Back to resultsChemotherapy With or Without Surgery in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
systemic chemotherapy
adjuvant therapy
quality-of-life assessment
therapeutic conventional surgery
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer
Eligibility 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
Sites / Locations
- University College Hospital
Outcomes
Primary Outcome Measures
Accrual rate in months 10 to 12 (phase II)
Overall survival for ≥ 2 years (phase III)
Secondary Outcome Measures
Morbidity of surgery (phase II)
Percentage of patients who receive chemotherapy following surgery (must be over 80%) (phase II)
Morbidity of chemotherapy and surgery (phase III)
Quality of life (phase III)
Economic evaluation (phase III)
Full Information
NCT ID
NCT01086618
First Posted
March 12, 2010
Last Updated
August 23, 2013
Sponsor
University College London Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT01086618
Brief Title
Chemotherapy With or Without Surgery in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
Official Title
A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University College London Hospitals
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given alone or together with surgery in treating patients with colorectal cancer.
PURPOSE: This randomized phase II/III trial is studying how well chemotherapy works and compares it with surgery followed by chemotherapy in treating patients with metastatic colorectal cancer that can not be removed by surgery.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
systemic chemotherapy
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Primary Outcome Measure Information:
Title
Accrual rate in months 10 to 12 (phase II)
Title
Overall survival for ≥ 2 years (phase III)
Secondary Outcome Measure Information:
Title
Morbidity of surgery (phase II)
Title
Percentage of patients who receive chemotherapy following surgery (must be over 80%) (phase II)
Title
Morbidity of chemotherapy and surgery (phase III)
Title
Quality of life (phase III)
Title
Economic evaluation (phase III)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Austin Obichere, MD
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Hospital
City
London
State/Province
England
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Chemotherapy With or Without Surgery in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
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