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Radiation Therapy With or Without Chemotherapy Before Surgery in Treating Patients With Stage II or Stage III Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 24, 2006
Last updated: May 1, 2012
Last verified: April 2012

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without chemotherapy when given before surgery for rectal cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy given together with fluorouracil and leucovorin to see how well they work compared to giving radiation therapy alone before surgery in treating patients with stage II or stage III rectal cancer.

Condition Intervention Phase
Colorectal Cancer
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Preoperative Radiotherapy With or Without Concurrent Chemotherapy (5-Fluorouracil and Leucovorin) in T3-4 Rectal Cancers - Randomized Trial

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 762
Detailed Description:


  • Compare the recurrence-free and overall survival of patients with resectable stage II or III adenocarcinoma of the rectum treated with neoadjuvant radiotherapy with or without concurrent chemotherapy comprising fluorouracil and leucovorin calcium followed by surgery and adjuvant fluorouracil and leucovorin calcium.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, gender, location of the tumor relative to the anal margin (0-5 cm vs > 5 cm), and tumor stage (T3 vs T4). Patients are randomized to 1 of 2 treatment arms.

  • Neoadjuvant therapy: Patients are randomized to 1 of 2 neoadjuvant therapy arms.

    • Arm I: Patients receive leucovorin calcium IV and fluorouracil IV over 15 minutes on days 1-5. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent radiotherapy 5 days a week for 5 weeks.
    • Arm II: Patients undergo radiotherapy as in arm I.
  • Surgery: In both arms, patients undergo surgical resection within 3-10 weeks after completing neoadjuvant therapy.
  • Adjuvant therapy: Within 3-10 weeks after surgery, all patients receive adjuvant chemotherapy comprising leucovorin calcium IV and fluorouracil IV over 15 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for at least 5 years.

PROJECTED ACCRUAL: A total of 762 patients will be accrued for this study.


Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the rectum meeting 1 of the following stage criteria:

    • Stage T3, N0-2, M0 disease meeting 1 of the following criteria:

      • Invasive disease in entire circumference (circular tumor)
      • Tumor fixed laterally or posteriorly to pelvic structures
      • Tumor adherent to the prostate and/or seminal vesicles
      • Tumor infiltration into the vaginal-rectal septum
      • Tumor classified as uT3 by rectal endoscopy
    • Stage T4, N0-2, M0 disease meeting 1 of the following criteria:

      • Clinical or radiologic evidence of pelvic organ extension (vagina, prostate, seminal vesicles, or bladder)
      • Tumor extension to the anal canal or sphincter
      • Tumor classified as uT4 by rectal endoscopy
  • Tumor accessible by digital rectal exam
  • Resectable disease
  • No distant metastases


  • WHO performance status 0-1
  • Creatinine < 1.36 mg/dL
  • Granulocyte count > 2,000/mm^3
  • Platelet count > 130,000/mm^3
  • No progressive ischemic cardiomyopathy
  • No acute or chronic obstruction unless treated with diversion colostomy
  • No chronic inflammation of the ileum and/or colon
  • No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix


  • No prior chemotherapy, radiotherapy, or surgery for this cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00296608

Sponsors and Collaborators
Fondation Francaise de Cancerologie Digestive
Study Chair: Jean-Pierre Gerard, MD Centre Antoine Lacassagne
  More Information

Additional Information:
Methy N, Bedenne L, Gerard J, et al.: Surrogate endpoints in neoadjuvant rectal cancer trials: statistical evaluation using data from the FFCD 9203 trial. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-466, 2008.
Gerard J, Romestaing P, Bonnetain F, et al.: Preoperative chemotherapy (CT-RT) improves local control in T3-4 rectal cancers: results of the FFCD 9203 randomized trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-4, S2, 2005. Identifier: NCT00296608     History of Changes
Other Study ID Numbers: CDR0000466625, FFCD-9203, EU-20600
Study First Received: February 24, 2006
Last Updated: May 1, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II rectal cancer
stage III rectal cancer
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on November 25, 2014