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

• ClinicalTrials.gov Identifier: NCT01086618
• Recruitment Status: Completed
• First Posted: March 15, 2010
• Last Update Posted: August 26, 2013
• Sponsor: University College London Hospitals
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: March 12, 2010
• First Posted Date: March 15, 2010
• Last Update Posted Date: August 26, 2013
• Study Start Date: January 2010
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 12, 2010)

• Accrual rate in months 10 to 12 (phase II)
• Overall survival for ≥ 2 years (phase III)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 12, 2010)

• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Primary Purpose: Treatment
• Condition: Colorectal Cancer

Intervention

• Drug: systemic chemotherapy
• Procedure: adjuvant therapy
• Procedure: quality-of-life assessment
• Procedure: therapeutic conventional surgery

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: March 12, 2010): 500
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01086618
• Other Study ID Numbers: CDR0000667364; UCL-08/0079; UCL-ISAAC; ISRCTN10963271; EU-21008; CRUK-C32436/A10431; EUDRACT-2008-005911-16; MREC-09/H1102/60; NCRI-UCL-08/0079
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: University College London Hospitals
• Collaborators: Not Provided

Investigators

• Principal Investigator: Austin Obichere, MD; University College London Hospitals

• PRS Account: National Cancer Institute (NCI)
• Verification Date: March 2010