Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: systemic chemotherapy Procedure: adjuvant therapy Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery Phase 2 Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease
Study Start Date : January 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Accrual rate in months 10 to 12 (phase II)
  2. Overall survival for ≥ 2 years (phase III)

Secondary Outcome Measures :
  1. Morbidity of surgery (phase II)
  2. Percentage of patients who receive chemotherapy following surgery (must be over 80%) (phase II)
  3. Morbidity of chemotherapy and surgery (phase III)
  4. Quality of life (phase III)
  5. Economic evaluation (phase III)

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086618


Locations
Layout table for location information
United Kingdom
University College Hospital
London, England, United Kingdom, NW1 2BU
Sponsors and Collaborators
University College London Hospitals
Investigators
Layout table for investigator information
Principal Investigator: Austin Obichere, MD University College London Hospitals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: 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
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: March 2010
Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases