Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025090
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2001-10-11
Brief Title:
Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer
Sponsor:
University College London UCL Cancer Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Second UK Phase III Anal Cancer Trial A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer
Status:
COMPLETED
Status Verified Date:
2007-03
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 Radiation therapy uses high-energy x-rays to kill tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with radiation therapy may kill more tumor cells It is not yet known if fluorouracil plus radiation therapy is more effective with or without additional chemotherapy in treating anal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil plus radiation therapy with or without additional chemotherapy in treating patients who have primary anal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil plus radiation therapy with or without additional chemotherapy in treating patients who have primary anal cancer
Detailed Description:
OBJECTIVES
Compare the response rates in patients with primary epidermoid anal cancer treated with radiotherapy and fluorouracil with either mitomycin or cisplatin and with or without maintenance therapy
Compare local control and prevention or delay of disease dissemination in patients treated with these regimens
OUTLINE This is randomized open-label multicenter study Patients are randomized to one of four treatment arms
All patients undergo radiotherapy daily 5 days a week for 55 weeks All patients also receive fluorouracil IV continuously over days 1-4 and 29-32
Arm I Patients receive mitomycin IV on day 1
Arm II Patients receive cisplatin IV on days 1 and 29
Arm III Patients receive mitomycin as in arm I and maintenance therapy comprising fluorouracil IV continuously over days 1-4 and cisplatin IV on day 1 beginning 4-8 weeks after completion of primary therapy and repeating once 3 weeks later
Arm IV Patients receive cisplatin as in arm II and maintenance therapy as in arm III
Patients are followed at 2 months every 3 months for 2 years every 6 months for 3 years and then annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 600 patients 150 per treatment arm will be accrued for this study
Compare the response rates in patients with primary epidermoid anal cancer treated with radiotherapy and fluorouracil with either mitomycin or cisplatin and with or without maintenance therapy
Compare local control and prevention or delay of disease dissemination in patients treated with these regimens
OUTLINE This is randomized open-label multicenter study Patients are randomized to one of four treatment arms
All patients undergo radiotherapy daily 5 days a week for 55 weeks All patients also receive fluorouracil IV continuously over days 1-4 and 29-32
Arm I Patients receive mitomycin IV on day 1
Arm II Patients receive cisplatin IV on days 1 and 29
Arm III Patients receive mitomycin as in arm I and maintenance therapy comprising fluorouracil IV continuously over days 1-4 and cisplatin IV on day 1 beginning 4-8 weeks after completion of primary therapy and repeating once 3 weeks later
Arm IV Patients receive cisplatin as in arm II and maintenance therapy as in arm III
Patients are followed at 2 months every 3 months for 2 years every 6 months for 3 years and then annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 600 patients 150 per treatment arm 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 |
|---|---|---|---|
| ISRCTN26715889 | None | None | None |
| NCRI-ACT-II | None | None | None |
| EU-20056 | None | None | None |
| UKCCCR-ACT-II | None | None | None |