Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT01086618
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2010-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemotherapy With or Without Surgery in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
Sponsor:
University College London Hospitals
Organization:
Study Overview
Official Title:
A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: