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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	under 80	NCI	NSABP-R-01 NCOG-NSABP-R-01

Objectives

I.  Obtain information to define subsets of rectal cancer patients at high 
risk of recurrence.
II.  Correlate pathologic and biologic parameters with disease-free interval 
and survival.
III.  Determine the value of surgical and ancillary techniques in management 
of rectal cancer.
IV.  Compare disease-free interval and survival after curative resection and 
postoperative radiotherapy or chemotherapy with 
5-fluorouracil/methyl-CCNU/vincristine.
V.  Relate the total lymphocyte count to the course of the disease.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients under the age of 80 years 
who have undergone resection for a potentially curable Dukes Stage B or C 
rectal adenocarcinoma.  Patients with involved adjacent structures are 
eligible if an en bloc resection has been carried out and the surgeon deems 
the procedure curative.  Patients with more than one rectal tumor are eligible 
provided that all tumors are curatively resected.  Preliminary or 
complementary colostomy does not exclude.  The performance status must be 0-2; 
liver, kidney, and bone marrow function must be adequate.  Patients with Stage 
A or D disease may be entered on the follow-up arm only.  There may be no 
previous or concomitant second malignancy with the exception of adequately 
treated nonmelanomatous skin cancer.  Patients may have received no 
radiotherapy, chemotherapy, or other surgery (except preliminary or 
complementary colostomy) for their current malignancy and may not have 
received prior irradiation to the tumor area.  There may be no nonmalignant 
systemic disease that would preclude any of the treatment options on this 
protocol, and patients may not expect a pregnancy to be carried to term.

Expected Enrollment

About 600-800 patients will be entered in 3-5 years.

Outline

Randomized study.  All patients with Dukes A or D lesions are treated on Arm 
I; all other patients are randomized to Arm I, II, or III following surgery.
Arm I:  No therapy following surgery.
Arm II:  Radiotherapy.  Postoperative irradiation of the entire pelvis using 
megavoltage equipment (Co-60, 4 to 10 MeV) or (if necessary) 250 kVp x-rays.
Arm III:  3-Drug Combination Chemotherapy.  5-Fluorouracil, 5-FU, NSC-19893; 
Methyl-CCNU, MeCCNU, NSC-95441; Vincristine, VCR, NSC-67574.

Johnston PG, Fisher ER, Rockette HE, et al.: The role of thymidylate synthase expression in prognosis and outcome of adjuvant chemotherapy in patients with rectal cancer. J Clin Oncol 12 (12): 2640-7, 1994.[PUBMED Abstract]

Fisher ER, Paik SM, Rockette H, et al.: Prognostic significance of eosinophils and mast cells in rectal cancer: findings from the National Surgical Adjuvant Breast and Bowel Project (protocol R-01). Hum Pathol 20 (2): 159-63, 1989.[PUBMED Abstract]

Fisher ER, Sass R, Palekar A, et al.: Dukes' classification revisited. Findings from the National Surgical Adjuvant Breast and Bowel Projects (Protocol R-01). Cancer 64 (11): 2354-60, 1989.[PUBMED Abstract]

Fisher ER, Siderits RH, Sass R, et al.: Value of assessment of ploidy in rectal cancers. Arch Pathol Lab Med 113 (5): 525-8, 1989.[PUBMED Abstract]

Fisher B, Wolmark N, Rockette H, et al.: Postoperative adjuvant chemotherapy or radiation therapy for rectal cancer: results from NSABP protocol R-01. J Natl Cancer Inst 80 (1): 21-9, 1988.[PUBMED Abstract]

Fisher B, Wolmark N, Rockette H, et al.: Adjuvant chemotherapy or post-operative radiation for rectal cancer: 5 year results of NSABP protocol R-01. [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-359, 92, 1987.

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]

Dignam JJ, Ye Y, Colangelo L, et al.: Prognosis after rectal cancer in blacks and whites participating in adjuvant therapy randomized trials. J Clin Oncol 21 (3): 413-20, 2003.[PUBMED Abstract]

Fisher ER, Colangelo L, Wieand S, et al.: Lack of influence of cytokeratin-positive mini micrometastases in "Negative Node" patients with colorectal cancer: findings from the National Surgical Adjuvant Breast and Bowel Projects protocols R-01 and C-01. Dis Colon Rectum 46 (8): 1021-5; discussion 1025-6, 2003.[PUBMED Abstract]

Wolmark N, Fisher B, Wieand HS, et al.: The prognostic significance of preoperative carcinoembryonic antigen levels in colorectal cancer. Results from NSABP (National Surgical Adjuvant Breast and Bowel Project) clinical trials. Ann Surg 199 (4): 375-82, 1984.[PUBMED Abstract]

Wolmark N, Fisher ER, Wieand HS, et al.: The relationship of depth of penetration and tumor size to the number of positive nodes in Dukes C colorectal cancer. Cancer 53 (12): 2707-12, 1984.[PUBMED Abstract]

Wolmark N, Wieand HS, Rockette HE, et al.: The prognostic significance of tumor location and bowel obstruction in Dukes B and C colorectal cancer. Findings from the NSABP clinical trials. Ann Surg 198 (6): 743-52, 1983.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

National Surgical Adjuvant Breast and Bowel Project

Norman Wolmark, MD, Protocol chair		Ph: 412-359-3336; 866-680-0004

Clinical Research Program - Northern California Cancer Center

Robert Carlson, MD, Protocol chair		Ph: 650-725-6457; 800-756-9000