Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

UNICANCER

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18-80 years

Phase:

PHASE3

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, ei...

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 th...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 8 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    July 15 2013

    Estimated Enrollment :

    598 Patients enrolled

    Trial Details

    Trial ID

    NCT00227747

    Start Date

    November 8 2005

    End Date

    July 15 2013

    Last Update

    February 17 2021

    Active Locations (69)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 18 (69 locations)

    1

    Centre Hospitalier d'Abbeville

    Abbeville, France, 80101

    2

    Centre Hospitalier

    Altkirch, France, 68134

    3

    Institut Sainte Catherine

    Avignon, France, 84000

    4

    Hopital Duffaut

    Avignon, France, 84902