Ignite Creation Date:
2025-12-18 @ 3:58 AM
Ignite Modification Date:
2025-12-18 @ 3:58 AM
Study NCT ID:
NCT00725400
Status:
None
Last Update Posted:
2011-07-20 00:00:00
First Post:
2008-07-28 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of Cetuximab and Radiation Vs Surgery Before or After Radiation in Patients With Colorectal Carcinoma
Sponsor:
None
Organization:
Study Overview
Official Title:
Phase II Open Label Comparative Study of Cetuximab and Radiation Therapy Vs Surgery Before or After Radiation Therapy in Patients With Stage II to IV Colorectal Carcinoma
Status:
None
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study is withdrawn due to unavailability of eligible subject population. We will request the sponsors to extend the time for enrollment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES:
Primary:
* Determine the response rate in patients with Colorectal Cancer treated with Cetuximab and Radiation Therapy Vs Surgery before or after Radiation Therapy.
Secondary:
* To determine the progression-free survival and overall survival of patients treated with these regimens.
* Compare the treatment compliance of patients treated with these regimens.
* Compare the safety of these regimens in these patients.
OUTLINE: This is an Open-label, Controlled, Multicenter study. Patients will be assigned into two different Arms.
Arm I: Patients will receive Cetuximab and Radiation Therapy. Patients will receive a dose of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
Arm II: Patients will undergo surgery before or after Radiation Therapy. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
PROJECTED ACCRUAL: Approximately 450 patients will be accrued for this study within 18 to 24 months.
Primary:
* Determine the response rate in patients with Colorectal Cancer treated with Cetuximab and Radiation Therapy Vs Surgery before or after Radiation Therapy.
Secondary:
* To determine the progression-free survival and overall survival of patients treated with these regimens.
* Compare the treatment compliance of patients treated with these regimens.
* Compare the safety of these regimens in these patients.
OUTLINE: This is an Open-label, Controlled, Multicenter study. Patients will be assigned into two different Arms.
Arm I: Patients will receive Cetuximab and Radiation Therapy. Patients will receive a dose of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
Arm II: Patients will undergo surgery before or after Radiation Therapy. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.
PROJECTED ACCRUAL: Approximately 450 patients will be accrued for this study within 18 to 24 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: