Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068744
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2003-09-10
Brief Title:
Radiation Therapy Mitomycin and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Continuous Fluorouracil Plus Mitomycin C Versus Mitomycin C Plus Cisplatin As Chemotherapy Combination In Combined Radiochemotherapy For Locally Advanced Anal Cancer A Phase II-III Study
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 mitomycin fluorouracil and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells It is not yet known whether radiation therapy and mitomycin are more effective when combined with fluorouracil or with cisplatin in treating anal cancer
PURPOSE This randomized phase IIIII trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy mitomycin and cisplatin in treating patients with locally advanced anal cancer
PURPOSE This randomized phase IIIII trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy mitomycin and cisplatin in treating patients with locally advanced anal cancer
Detailed Description:
OBJECTIVES
Phase II
Primary
Compare the early clinical response tumor response at 8 weeks of patients with locally advanced anal cancer treated with radiotherapy with mitomycin and cisplatin vs mitomycin and fluorouracil
Secondary
Compare the feasibility of these regimens in these patients
Compare the acute toxicity of these regimens in these patients
Compare patient compliance to these regimens
Phase III
Primary
Compare the event-free survival of patients treated with these regimens
Secondary
Compare colostomy-free disease-free and overall survival of patients treated with these regimens
Compare locoregional control in patients treated with these regimens
Compare the late toxicity of these regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center T stage T2 vs T3 vs T4 and nodal status N0 vs N Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily 5 days a week on weeks 1-4 7-8 and 3 days of week 9 total of 33 fractions Patients concurrently receive fluorouracil IV continuously on days 1-26 and 43-59 and mitomycin IV over 15 minutes on days 1 and 43
Arm II Patients receive radiotherapy and mitomycin as in arm I and cisplatin IV over 1 hour on days 1 8 15 22 43 50 and 57
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at weeks 12 and 26 and then every 6 months for 2 years
Patients are followed every 2 weeks for 8 weeks at week 26 and then every 6 months thereafter
PROJECTED ACCRUAL A total of 678 patients 80 40 per treatment arm for phase II and 598 299 per treatment arm for phase III will be accrued for this study within 2-5 years
Phase II
Primary
Compare the early clinical response tumor response at 8 weeks of patients with locally advanced anal cancer treated with radiotherapy with mitomycin and cisplatin vs mitomycin and fluorouracil
Secondary
Compare the feasibility of these regimens in these patients
Compare the acute toxicity of these regimens in these patients
Compare patient compliance to these regimens
Phase III
Primary
Compare the event-free survival of patients treated with these regimens
Secondary
Compare colostomy-free disease-free and overall survival of patients treated with these regimens
Compare locoregional control in patients treated with these regimens
Compare the late toxicity of these regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center T stage T2 vs T3 vs T4 and nodal status N0 vs N Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily 5 days a week on weeks 1-4 7-8 and 3 days of week 9 total of 33 fractions Patients concurrently receive fluorouracil IV continuously on days 1-26 and 43-59 and mitomycin IV over 15 minutes on days 1 and 43
Arm II Patients receive radiotherapy and mitomycin as in arm I and cisplatin IV over 1 hour on days 1 8 15 22 43 50 and 57
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at weeks 12 and 26 and then every 6 months for 2 years
Patients are followed every 2 weeks for 8 weeks at week 26 and then every 6 months thereafter
PROJECTED ACCRUAL A total of 678 patients 80 40 per treatment arm for phase II and 598 299 per treatment arm for phase III will be accrued for this study within 2-5 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 |
|---|---|---|---|
| EORTC-40014 | None | None | None |
| EORTC-22011 | None | None | None |