Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Objectives

I.  Compare local recurrence rates, rates of distant metastasis, 
recurrence-free survival, and overall survival in patients having potentially 
curative resections of Dukes B2 and C rectal carcinoma treated either with 
postoperative radiation alone or with sequential chemotherapy using 
methyl-CCNU and 5-fluorouracil plus postoperative radiation.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically proven 
Dukes B2 or C adenocarcinoma of the rectum in whom a potentially curative 
resection has been performed with neither gross nor microscopic evidence of 
residual disease.  There may have been no prior chemotherapy nor radiotherapy 
to the pelvis.  Bone marrow function must be adequate and the patient must 
have recovered from the acute effects of surgery and be maintaining normal 
oral nutrition.  There may be no history of any malignant disease within the 
previous 5 years other than squamous or basal cell carcinoma of the skin or in 
situ carcinoma of the cervix.

Expected Enrollment

200 patients will be accrued.

Outline

Randomized study.
Arm I:  Radiotherapy.  Postoperative pelvic irradiation using supervoltage 
equipment (Co60 or linear accelerator).
Arm II:  Radiotherapy plus 2-Drug Combination Chemotherapy.  Radiotherapy as 
in Arm I; plus Methyl-CCNU, MeCCNU, NSC-95441; 5-Fluorouracil, 5-FU, NSC-19893.

O'Connell M, Martenson J, Rich T, et al.: Protracted venous infusion (PVI) 5-fluorouracil (5FU) as a component of effective combined modality postoperative surgical adjuvant therapy for high-risk rectal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-564, 193, 1993.

Krook JE, Moertel CG, Gunderson LL, et al.: Effective surgical adjuvant therapy for high-risk rectal carcinoma. N Engl J Med 324 (11): 709-15, 1991.[PUBMED Abstract]

Gunderson LL, Sargent DJ, Tepper JE, et al.: Impact of T and N stage and treatment on survival and relapse in adjuvant rectal cancer: a pooled analysis. J Clin Oncol 22 (10): 1785-96, 2004.[PUBMED Abstract]

Gunderson LL, Haddock MG, Schild SE: Rectal cancer: Preoperative versus postoperative irradiation as a component of adjuvant treatment. Semin Radiat Oncol 13 (4): 419-32, 2003.[PUBMED Abstract]

Gunderson LL, Sargent DJ, Tepper JE, et al.: Impact of T and N substage on survival and disease relapse in adjuvant rectal cancer: a pooled analysis. Int J Radiat Oncol Biol Phys 54 (2): 386-96, 2002.[PUBMED Abstract]

Donohue JH, Williams S, Cha S, et al.: Perioperative blood transfusions do not affect disease recurrence of patients undergoing curative resection of colorectal carcinoma: a Mayo/North Central Cancer Treatment Group study. J Clin Oncol 13 (7): 1671-8, 1995.[PUBMED Abstract]

Douglass HO Jr, Moertel CG, Mayer RJ, et al.: Survival after postoperative combination treatment of rectal cancer. N Engl J Med 315 (20): 1294-5, 1986.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles G. Moertel, MD, Protocol chair (Contact information may not be current)		Ph: 507-284-5999

Mayo Clinic Cancer Center

Charles G. Moertel, MD, Protocol chair (Contact information may not be current)		Ph: 507-284-2511

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