Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over		DUT-KWF-CKVO-9504 EORTC-40971, EU-96020

Objectives

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
polyposis

Prior/Concurrent Therapy:

Biologic therapy:
  No prior immunotherapy

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy to the pelvis

Surgery:
  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:

Age:
  18 and over

Performance status:
  WHO 0-2

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  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.

Outline

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 
surgery.

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.

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 Email: c.j.h.van_de_velde@lumc.nl

European Organization for Research and Treatment of Cancer

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

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