Phase III Randomized Study of Total Mesorectal Excision With vs Without Preoperative Radiotherapy in Patients With Primary Rectal Cancer (Summary Last Modified 03/2000)

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Alternate Title

Radiation Therapy Before or After Surgery in Treating Patients With Primary Rectal Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overDUT-KWF-CKVO-9504
EORTC-40971, EU-96020


I.  Compare the local control rate following standardized total mesorectal 
excision (TME) with or without preoperative radiotherapy in patients with 
primary rectal cancer.

II.  Compare the quality of life of patients in each treatment group.

III.  Achieve standardization and quality control of TME surgery and 
pathologic assessment in rectal cancer.

IV.  Assess the cost-benefit ratio associated with each treatment.

Entry Criteria

Disease Characteristics:

Histologically proven stage T2-3 primary adenocarcinoma of the rectum 
  Tumor located below S1/S2
  Distal border of tumor within 15 cm of the anal verge

Tumor judged to be clinically resectable with negative margins (R0)
  No tumors fixed to the pelvic wall, prostate, or bladder
  No tumors that can be locally excised in the surgeon's opinion

No clinically documented synchronous, distant metastases
No hereditary non polyposis colorectal cancer or familial adenomatosis

Prior/Concurrent Therapy:

Biologic therapy:
  No prior immunotherapy

  No prior chemotherapy

Endocrine therapy:
  Not specified

  No prior radiotherapy to the pelvis

  No prior partial resection or left-sided large bowel and/or rectum
  No prior multiple and/or pelvic surgical procedures
  No emergency surgery

Patient Characteristics:

  18 and over

Performance status:
  WHO 0-2

  Not specified

  Not specified

  Not specified

  No second malignancy except adequately treated:
     Basal cell skin cancer
     Carcinoma in situ of the cervix
  Able to complete follow-up

Expected Enrollment

A total of 1,400 patients will be accrued for this study over 3 years.


This is a randomized, multicenter study. Patients are stratified according to 
center and expected resection type (low anterior resection vs abdominoperineal 
resection). Patients are randomized to one of two treatment arms.

Arm I:  Patients undergo abdominoperineal or low anterior resection. Some 
patients also receive radiotherapy 5 days a week for 5.5 weeks following 

Arm II: Patient receive radiotherapy for 5 days followed by surgery.

Patients are followed every 3 months for 1 year, then annually for 2 years.

Published Results

Kapiteijn E, Kranenbarg EK, Steup WH, et al.: Total mesorectal excision (TME) with or without preoperative radiotherapy in the treatment of primary rectal cancer. Prospective randomised trial with standard operative and histopathological techniques. Dutch ColoRectal Cancer Group. Eur J Surg 165 (5): 410-20, 1999.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Leiden University Medical Center

Cornelis van de Velde, MD, PhD, FRCS, FRCPS, Protocol chair
Ph: 31-71-526-2309

European Organization for Research and Treatment of Cancer

Bernard Nordlinger, MD, Protocol chair
Ph: 33-14-90-95-586

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.