Head and Neck Cancer — Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer
Citation(s)
Ang KK, Harris J, Garden AS, et al : Concomitant boost radiation and concurrent cisplatin for advanced head and neck carcinomas: preliminary results of a phase II trial of the RTOG (99-14). [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-123, 71,
Garden AS, Harris J, Jones CU, et al : Concomitant boost radiation and concurrent cisplatin for advanced head and neck carcinomas: update of a phase II trial of the RTOG (99-14). [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-117, S71, 2005.
Machtay M, Moughan J, Trotti A, et al : Pre-treatment and treatment related risk factors for severe late toxicity after chemo-RT for head and neck cancer: an RTOG analysis. [Abstract] J Clin Oncol 24 (Suppl 18): A-5500, 280s, 2006.
O'Meara EA, Machtay M, Moughan J, et al : Associations between radiation doses to pharyngeal regions and severe late toxicity in head and neck cancer patients treated with concurrent chemoradiotherapy: an RTOG analysis. [Abstract] Int J Radiat Oncol Biol Phys 69 (3): A-96, S54-5, 2007.
A Phase II Trial of Concomitant Boost Radiation and Concurrent Cisplatin for Advanced Head and Neck Carcinomas
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.