Chemotherapy With or Without Surgery in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

Study Overview
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Brief Summary
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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
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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

Official Title
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A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: systemic chemotherapy
* Procedure: adjuvant therapy
* Procedure: quality-of-life assessment
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: systemic chemotherapy|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: quality-of-life assessment|nan|
|Procedure: therapeutic conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual rate in months 10 to 12 (phase II) |  |  | 
| Overall survival for ≥ 2 years (phase III) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV colon cancer, stage IV rectal cancer