Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093379
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2004-10-06
Brief Title:
Capecitabine Oxaliplatin and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Capecitabine XelodaOxaliplatin Eloxatin With Concomitant Radiotherapy XRT XELOXRT in Squamous Cell Carcinoma of the Anal Canal
Status:
COMPLETED
Status Verified Date:
2023-03
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 such as capecitabine and oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die Capecitabine may stop the growth of tumor cells by stopping blood flow to the tumor Radiation therapy uses high-energy x-rays to damage tumor cells Capecitabine and oxaliplatin may make tumor cells more sensitive to radiation therapy Combining capecitabine and oxaliplatin with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with stage II or stage III anal cancer
PURPOSE This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with stage II or stage III anal cancer
Detailed Description:
OBJECTIVES
Primary
Determine time to treatment failure in patients with stage II-IIIB squamous cell carcinoma of the anal canal treated with capecitabine oxaliplatin and radiotherapy ie Capecitabine XelodaOxaliplatin Eloxatin With Concomitant Radiotherapy XRT shortened to XELOXXRT
Determine the toxic effects of this regimen in these patients
Secondary
Determine the complete response rate in patients treated with this regimen
Determine 2-year local regional control in patients treated with this regimen
Determine 2-year colostomy-free survival in patients treated with this regimen
Determine 2-year median overall survival in patients treated with this regimen
Determine 2-year progression-free survival in patients treated with this regimen
OUTLINE Patients receive oral capecitabine twice daily on days 1-2 6-10 20-24 27-31 and 41-42 and undergo radiotherapy once daily on days 1-3 6-10 13-17 20-24 27-31 34-38 and 41-42 Patients also receive oxaliplatin intravenous IV over 2 hours on days 1 8 22 and 29 Treatment continues in the absence of disease progression or unacceptable toxicity
NOTE Patients with T3-4 lesions also receive oral capecitabine twice daily and undergo radiotherapy once daily on days 43 and 44
Patients are followed at 4-6 and 12 weeks and then periodically thereafter
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study
Primary
Determine time to treatment failure in patients with stage II-IIIB squamous cell carcinoma of the anal canal treated with capecitabine oxaliplatin and radiotherapy ie Capecitabine XelodaOxaliplatin Eloxatin With Concomitant Radiotherapy XRT shortened to XELOXXRT
Determine the toxic effects of this regimen in these patients
Secondary
Determine the complete response rate in patients treated with this regimen
Determine 2-year local regional control in patients treated with this regimen
Determine 2-year colostomy-free survival in patients treated with this regimen
Determine 2-year median overall survival in patients treated with this regimen
Determine 2-year progression-free survival in patients treated with this regimen
OUTLINE Patients receive oral capecitabine twice daily on days 1-2 6-10 20-24 27-31 and 41-42 and undergo radiotherapy once daily on days 1-3 6-10 13-17 20-24 27-31 34-38 and 41-42 Patients also receive oxaliplatin intravenous IV over 2 hours on days 1 8 22 and 29 Treatment continues in the absence of disease progression or unacceptable toxicity
NOTE Patients with T3-4 lesions also receive oral capecitabine twice daily and undergo radiotherapy once daily on days 43 and 44
Patients are followed at 4-6 and 12 weeks and then periodically thereafter
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000380771 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-2003-0874 | OTHER | None | None |
| SANOFI-MDA-2003-0874 | None | None | None |