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

Phase 2/Phase 3
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

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


- 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

Inclusion Criteria


- 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


- 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 ╬╝mol/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


- See Disease Characteristics

- Concurrent participation in a trial of chemotherapy, if eligible, allowed

- Concurrent short-course radiotherapy for operable rectal cancer allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Accrual rate in months 10 to 12 (phase II)

Safety Issue:


Principal Investigator

Austin Obichere, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University College London Hospitals



Study ID:




Start Date:

January 2010

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms