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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01086618
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 12, 2010
First Posted Date  ICMJE March 15, 2010
Last Update Posted Date August 26, 2013
Study Start Date  ICMJE January 2010
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
  • Accrual rate in months 10 to 12 (phase II)
  • Overall survival for ≥ 2 years (phase III)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy With or Without Surgery in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: systemic chemotherapy
  • Procedure: adjuvant therapy
  • Procedure: quality-of-life assessment
  • Procedure: therapeutic conventional surgery
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 12, 2010)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01086618
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University College London Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Austin Obichere, MD University College London Hospitals
PRS Account National Cancer Institute (NCI)
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP