Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003596
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Randomized Study of 5-Fluorouracil Mitomycin-C and Radiotherapy Versus 5-Fluorouracil Cisplatin and Radiotherapy in Carcinoma of the Anal Canal
Status:
COMPLETED
Status Verified Date:
2016-12
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug or combining radiation therapy with chemotherapy may kill more tumor cells It is not yet known whether fluorouracil and mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus radiation therapy for anal cancer
PURPOSE This randomized phase III trial is studying fluorouracil and mitomycin plus radiation therapy to see how well it works compared to fluorouracil and cisplatin plus radiation therapy in treating patients with stage II or stage III anal cancer
PURPOSE This randomized phase III trial is studying fluorouracil and mitomycin plus radiation therapy to see how well it works compared to fluorouracil and cisplatin plus radiation therapy in treating patients with stage II or stage III anal cancer
Detailed Description:
OBJECTIVES
Compare the initial and total local and distant failure rates in patients with anal canal cancer treated with either fluorouracil 5-FU plus mitomycin concurrently with radiotherapy or 5-FU plus cisplatin followed by 5-FU plus cisplatin concurrently with radiotherapy
Identify any differences in local control and colostomy rates at 2 years in patients treated with these regimens
Determine any difference in colostomy free disease free or overall survival in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Evaluate the prognostic effects of tumor markers P53 overexpression human papilloma virus status and enzyme HAP1 in patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to gender nodal status positive vs negative and primary tumor size greater than 2 cm to 5 cm vs greater than 5 cm Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fluorouracil 5-FU IV continuously over 96 hours beginning on days 1 and 29 and mitomycin IV on days 1 and 29 with concurrent radiotherapy
Arm II Patients receive induction chemotherapy comprising 5-FU IV continuously over 96 hours beginning on days 1 29 57 and 85 and cisplatin IV over 1 hour on days 1 29 57 and 85 Beginning on day 57 patients receive concurrent radiotherapy
In both arms radiotherapy is administered daily 5 days a week for 5-65 weeks Patients with T3 T4 or N lesions or T2 lesions with residual disease receive additional radiotherapy to a reduced field
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 650 patients will be accrued for this study within 5 years
Compare the initial and total local and distant failure rates in patients with anal canal cancer treated with either fluorouracil 5-FU plus mitomycin concurrently with radiotherapy or 5-FU plus cisplatin followed by 5-FU plus cisplatin concurrently with radiotherapy
Identify any differences in local control and colostomy rates at 2 years in patients treated with these regimens
Determine any difference in colostomy free disease free or overall survival in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Evaluate the prognostic effects of tumor markers P53 overexpression human papilloma virus status and enzyme HAP1 in patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to gender nodal status positive vs negative and primary tumor size greater than 2 cm to 5 cm vs greater than 5 cm Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fluorouracil 5-FU IV continuously over 96 hours beginning on days 1 and 29 and mitomycin IV on days 1 and 29 with concurrent radiotherapy
Arm II Patients receive induction chemotherapy comprising 5-FU IV continuously over 96 hours beginning on days 1 29 57 and 85 and cisplatin IV over 1 hour on days 1 29 57 and 85 Beginning on day 57 patients receive concurrent radiotherapy
In both arms radiotherapy is administered daily 5 days a week for 5-65 weeks Patients with T3 T4 or N lesions or T2 lesions with residual disease receive additional radiotherapy to a reduced field
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 650 patients will be accrued for this study within 5 years
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 |
|---|---|---|---|
| GUMC-00125 | None | None | None |
| CDR0000066667 | None | None | None |
| CALGB-89808 | None | None | None |
| ECOG-R9811 | None | None | None |
| NCCTG-R9811 | None | None | None |
| SWOG-R9811 | None | None | None |