Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer

Summary

This randomized phase III trial is comparing the effectiveness of three adjuvant combination chemotherapy regimens in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for stage II or stage III rectal cancer. Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which adjuvant combination chemotherapy regimen is more effective in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for rectal cancer.

Timeline

Start

2003-10-15

Primary completion

2016-11-15

Completion

2016-11-15

Outcome

Missed primary endpoint

registry analysis (superiority test); Irinocetan (Arm I) vs Control (Arm III); p = 0.35; Log Rank; note: One-sided p value was reported NCT00068692 ↗

registry analysis (superiority test); Oxaliplatin (Arm II) vs Control (Arm III); p = 0.69; Log Rank; note: one-sided p value was reported NCT00068692 ↗

paper At a median follow-up of 9.7 years, no significant OS or DFS differences were observed. PMID 41397917 ↗

Publications

• Kam AE, Zhao F, Meropol NJ, Giantonio BJ, Diasio RB, Flynn PJ, Catalano P, Hartner L, Rowland KM, Song W, Mulcahy MF, Sinicrope FA, Whitehead RP, Mayer RJ, Petrelli N, O'Dwyer PJ, Hamilton SR, Cella D, Benson AB. Intergroup randomized phase III study of adjuvant FOLFIRI, FOLFOX, or 5-FU/leucovorin for stage II/III rectal cancer: ECOG-ACRIN E3201. Oncologist. 2025 Dec 27;31(1):oyaf416. doi: 10.1093/oncolo/oyaf416.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	—	Intravenous
Subject	Leucovorin	Small molecule	—	Intravenous
Subject	Oxaliplatin	Small molecule	—	Intravenous
Subject	fluorouracil	Small molecule	—	Intravenous

Indications