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

James A. Martenson, Christopher G. Willett, Daniel J. Sargent, James A. Mailliard, John H. Donohue, Leonard L. Gunderson, Charles R. Thomas, Barbara Fisher, Al Bowen Benson, Robert Myerson, Richard M. Goldberg

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)3277-3283
Number of pages7
JournalJournal of Clinical Oncology
Volume22
Issue number16
DOIs
StatePublished - 2004

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Adjuvant Chemotherapy
Colonic Neoplasms
Radiotherapy
Drug Therapy
Therapeutics
Disease-Free Survival
Descending Colon
Ascending Colon
Levamisole
Survival
Leukopenia

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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. / Martenson, James A.; Willett, Christopher G.; Sargent, Daniel J.; Mailliard, James A.; Donohue, John H.; Gunderson, Leonard L.; Thomas, Charles R.; Fisher, Barbara; Benson, Al Bowen; Myerson, Robert; Goldberg, Richard M.

In: Journal of Clinical Oncology, Vol. 22, No. 16, 2004, p. 3277-3283.

Research output: Contribution to journalArticle

Martenson, JA, Willett, CG, Sargent, DJ, Mailliard, JA, Donohue, JH, Gunderson, LL, Thomas, CR, Fisher, B, Benson, AB, Myerson, R & Goldberg, RM 2004, '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', Journal of Clinical Oncology, vol. 22, no. 16, pp. 3277-3283. https://doi.org/10.1200/JCO.2004.01.029
Martenson, James A. ; Willett, Christopher G. ; Sargent, Daniel J. ; Mailliard, James A. ; Donohue, John H. ; Gunderson, Leonard L. ; Thomas, Charles R. ; Fisher, Barbara ; Benson, Al Bowen ; Myerson, Robert ; Goldberg, Richard M. / 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. In: Journal of Clinical Oncology. 2004 ; Vol. 22, No. 16. pp. 3277-3283.
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abstract = "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.",
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T1 - Phase III study of adjuvant chemotherapy and radiation therapy compared with chemotherapy alone in the surgical adjuvant treatment of colon cancer

T2 - Results of intergroup protocol 0130

AU - Martenson, James A.

AU - Willett, Christopher G.

AU - Sargent, Daniel J.

AU - Mailliard, James A.

AU - Donohue, John H.

AU - Gunderson, Leonard L.

AU - Thomas, Charles R.

AU - Fisher, Barbara

AU - Benson, Al Bowen

AU - Myerson, Robert

AU - Goldberg, Richard M.

PY - 2004

Y1 - 2004

N2 - 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.

AB - 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.

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