A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease
18 Years
N/A
Both
Colorectal Cancer
Trial Information
A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease
OBJECTIVES:
- To determine whether overall survival is improved in patients with asymptomatic,
unresectable metastatic colorectal cancer treated with chemotherapy alone versus
surgery followed by chemotherapy.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (control arm): Patients receive systemic chemotherapy according to standard local
practice. Patients who develop symptoms from their primary tumor receive treatment as
required including surgery, if indicated.
- Arm II (experimental arm): Patients undergo surgery at the discretion of the surgeon.
Beginning 8 weeks after completion of surgery, patients receive chemotherapy according
to standard local practice.
Patients complete quality-of-life questionnaires (EQ-5D) at baseline and then periodically
during and after completion of study treatment.
After completion of study treatment, patients are followed every 3 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed colorectal cancer
- Metastases which are unresectable at presentation
- No known unresectable primary tumor on CT/MRI scan
- Primary tumor does not require immediate or emergency intervention including surgery,
radiotherapy, laser, or stenting
- Patients who are treated with colonic stents are eligible
- No unequivocal extensive peritoneal metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Must be fit for systemic chemotherapy and surgery
- Hemoglobin > 10.0 g/dL
- WBC > 3.0 x 10^9/L
- Platelet count > 100 x 10^9/L
- Bilirubin < 25 μmol/L
- GFR > 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months (female) or
up to 2 months (male) after completion of study therapy
- No history of malignant disease within the past 5 years except for nonmelanomatous
skin cancer or carcinoma in situ of the cervix
- No serious medical co-morbidity (e.g., uncontrolled inflammatory bowel disease,
uncontrolled angina, recent [within the past 6 months] myocardial infarction, or
another serious medical condition) judged to compromise ability to tolerate
chemotherapy and/or surgery
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent participation in a trial of chemotherapy, if eligible, allowed
- Concurrent short-course radiotherapy for operable rectal cancer allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Accrual rate in months 10 to 12 (phase II)
Safety Issue:
No
Principal Investigator
Austin Obichere, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University College London Hospitals
Authority:
Unspecified
Study ID:
CDR0000667364
NCT ID:
NCT01086618
Start Date:
January 2010
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage IV colon cancer
- stage IV rectal cancer
- Colorectal Neoplasms
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