Clinical trials test whether an experimental treatment is safe and effective. Also referred to as studies or clinical research, trials are designed to answer specific questions including:
- Is the experimental treatment well tolerated by patients?
- Does it have a beneficial therapeutic effect?
- Is it better than standard therapy or other treatments that are available?
Complete list of Thoracic Oncology Clinical Trials
UCSF is a primary testing site for new cancer therapies. Our studies include novel targeted agents, surgery, chemotherapy, radiation, and cancer vaccines.
| Surgery | Operation to remove a tumor |
| Chemotherapy | A systemic treatment with anti cancer drugs given intravenously orally, or topically |
| Radiation | High-energy radiation to kill cancer cells |
| Targeted Therapy | Drugs that target only tumor cells, sparing normal tissue |
| Cancer Vaccines | A treatment designed to produce an immune response in a tumor |
Clinical trials are investigational in nature. There is no guarantee a drug will work, but if it does, trial participants may be among the first to benefit. The FDA has approved a number of new drugs for lung cancer in recent years including Tarceva ® (erlotinib), Avastin ® (bevacizumab), and Alimta ® (pemetrexed). Without clinical trial participation, none of these could have been approved.
Each trial has a protocol that serves as a roadmap for the trial. The protocol includes information about:
- Goals of the Trial
- Risks and Benefits for Patients
- Description of Experimental treatment
- Patient eligibility
- Conduct of the trial
- Information to be collected
Patients receive very detailed information about the potential risks and benefits before enrollment as part of the process of informed consent.
Phase I
These trials are the first step in testing a new approach in people. In these studies, researchers evaluate what dose is safe, how a new agent should be given (by mouth, injected into a vein, or injected into the muscle), and how often. Researchers watch closely for any harmful side effects. Phase I trials usually enroll a small number of patients and take place at only a few locations. The dose of the new therapy or technique is increased a little at a time. The highest dose with an acceptable level of side effects is determined to be appropriate for further testing. These trials involve a small number of patients -- usually no fewer than 20 and no more than 80.
Phase II
These trials study the safety and effectiveness of an agent or intervention, and evaluate how it affects the human body. Phase II studies usually focus on a particular type of cancer, and include fewer than 100 patients. These studies involve larger numbers of patients -- typically 1,000 to 3,000.
Phase III
These trials compare a new agent or intervention (or new use of a standard one) with the current standard therapy. Participants are randomly assigned to the standard group or the new group, usually by computer. This method, called randomization, helps to avoid bias and ensures that human choices or other factors do not affect the study's results. In most cases, studies move into phase III testing only after they have shown promise in phases I and II. Phase III trials often include large numbers of people across the country, typically 1,000 to 3,000.