NCT00002631 - Clinical Trial References

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.

Citation(s)

Kachnic LA, Scott C, Ginsberg R, et al
: One year follow-up reveals no difference in quality of life between high dose and conventional dose radiation: a quality of life assessment of RTOG 94-05. [Abstract] Int J Radiat Oncol Biol Phys 51 (3 suppl 1): A-1
Kachnic LA, Winter K, Wasserman T, Kelsen D, Ginsberg R, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Willett CG, Minsky BD
Longitudinal Quality-of-Life Analysis of RTOG 94-05 (Int 0123):A Phase III Trial of Definitive Chemoradiotherapy f
Minsky BD, Berkey B, Kelsen DK, et al
: Preliminary results of Intergroup INT 0123 randomized trial of combined modality therapy (CMT) for esophagel cancer: standard vs high dose radiation therapy. [Abstract] Proceedings of the American Society of Clinica
Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP
INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose
Smalley SR, Gunderson L, Tepper J, Martenson JA Jr, Minsky B, Willett C, Rich T
Gastric surgical adjuvant radiotherapy consensus report: rationale and treatment implementation. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):283-93.
Thomas CR Jr, Berkey BA, Minsky BD, Gaspar LE, Herskovic A, Rich TA, Gunderson LL
Recursive partitioning analysis of pretreatment variables of 416 patients with locoregional esophageal cancer treated with definitive concomitant chemoradiotherapy on Intergroup and Radiation Therapy Oncology Group trials. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1405-10.

A PHASE III INTERGROUP RANDOMIZED COMPARISON OF COMBINED MODALITY THERAPY FOR CARCINOMA OF THE ESOPHAGUS: HIGH-DOSE VS CONVENTIONAL-DOSE RADIATION THERAPY

Details for clinical trial NCT00002631

Clinical trial NCT00002631 - References