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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

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ClinicalTrials.gov Identifier: NCT00227747
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2005
Last Update Posted : April 15, 2010
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: capecitabine Drug: oxaliplatin Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 590 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Rate of complete surgical resection

Secondary Outcome Measures :
  1. Overall survival
  2. Disease-free survival
  3. Sphincter preservation
  4. Sphincter function
  5. Biological parameters that predict tumor response and treatment-related toxicity
  6. Acute and late toxicity

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227747


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Sponsors and Collaborators
UNICANCER
Investigators
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Study Chair: Jean-Pierre Gerard, MD Centre Antoine Lacassagne
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00227747     History of Changes
Other Study ID Numbers: CDR0000445034
FRE-FNCLCC-ACCORD-12/0405
EU-20522
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: April 15, 2010
Last Verified: December 2006
Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the rectum
stage II rectal cancer
stage III rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents