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NCI HIGH PRIORITY CLINICAL TRIAL --- Phase III Randomized Comparison of Adjuvant Chemotherapy with MOF (MeCCNU/VCR/5-FU) with and without Radiotherapy vs 5-FU plus High-Dose CF with and without Radiotherapy Following Curative Resection of Dukes' B and C Adenocarcinoma of the Rectum

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 to 70NCINSABP-R-02
NCOG-NSABP-R-02

Objectives

I.  Determine, in a randomized Phase III setting, whether the addition of 
radiotherapy to combination chemotherapy with MOF (methyl 
CCNU/vincristine/5-fluorouracil) or 5-fluorouracil plus high-dose leucovorin 
is more effective than chemotherapy alone in improving disease-free survival 
and overall survival in patients who have undergone potentially curative 
resection of Dukes' B or C adenocarcinoma of the rectum.
II.  Randomly compare the disease-free survival and overall survival of 
patients who have undergone potentially curable resection of Dukes' B or C 
adenocarcinoma of the rectum who receive adjuvant chemotherapy with MOF vs. 
5-fluorouracil plus high-dose leucovorin.

Entry Criteria

Disease Characteristics:


Histologically documented Dukes' B or C adenocarcinoma of
the rectum that has undergone potentially curative surgical
resection

  To be classified as a rectal tumor, determination of
  distal extent of tumor must have required opening of
  pelvic peritoneum

  More than 1 synchronous rectal tumor allowed;
  classification based on histologic stage of more advanced
  primary tumor

  Direct extension into adjacent structures such as bladder,
  small intestine, or ovary permitted provided en bloc
  resection was effected and resection was potentially
  curative as confirmed histologically by tumor-free margins

No multiple primary tumors involving both rectum and colon

Intestinal obstruction allowed; preliminary or complementary
colostomy permitted

Free perforations (as manifested by free air in the abdomen)
exclude, but walled-off perforations permitted

Randomization must occur within 42 days postoperatively

  Postoperative complications permitted provided systemic
  therapy can begin 42 days postoperatively


Prior/Concurrent Therapy:


Biologic therapy:
  No prior therapy

Chemotherapy:
  No prior therapy

Endocrine therapy:
  No prior therapy

Radiotherapy:
  No prior therapy

Surgery:
  Potentially curative resection required


Patient Characteristics:


Age:
  18 to 70

Performance status:
  ECOG 0-2

Hematopoietic:
  WBC at least 4,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dl
  SGOT or SGPT no greater than 60 IU/ml
  GGTP no greater than 70 IU/ml in men and 30 IU/ml in women
  No hepatic disease that would preclude protocol therapy

Renal:
  Creatinine no greater than 1.5 mg/dl
  No renal disease that would preclude protocol therapy

Cardiovascular:
  No cardiovascular disease that would preclude protocol
  therapy

Other:
  No other nonmalignant systemic disease that would preclude
  protocol therapy

  No previous or concomitant second malignancy except:
    Adequately treated nonmelanomatous skin cancer
    Adequately treated in situ cervical cancer

  No psychiatric or addictive disorders that would preclude
  informed consent

  No pregnant women

  CEA determination optional preoperatively, required
  postoperatively; results need not be known at randomization


Expected Enrollment

750 patients will be accrued over about 5 years.

Outline

Randomized study.  Male patients are randomized to all 4 arms, while females 
are randomized to Arms III and IV only.
Arm I:  3-Drug Combination Chemotherapy.  MOF:  Methyl CCNU, MeCCNU, 
NSC-95441; Vincristine, VCR, NSC-67574; 5-Fluorouracil, 5-FU, NSC-19893.
Arm II:  3-Drug Combination Chemotherapy plus Radiotherapy.  MOF; plus pelvic 
irradiation using megavoltage photon beams with minimum energies of 4 MeV or 
Co60.
Arm III:  Single-agent Chemotherapy plus Biochemical Modulation.  5-FU; plus 
High-dose Leucovorin, Citrovorum Factor, CF, NSC-3590.
Arm IV:  Single-agent Chemotherapy plus Biochemical Modulation plus 
Radiotherapy.  5-FU; plus High-dose CF; plus pelvic irradiation as in Arm II.

Published Results

Wolmark N, Wieand HS, Hyams DM, et al.: Randomized trial of postoperative adjuvant chemotherapy with or without radiotherapy for carcinoma of the rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02. J Natl Cancer Inst 92 (5): 388-96, 2000.[PUBMED Abstract]

Rockette H, Deutsch M, Petrelli N, et al.: Effect of postoperative radiation therapy (RTX) when used with adjuvant chemotherapy in Dukes' B and C rectal cancer: results from NSABP R-02. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-560, 193, 1994.

Related Publications

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]

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

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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