Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268333
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2005-12-20
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SANOFI-GERCOR-C04-1 | None | None | None |
| GERCOR-C04-1 | None | None | None |
| EU-20568 | None | None | None |