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

NCT01086618 | Completed Phase 2

• 9 other identifiers: CDR0000667364UCL-08/0079UCL-ISAACISRCTN10963271EU-21008CRUK-C32436/A10431EUDRACT-2008-005911-16MREC-09/H1102/60NCRI-UCL-08/0079
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (2)

• Accrual rate in months 10 to 12 (phase II)

• Overall survival for ≥ 2 years (phase III)

Secondary Outcomes (5)

• 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)

Interventions

systemic chemotherapy DRUG

adjuvant therapy PROCEDURE

quality-of-life assessment PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (1)

University College Hospital

London, England, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Neoadjuvant Therapy; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Austin Obichere, MD

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 15, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2010-03

Locations

GB (1)