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Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00227747
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Tracking Information
First Submitted Date  ICMJE September 26, 2005
First Posted Date  ICMJE September 28, 2005
Last Update Posted Date February 17, 2021
Actual Study Start Date  ICMJE November 8, 2005
Actual Primary Completion Date October 22, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2007)
Rate of complete surgical resection
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2007)
  • Overall survival
  • Disease-free survival
  • Sphincter preservation
  • Sphincter function
  • Biological parameters that predict tumor response and treatment-related toxicity
  • Acute and late toxicity
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer
Official Title  ICMJE Randomized Phase III Trial Comparing in a Preoperative Schedule the Result of Two Concurrent Chemoradiation Schemes (45 Gy + Capecitabine vs 50 Gy + Capecitabine - Oxaliplatin) on the Rate of Sterilization of the Operative Specimen in Resectable Rectal Carcinomas T3-4 No-2 Mo
Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.

Detailed Description

OBJECTIVES:

Primary

  • Compare the efficacy of neoadjuvant chemoradiotherapy comprising radiotherapy and capecitabine with vs without oxaliplatin followed by total mesorectal excision, in terms of the rate of complete surgical resection, in patients with resectable stage II or III rectal cancer.

Secondary

  • Compare overall and disease-free survival of patients treated with these regimens.
  • Compare clinical tumor response in patients treated with these regimens.
  • Compare acute and late toxicity of these regimens in these patients.
  • Determine biological parameters that predict tumor response and treatment-related toxicity in patients treated with these regimens.
  • Compare sphincter preservation and function in patients treated with these regimens.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiotherapy once daily 5 days a week and receive capecitabine once daily 5 days a week in weeks 1-5.
  • Arm II: Patient undergo radiotherapy and receive capecitabine as in arm I. Patients also receive oxaliplatin once weekly in weeks 1-5.

All patients undergo total mesorectal excision 6 weeks after completion of chemoradiotherapy.

PROJECTED ACCRUAL: A total of 590 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: capecitabine
  • Drug: oxaliplatin
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
Study Arms  ICMJE
  • Experimental: Radiothérapie + Xelox
    Interventions:
    • Drug: capecitabine
    • Drug: oxaliplatin
    • Procedure: conventional surgery
    • Procedure: neoadjuvant therapy
    • Radiation: radiation therapy
  • Active Comparator: Radiothérapie + Capécitabine
    Interventions:
    • Drug: capecitabine
    • Procedure: conventional surgery
    • Procedure: neoadjuvant therapy
    • Radiation: radiation therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 15, 2021)
598
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 15, 2013
Actual Primary Completion Date October 22, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the rectum

    • T3-4, N0-2, M0 disease by endorectal ultrasound

      • T2 disease located in the low rectum allowed provided lower pole is ≤ 6 cm from the anal verge
  • Tumor must be accessible to digital rectal examination (i.e., tumor located at low- or mid-rectum)
  • Resectable disease treatable with chemoradiotherapy

    • No unresectable disease (i.e., T4 disease with high risk for incomplete gross resection [i.e., R2])

PATIENT CHARACTERISTICS:

Age

  • 18 to 80

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin > 10 g/dL

Hepatic

  • Alkaline phosphatase normal
  • Bilirubin normal

Renal

  • Creatinine ≤ 130 μmol/L
  • No severe renal insufficiency

Cardiovascular

  • No cardiac insufficiency
  • No symptomatic coronary artery disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No contraindication to study treatment
  • Prior acute intestinal obstruction allowed provided patient underwent surgical diversion with stoma
  • No history of other cancer except basal cell skin cancer or carcinoma in situ of the cervix
  • No peripheral neuropathy
  • No uncontrolled diabetes
  • No other uncontrolled severe disease
  • No geographical, social, or psychological condition that would preclude study follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for cancer
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy for cancer

Surgery

  • Not specified

Other

  • No concurrent phenytoin
  • No concurrent participation in another clinical trial of an experimental medical treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00227747
Other Study ID Numbers  ICMJE CDR0000445034
FRE-FNCLCC-ACCORD-12/0405
EU-20522
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party UNICANCER
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE UNICANCER
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jean-Pierre Gerard, MD Centre Antoine Lacassagne
PRS Account UNICANCER
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP