Protocol Title:

Postoperative Evaluation of 5-FU by Bolus Injection Vs 5-FU By Prolonged Venous Infusion Prior To And Following Combined Prolonged Venous Infusion_Plus Pelvic XRT VS_Bolus 5-FU Plus Leucovorin Plus Levamisole Prior To And Following_Combined Pelvic XRT In Patients With Rectal Cancer, Phase III/Intergroup

Protocol Status:

Closed

Protocol Number:

R 9403

Type of Cancer:

Rectal

Principal Investigator:

Danny Song, M.D.

Phase Number:

III

Summary:

Study was closed to accrual on 8/1/00. 1,917 patients had been accrued nationally. The study closed to accrual on August 1, 2000.
Eight patients were accessioned by Johns Hopkins. Two patients were randomized to ARM I (Bolus 5-FU + XRT), one patient was randomized to ARM II (P15VI 5-FU + XRT) and five patients were randomized to Arm III (Bolus 5-FU + LV + LEV + XRT). Two patients on Arm III recurred and expired from progressive disease. One patient on ARM III expired due to non-cancer related illnesses. One patient on ARM III is alive with no evidence of disease, and one patient on ARM III is alive but has recurred. The patient on ARM II is alive with no evidence of disease. One patient on ARM I is alive with no evidence of disease but the other patient on ARM I has expired (cause unknown). All eight patients enrolled at Johns Hopkins have completed their therapy (last patient enrolled completed his therapy in the end of 2000).