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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01086618
First received: March 12, 2010
Last updated: August 23, 2013
Last verified: March 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Accrual rate in months 10 to 12 (phase II) [ Designated as safety issue: No ]
  • Overall survival for ≥ 2 years (phase III) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity of surgery (phase II) [ Designated as safety issue: No ]
  • Percentage of patients who receive chemotherapy following surgery (must be over 80%) (phase II) [ Designated as safety issue: No ]
  • Morbidity of chemotherapy and surgery (phase III) [ Designated as safety issue: No ]
  • Quality of life (phase III) [ Designated as safety issue: No ]
  • Economic evaluation (phase III) [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2010
Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086618

Locations
United Kingdom
University College Hospital
London, England, United Kingdom, NW1 2BU
Sponsors and Collaborators
University College London Hospitals
Investigators
Principal Investigator: Austin Obichere, MD University College London Hospitals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01086618     History of Changes
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
Study First Received: March 12, 2010
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer

Additional relevant 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

ClinicalTrials.gov processed this record on July 28, 2014