Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-04-06 @ 5:04 PM
Study NCT ID:
NCT00268333
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2005-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
Study Overview
Official Title:
Phase II Study of Recurrent Ganglionic Colorectal Cancer Not Accessible By Surgery Treated Using Chemotherapy With Simplified FOLFOX7 Followed By Radiotherapy Combined With 5FU and Oxaliplatin
Status:
COMPLETED
Status Verified Date:
2007-05
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, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the response rate in patients with recurrent metastatic colorectal cancer treated with neoadjuvant oxaliplatin, fluorouracil, and leucovorin calcium followed by radiotherapy and concurrent fluorouracil and oxaliplatin.
Secondary
* Determine the overall survival and disease-free survival of patients treated with this regimen.
* Determine the primary site of recurrence and time to recurrence in patients treated with this regimen.
* Determine quality of life of patients treated with this regimen.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
* Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Two to 5 weeks later, patients with stable or responding disease proceed to chemoradiotherapy.
* Chemoradiotherapy: Patients receive fluorouracil IV continuously 5 days a week for 5 weeks and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy 5 days a week for 5 weeks beginning on day 1.
Quality of life is assessed at baseline, 1 week after the completion of neoadjuvant chemotherapy, on days 15, 30, and 42 of chemoradiotherapy, and at 1 and 2 months after the completion of study treatment.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Primary
* Determine the response rate in patients with recurrent metastatic colorectal cancer treated with neoadjuvant oxaliplatin, fluorouracil, and leucovorin calcium followed by radiotherapy and concurrent fluorouracil and oxaliplatin.
Secondary
* Determine the overall survival and disease-free survival of patients treated with this regimen.
* Determine the primary site of recurrence and time to recurrence in patients treated with this regimen.
* Determine quality of life of patients treated with this regimen.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
* Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Two to 5 weeks later, patients with stable or responding disease proceed to chemoradiotherapy.
* Chemoradiotherapy: Patients receive fluorouracil IV continuously 5 days a week for 5 weeks and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy 5 days a week for 5 weeks beginning on day 1.
Quality of life is assessed at baseline, 1 week after the completion of neoadjuvant chemotherapy, on days 15, 30, and 42 of chemoradiotherapy, and at 1 and 2 months after the completion of study treatment.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
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?: