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Combination Chemotherapy After Surgery in Treating Patients With High-Risk Stage II or Stage III Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Cancer Research UK, Glasgow.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Laura Alexander, Cancer Research UK, Glasgow
ClinicalTrials.gov Identifier:
NCT00749450
First received: September 6, 2008
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have undergone surgery for high-risk colorectal cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy given after surgery in treating patients with high-risk stage II or stage III colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: capecitabine
Drug: fluorouracil
Drug: oxaliplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short Course Oncology Therapy - A Study of Adjuvant Chemotherapy in Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Cancer Research UK, Glasgow:

Primary Outcome Measures:
  • 3-year disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: assessed during 5 year recruitment period and maximum 7 year follow up period ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: assessed during 5 year recruitment period ] [ Designated as safety issue: No ]
  • Toxicity according to NCI CTCAE Version 3.0 [ Time Frame: assessed during 5 year recruitment period ] [ Designated as safety issue: Yes ]
  • Quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-CR29, EQ-5D, and GOG Ntx4 [ Time Frame: assessed during 5 year recruitment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 9500
Study Start Date: March 2008
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive OxMdG or XELOX combination chemotherapy for a total of 12 courses for treatment lasting a total of 24 weeks.
Drug: capecitabine
Given orally
Drug: fluorouracil
Given IV
Drug: oxaliplatin
Given IV
Experimental: Arm II
Patients receive OxMdG or XELOX combination chemotherapy for a total of 6 courses for treatment lasting a total of 12 weeks.
Drug: capecitabine
Given orally
Drug: fluorouracil
Given IV
Drug: oxaliplatin
Given IV

Detailed Description:

OBJECTIVES:

  • To assess the efficacy and compare the associated toxicity of adjuvant chemotherapy lasting 12 weeks vs 24 weeks in patients with fully resected high-risk stage II or III colorectal cancer.
  • To conduct an economic analysis of the cost effectiveness of these regimens.
  • To compare the randomization methodologies used in this study.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center's recruitment potential. Patients are randomized (within 10 weeks after surgery and before or after receiving 12 weeks of chemotherapy) to 1 of 2 treatment arms. The treatment regimen that a patient receives (Oxaliplatin Modified DeGramont [OxMdG] or XELOX) is determined by the participating center.

  • Arm I: Patients receive 12 courses of OxMdG (described below) or XELOX (described below)combination chemotherapy (6 additional courses if patient already received 6 courses) for treatment lasting a total of 24 weeks.
  • Arm II: Patients receive 6 courses of OxMdG or XELOX combination chemotherapy (no additional courses if patient already received 6 courses) for treatment lasting a total of 12 weeks.

The two adjuvant combination chemotherapy regimens are administered as follows:

  • OxMdG: Patients receive oxaliplatin IV over 2 hours and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • XELOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life assessments periodically using the EORTC QLQ-C30, EORTC QLQ-CR29, EQ-5D, and GOG Ntx4 questionnaires.

After completion of study treatment, patients are followed periodically for up to 7 years.

Peer Reviewed and Funded by Medical Research Council (MRC)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of colorectal cancer meeting 1 of the following criteria:

    • High-risk stage IIB disease, defined as T4 disease, perforation, obstruction, < 10 nodes examined, poorly differentiated histology, extramural venous invasion, or extramural lymphatic invasion
    • Fully resected stage III disease
  • Patients with rectal cancer must meet the following criteria:

    • Underwent prior total mesorectal excision surgery with negative resection (R0) margins
    • No prior pre-operative or scheduled post-operative combined chemotherapy and radiotherapy
  • No evidence of residual or metastatic disease
  • Deemed suitable for adjuvant chemotherapy

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Life expectancy > 5 years with reference to noncancer-related diseases
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Carcinoembryonic antigen (CEA) levels normal
  • Glomerular filtration rate ≥ 30 mL/min (no moderate or severe renal impairment)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must effective contraception
  • More than 12 months since prior and no active clinically significant cardiovascular disease, including any of the following:

    • Cerebrovascular accident
    • Myocardial infarction
    • Unstable angina
    • New York Heart Association class II-IV congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)
  • Disease-free interval of ≥ 5 years for previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal cell or squamous cell carcinoma of the skin
  • No known or suspected dihydropyrimidine dehydrogenase deficiency

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 10 weeks since prior surgery and recovered
  • No prior chemotherapy (except in patients randomized after 12 weeks of adjuvant therapy)
  • No prior abdomino-pelvic radiotherapy, with the exception of short-course pre-operative radiotherapy for rectal cancer
  • No concurrent brivudine or sorivudine for patients taking capecitabine
  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 ClinicalTrials.gov identifier: NCT00749450

Locations
United Kingdom
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Scotland, United Kingdom, G12 0YN
Contact: Tim Iveson, FRCP, MD, MRCP, MBBS, BSC    02380796802    tiveson@doctors.org.uk   
Sponsors and Collaborators
Cancer Research UK, Glasgow
Investigators
Principal Investigator: Tim Iveson, FRCP, MD, MRCP, MBBS, BSC University Hospital Southampton NHS Foundation Trust.
  More Information

Additional Information:
No publications provided

Responsible Party: Laura Alexander, Project Manager, Cancer Research UK, Glasgow
ClinicalTrials.gov Identifier: NCT00749450     History of Changes
Other Study ID Numbers: CDR0000613042, CRUK-SCOT, ISRCTN59757862, EudraCT 2007-003957-10, EU-20874, SCOT-2007-01
Study First Received: September 6, 2008
Last Updated: April 23, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cancer Research UK, Glasgow:
stage II colon cancer
stage III colon cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014