell vaccine in patients with advanced cancer
• Phase II study of vasopressin receptor type I-A antagonist SR49059 in patients with refractory small cell lung cancer
Phase III clinical trials
Phase III clinical trials test a new substance's efficacy compared to existing standard treatments.
Phase III trials are much larger than phase II trials and are almost always multi-center trials; that is, trials run in many sites simultaneously They run for years, including multiyear follow-up of the patient's cancer status and overall health.
The large number of patients in a phase III trial tends to flatten any aberrant statistics that result from patient differences that would lessen the usefulness of statistical data collected in a smaller trial. For this reason, patients in a phase III randomized trial can be of various ages and both sexes, for example, as long as they're all stage III NSCLC patients or all SCLC patients with limited disease, and so on.
Phase III trials are almost always randomized (case-control studies are not), but are not always blinded or double-blinded. When blinding is used, patients might discover which treatment they're receiving based on side effects, comparisons in conversations with other patients, or other overt or subtle phenomena.
The advantages of a phase III trial are:
• A substance that has survived the scrutiny of phases I and II is very likely to be better than current treatments: either more efficacious, or equally effective but less toxic.
• You'll be receiving a treatment that may be better than anything else currently approved by the FDA a year or two before it becomes available to the general public.
• If, during the trial, a new treatment shows itself to be profoundly superior to existing treatment, those receiving the existing treatment are switched to the arm of the study utilizing the new substance.
• If a new treatment shows itself to be clearly or dangerously inferior to existing treatment, those receiving the new treatment are switched to the standard treatment regimen.
The disadvantages of a phase III trial are:
• Of the 33 drugs that survived phase II testing, only about 25 will be found effective in phase III trials.
• Randomizing and blinding may not appeal to those who are determined to receive only the new treatment, not the contrasting current treatment.
• The new substance may prove to be just as effective as, but no better than, the existing treatment.
Here are a few examples of phase III trials for lung cancer selected from the NCI clinical trials database:
• Phase III randomized study of Matrix Metalloprotease Inhibitor AG3340 in combination with paclitaxel and carboplatin in patients with recurrent or metastatic non-small cell lung cancer
• Phase III randomized study of Gadolinium Texaphyrin as a radio sensitizer in patients with brain metastases receiving whole brain radiotherapy

Which phase is best?
This chapter cannot offer you absolute advice about which type of clinical trial is best for you. Only you and your treatment team should make this decision. Several aspects can be considered, though:
• A phase III trial that offers randomization to either standard therapy or a new therapy might be the choice that's right for you. The relative safety of receiving a known regimen might be reassuring to those who discover that they have not been randomized to the new treatment arm.
• A phase III trial in which all patients receive the new drug and only an ancillary feature of treatment (such as one antibiotic against another to control infection) is randomized might be as good a choice as a phase II trial of a less well-known substance.
• A phase II trial of a very promising substance might appeal to patients who find phase I trials too risky and phase III trials too controlled.
• A phase I trial of a drug with a long, safe history of use for another illness might be a reasonable choice for you if animal studies have shown that the agent is active against lung cancer and if you have tried other treatments without success.

Where are clinical trials run?
Clinical trials are found most often at NCI-designated Comprehensive Cancer Centers, Clinical Cancer Centers, and at other university medical hospitals that receive federal funding and cooperate with the NCI on clinical trials. Your community oncologist may participate through association with the NCIs community clinical oncology programs. See Chapter 3, Finding the Right Treatment Team, for more information on NCI-designated cancer care centers.

Finding trials for lung cancer
If you're an adult with lung cancer, you must take an active role in finding the best care for your disease. Adults with cancer are seldom asked to join a trial unless they are being treated in a regional cancer care center. (The approach needed by adults is different from that for children with cancer, whose families are commonly approached regarding enrollment in clinical trials, and 75 percent of whom eventually are enrolled in clinical trials.) The NCl estimates that less than 5 percent of adults eligible for clinical trials enroll and that minorities are underrepresented in the clinical trial process.
Geri Capasso tells of her brother Anthonys participation in one clinical trial and their search for others:
It has been a difficult week for my brother. Two weeks ago when he went for his Gemzar treatment, his oncologist said he had bronchitis and sent him home with antibiotics. He was very fatigued, and by last weekend he could hardly breathe. He went to the ER last Sunday and is still in the hospital. On Monday, they drained 1.5 liters of fluid from his lung area. The biopsy of the fluid was cancer. His oncologist said that his CT scan showed significant growth, and consequently discontinued the Gemzar/cisplatin chemo treatment. He is still taking a double-blinded trial drug AG3340.
On Wednesday, he got a port and began Taxotere. His breathing was still labored, and his oncologist saw growth in the heart area, so he had an echocardiogram and was put into the cardiac care unit. Early Thursday, a heart surgeon drained the fluid around his heart. His oncologist has suggested talc to stop the fluid leakage. We are praying that the Taxotere works, and we sent fluid to the Weisenthal chemosensitivity lab in California for testing with different chemos. We are considering Thalidomide and looking into new trials. My brother is still Jull of fight, for which I'm thankful, but I just hope that we can find the right treatment.

The Following Tuesday, my brother Anthony had a talc procedure to scar the lining of the lungs to stop fluid leakage. He finally didn't need the oxygen by Friday, when he began Thalidomide, and we discontinued his participation in the double-blinded Phase III clinical trial of AG3340 a really don't think he was getting the real drug).
Meanwhile, he had CT scans and a brain MRI, and a "speck" showed up, so yesterday he had a spinal tap; the fluid was replaced with a chemotherapy agent. We sent the MRI film to Staten Island Hospital for review. Today he started Taxol.
Based on the chemosensitivity report, Taxol was active with his cancer cells. He is still taking Thalidomide. We had a stain test to see if he expressed Epithelial Growth Factor (EFG) and it came back positive.
We are looking into experimental drugs Iressa and ZD1839. Today he got out of the hospital, and he looks great and is breathing fine. He is physically and mentally ready to continue this fight. I'm so glad for that!
Several weeks later she says:

I'm very excited and have my fingers crossed. My brother began a clinical trial For the anti-EGF drug that Pfizer makes. It's similar to Iressa and ImClone's C22S. We had previously been turned down by the FDA in requesting C22S on a compassionate plea. He has tested positive For over expression of EGF, and I hope that he gets the same good results as others have. He is hanging in there, only using his 02 sparingly, the second talc treatment seems to be holding against pleural effusion. He hasn't had any more problems with blood clots, and the Aredia seems to be holding the bone metastases at bay. According to the latest CT scan, his liver has about 70 percent functioning capacity, and as his oncologist nicely put it, "you can Junction with 30 percent." So there are rays of sunshine here and there.
You can use several methods to find clinical trials:
• Ask your oncologist which trials would suit your medical circumstances. This has its advantages and disadvantages, one advantage being that you need to do very little except trust. The disadvantages are described in the next section, "Why research trials on your own?"
• Call the National Cancer Institute at (800) 4-CANCER and ask about trials for your subtype of lung cancer, being sure to ask for the full document, not the summary, and to specify whether you're willing to travel-s-otherwise they'll send you local trials only Be warned that if you call often with this request, which is not an unreasonable thing to do, because new trials are added every month, eventually they may decline to send you any more listings. This has been the experience of some cancer survivors who've used this service, which is provided by various regional cancer care centers under the auspices of the NCI.
• Research US and international clinical trials on your own at the NCI's web site, http://cancernet.nclnih.gov . This, in conjunction with learning to use Medline, is by far the most comprehensive way to check on new treatments being tested. This service alone may be worth the cost of a personal computer and the time spent learning to use it. At one time, Medline was available only to those who subscribed to the NCI's Information Associates' program for an annual fee, but now the NCI provides this tool free of charge on the Internet. Note that you should examine all trials available for lung cancer, not just those in your area.
• Contact pharmaceutical companies or visit their web sites to see what trials they offer. You can also see a list of pharmaceutical web sites at Karen Parles' http:// lungcanceronline. org.
• Use CenterWatch (http://www.centerwatch.com) to track new cancer treatment trials. Center Watch has improved their service greatly in the last few months, adding new information that shows what agent is being tested and at what center the trial is being held, instead of only a general trial title and city (This additional information is imperative if you're searching for trials at a top-notch cancer center in a large urban area.) The listings are still by state, however, forcing you to review some of the same information over and over for each state if you're willing to travel and want to be familiar with all trials available.
• Use the services of commercial Internet service providers, such as America Online (AOL), to receive email press releases from pharmaceutical companies concerning new products in development. Be aware, though, that press releases often will simply echo in less detail the medical information that you may already have found elsewhere. Furthermore, press releases typically are written to attract or reassure investors, rather than to impart fully accurate information to cancer survivors.

Why research trials on your own?
Some people who have depended only on their oncologists for comprehensive and up-to-date information on clinical trials have been disappointed. In many cases, oncologists in clinical practice-and that means most oncologists-are aware only of the high-priority trials that receive emphasis in such publications as Oncology Times or those that are offered nearby Some still do not use a computer to search the NCI's database for all applicable trials. Perhaps they haven't the time to do so: remember that most oncologists in the trenches must track information on every cancer known, whereas you have the opportunity to focus intensely on your own cancer, subtype, and stage.
At the other end of the lung cancer oncologist spectrum is the oncologist associated with a university medical school or cancer research center. You can usually expect very good to excellent treatment from such a specialist, but often, when consideration of clinical trials is appropriate, they are biased toward their own research or toward trials run by colleagues at their own institution.

The following story is an all too common example of our need to educate ourselves about clinical trials:
Several months ago, I had a phone call from a friend who now has a second cancer, a lymphoma, following treatment as a child for bone cancer. She thanked me for sending her information on the FDlts approval of a new monoclonal antibody treatment for lymphoma.

She was originally enrolled in an antiviral trial at a prestigious east coast cancer center, but the trial was halted following concerns about safety. When she showed her doctors the information on the new monoclonal antibody, they immediately put her on it. "They had never heard of it," she said.
The ideal oncologist is one somewhere in the middle: educated about most trials, able to find information quickly on new trials, aware of what's a good fit for you, but not biased toward her own work or that of colleagues.
Life doesn't often approach the ideal, so it's a good idea to learn to search for clinical trials on your own and to repeat your search every month, because new trials are constantly opening.

At the time of this writing, there are 105 trials for non-small cell lung cancer and 40 for small cell lung cancer. Once you have found a trial for which you believe you qualify, you should bring it to your doctors attention. Suppose you find several trials that seem to admit patients with your profile? How can you tell which trial would be best for you? Clearly this is one of the most important questions that will arise in your experience with lung cancer.

At this point, you need to acquire skills for searching Medline and reading the studies that result from your searches. The substances used in each clinical trial may have results published regarding their previous use in animals or in humans. These studies should be found, evaluated, and compared, by you and your doctor, to single out the substance most likely to benefit you. Detailed techniques for searching Medline are discussed in Chapter 22, Researching Your Illness.

If your oncologist is unwilling to help you, is negative, or is at best ho-hum about your proactive attitude toward searching for trials, find a new doctor, because you'll need a doctors recommendation to get admitted to a trial.

Getting admitted to a trial
Once you have found one or more clinical trials that you think you're eligible for, you must ask your oncologist to consult with and refer you to the treatment center running the trial for an evaluation to be admitted. If your doctor is unwilling to do so, seek a second opinion. You might try phoning the principal investigator listed in the trial description. Many principal investigators are willing to speak directly with prospective patients about the details of the trial and the patient's medical history The names and phone numbers of the principal investigator and participating doctors can be found at the end of the document that describes the clinical trial.

You and your medical records will be scrutinized closely by your doctor, the doctors at the institution offering the trial, and perhaps your insurance company, to see if you're truly a candidate. Various physical parameters, such as the condition of your lungs and liver, may be factors. The kind of tumor you have, how large it is, or whether your disease is progressing must be considered.

One of the chief considerations in evaluating patients for most clinical trials is how much previous treatment they've had and what kind. Some trials want only those who have been heavily pretreated; others require patients who have not had any treatment resembling that proposed for the trial. Still others seek patients who have had no treatment at all.
You should read all of the entry criteria listed for the clinical trial and become very familiar with the results of your various tests so you'll have a good idea whether you're eligible before you approach your doctor for a referral. Questions that many other cancer survivors feel overwhelmed by-such as how long the trial will run, where it is located, and what the side effects are-will not be a problem for you because the description of the study will have answered many of these questions for you.
In order for you to be accepted, there may need to be a great deal of rapid crosscommunication among you; your medical care providers; your insurance company, which will almost certainly insist on pre-approval; the oncology nurse in charge of administering the trial at the center you've targeted; the social worker; the housing assistant (if you must travel for this care); and the principal investigator (an MD) running the trial. You may need to make one or more trips to the cancer center for an evaluation. You may be pleasantly surprised by how kindly you're treated-some doctors phone personally, for instance--or you may be dismayed by lost records, lack of communication, and red tape. Other patients experience heartache and anger when, after passing all the benchmarks, a reviewing MD employed by their insurance company denies payment for the treatment after finding some discrepancy More on this topic is discussed later in the section "About payment."
The evaluation process is the time to ask for your own copy of the full protocol. The protocol is the lengthy, fully detailed document that describes what will be done, when, and what action will be taken if certain undesirable effects occur. You should always ask for, and read thoroughly, a copy of the full protocol.
Do not sign a consent form until you have received and read a copy of the full protocol and have considered all other clinical trials for which you might be eligible.

You can expect to feel conflicting emotions at this time. The excitement of finding a treatment that may be more effective than current treatments, the fear that the treatment might have unknown effects, concerns about being away from home, nagging worries about financial considerations, and the thrill of empowerment on finding the best care may suddenly emerge as overwhelming feelings after months of relatively calm feelings about coping with your illness.
No doubt the very detailed information that is part of the full protocol will answer many of your questions and will trigger several others. In addition, consider these less-than-obvious questions, which are adapted from Nancy Keenes book, Working With Your Doctor (O'Reilly, 1998):
• Who reviews this study, and how often'
• Who monitors patient safety?
• Why do you believe that this treatment is better than standard treatment?
• What are the potential short- and long-term side effects of this treatment'
• Will participation in the study mean that I have to change oncologists?
• Must I be hospitalized to participate'
• What will be my costs, and what will my health insurance pay'
• Does the study follow patients for the long term'
• Who pays for any care I'll need if the treatment has negative effects?
Once you're enrolled

Detailing exactly what to expect after you're enrolled in a clinical trial is not possible in this or any book because each trial is quite different; but, in general, most people find they feel well cared for in a trial setting. It might be wise, however, to expect the unexpected. One cancer survivor, for example, traveled a great distance to take part in a clinical trial, only to be told upon arrival that the trial had been closed because of safety concerns. Others meet delays because the paperwork necessary was never forwarded by those who promised to do so, especially insurance company preapprovals for payment.
Once treatment is underway, some people are surprised that the extensive and detailed protocol outlining the treatment really is just a guideline. Although a great deal of homage is paid to adhering to the protocol for the sake of science, the truth is that the protocol can be changed if you're suffering adverse effects. This is particularly true in a phase I trial thats measuring toxicity.

If at all possible, have a friend or relative with you during treatment to verify what medications are given, to provide emotional support, and to be an advocate if you need one. This is especially important if you have traveled some distance for care or are using morphine, for example, to control side effects.
Remember that you have the right to withdraw at any time from a clinical trial, to read your medical records, and to ask that deviations from the protocol be made if you're experiencing very bad side effects.

Experimental drugs outside clinical trials
There are several ways, other than clinical trials, to obtain drugs that are still in testing phases. See the FDA web site (http://wwwjda.gov/cder/cancer/access.htm) for information about their regulations: "If the eligibility criteria in a study protocol are not suitable for a particular patient, it may still be possible to be treated according to the study protocol as a special exception (sometimes called compassionate exemption) ... Another alternative is for a physician to file a Single patient or emergency IND directly with the FDA.

Investigational new drugs (IND)
Gaining early access to drugs still being tested is possible under the FD& treatment Investigational New Drug (IN D) program, sometimes called the compassionate use program. This access is reserved for those with life-threatening diseases that have no other satisfactory treatment. According to FDA statistics, since 1987 more than 20,000 patients with cancer have received treatment under a treatment IND. For more information, contact your doctor, the drug manufacturer, or the FDA at (800) 532-4440.
Paralleling a trial
Once the FDA approves a drug for a given condition (commonly referred to as its indication), a doctor is free to prescribe this drug for any illness. This is called offlabel use and demonstrates the FD~s faith in the medical communitys integrity and knowledge.

If a clinical trial is testing drugs or radiation therapy techniques that are already approved by the FDA, but in new combinations or at new dose levels, your doctor might be willing to administer these to you as they would have been given within the trial. Contact your oncologist for more information.

Importation of a foreign drug
If an illness has no cure using drugs currently approved by the FDA, drugs made in foreign countries might be imported. Only those drugs meeting strict FDA regulations, though, are permitted. Among other requirements, the manufacturer must file an investigational new drug application with the FDA, and a letter justifying importation must accompany the request. For more information, contact your doctor and contact the FDA CDER division at (888) 463-6332.

About payment
Many people have found that they have difficulty getting their insurance companies to approve payment for care administered under the auspices of a clinical trial or for an investigational new drug.
One might surmise that, because cancer is a very expensive chronic disease, it would be to the financial benefit of insurance companies if better treatments were found. Nonetheless, individual companies often are unwilling to assume the costs of these studies. The trend, however, is that more companies are paying for trials than in the past or can be convinced to make exceptions for those who need treatment in trials.

The federal government has set a good example by ruling that federally insured employees will be covered for their treatment within Ncr-sponsored clinical trials. Rhode Island has passed a law requiring insurance companies to pay for cancer clinical trials. The State of Maryland has passed similar legislation that will require payment of fees for treatment given as part of a clinical trial for any illness, as long as the trial is NIH-approved. Contact your state health commissioner to determine if your state has enacted similar laws.

Some cancer survivors have had success getting insurance payment approval by having their doctors supply evidence that previous tests of the new treatment showed some superiority over existing treatments, or by writing "letters of necessity" demonstrating that this experimental treatment is the only good choice available. Others have luck when their employers intervene, especially if the employer is self-insured. Still others use the news media to generate publicity that is embarrassing for the insurance company Some cancer facilities offering clinical trials make provisions for those who want to participate but cannot pay

IND programs may offer drugs at a reduced price.
Importation of foreign drugs for single-patient use under the FDAs strict guidelines will almost certainly be an expense you'll have to bear on your own, but do check with your health insurance company, because policies vary widely
An excellent source of additional information on negotiating for payment of treatment is Nancy Keene's book, Working With Your Doctor (O'Reilly, 1998).

Free treatment
The National Cancer Institute in Bethesda, Maryland, offers free treatment for those who qualify for their trials. This is a top-notch scientific institution run by the federal government, and has some of the best cancer researchers in the country. Those who have used their services sometimes say, though, that they were very aware that they were in a research setting, as opposed to a setting oriented toward patient care and comfort. Call (800) 4-CANCER.
Non-US citizens are also admitted to trials at the NCI at the discretion of the principal investigator. Criteria that are weighed in making this decision include whether a US citizen would be denied treatment if a non-US citizen were enrolled and whether treating this particular individual's illness would benefit medical progress.

Summary
The NCI recommends that clinical trials, a means of testing new therapies in order to improve cancer treatment, can be a good choice for those with small cell lung cancer or non-small cell lung cancer at stages beyond lAo It is most wise to become familiar with clinical trials before you think you'll need one because the effort involved might require time and energy
Clinical trials are organized into three phases that evaluate increasingly complex aspects of treatment success. Each phase has its advantages and disadvantages. A careful assessment of all clinical trials is necessary to choose the one that's best for your circumstances.

Patient rights and safeguards are carefully observed in the clinical trial setting. You are free to withdraw at any time, and you cannot be denied care if you do so.
You can find information on clinical trials by asking your oncologist, calling the NCI at (800) 4-CANCER, or searching for trials on your own.

Being admitted to a trial may be preceded by a flurry of administrivia surrounding your evaluation that may thrill you with its cut-to-the-chase aspect or may disappoint you with delays and miscommunications. The administrative offices of certain cancer care centers can be quite disorganized in spite of the institution's fine reputation for practicing excellent medicine.
Plan to have a friend or loved one act as an advocate for you during your treatment. It can be difficult to resolve certain problems, especially if you're far from home or using morphine, for example, to control side effects. Your emotional reactions might be surprising and conflicting, but overall you can probably expect to be confident that you've made a good choice.

Nice knowledge which you are spreading. I don't know anything about this clinical trial but by reading all this i know everything.