Originally published as JCO Early Release 10.1200/JCO.2004.01.029 on July 12 2004

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Phase III Study of Adjuvant Chemotherapy and Radiation Therapy Compared With Chemotherapy Alone in the Surgical Adjuvant Treatment of Colon Cancer: Results of Intergroup Protocol 0130

From the North Central Cancer Treatment Group; Mayo Clinic, Rochester, MN; Radiation Therapy Oncology Group, Philadelphia, PA; Missouri Valley Cancer Consortium, Omaha, NE; Southwest Oncology Group, San Antonio, TX; National Cancer Institute of Canada—Clinical Trials Group, Kingston, Ontario, Canada; Eastern Cooperative Oncology Group, Boston, MA; Cancer and Leukemia Group B, Chicago, IL

Address reprint requests to James A. Martenson, MD, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: jmartenson{at}mayo.edu

PURPOSE: Some patients with colon cancer have a high risk of local recurrence postoperatively. This trial was undertaken to determine whether radiation therapy added to an adjuvant chemotherapy regimen improves outcome in high-risk patients.

PATIENTS AND METHODS: Patients with resected colon cancer with tumor adherence or invasion of surrounding structures, or with T3N1 or T3N2 tumors of the ascending or descending colon were randomly assigned to receive fluorouracil and levamisole therapy with or without radiation therapy. Patients who received chemotherapy and radiation therapy (chemoRT) received 45 to 50.4 Gy in 25 to 28 fractions beginning 28 days after starting chemotherapy. Patient enrollment was terminated because of slow accrual after 222 patients enrolled (original goal was 700 patients); 187 patients were assessable.

RESULTS: Overall 5-year survival was 62% for chemotherapy patients and 58% for chemoRT patients (P > .50); 5-year disease-free survival was 51% for both groups (P > .50). Toxicity ( grade 3) occurred in 42% of chemotherapy patients and 54% of chemoRT patients (P = .04). Leukopenia ( grade 3) occurred in 10% of chemotherapy patients and 22% of chemoRT patients (P = .02). No significant difference in nonhematologic toxicity ( grade 3) was observed between chemoRT and chemotherapy patients (35% v 44%; P = .26).

CONCLUSION: Patients who received chemotherapy or chemoRT had similar overall survival and disease-free survival. Toxicity was higher among chemoRT patients. These results must be interpreted with caution because of the high number of ineligible patients and the limited power of the study to detect potentially meaningful differences.

Supported in part by Public Health Service grants CA 25224, CA 37404, CA 15083, and CA 63849; CA 21661, CA 37422, and CA 32115 (Radiation Therapy Oncology Group); CA 32102 and CA 22433 (Southwest Oncology Group); CA 21115 (Eastern Cooperative Oncology Group); CA 31946 and CA 774400 (Cancer and Leukemia Group B); and a grant from the National Cancer Institute of Canada (NCIC 4448).

Presented in part at the 35th Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, May 15, 1999.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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