Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003893
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer
Sponsor:
University Hospital Birmingham
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast Cancer
Status:
COMPLETED
Status Verified Date:
2001-11
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 work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumors cells Combining chemotherapy with radiation therapy may kill more tumor cells It is not yet known which regimen of chemotherapy plus radiation therapy is more effective for early-stage breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of adjuvant chemotherapy plus radiation therapy in treating women who have early-stage breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of adjuvant chemotherapy plus radiation therapy in treating women who have early-stage breast cancer
Detailed Description:
OBJECTIVES
Compare the effects of synchronous vs sequential adjuvant chemotherapy and radiotherapy on local recurrence disease-free and overall survival and treatment delay in women with early-stage breast cancer
Compare the safety of these regimens in terms of dose intensity and toxicity in this patient population
Compare the quality of life and cosmetic outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to clinical oncologist axillary clearance yes vs no radiotherapy boost intent boost vs no boost and chemotherapy intent cyclophosphamide methotrexate and fluorouracil 5-FU vs anthracycline-containing regimen Patients are randomized to one of two treatment arms
Patients receive any chemotherapy regimen that includes cyclophosphamide methotrexate and 5-FU Some regimens may also include epirubicin doxorubicin mitoxantrone andor mitomycin Chemotherapy repeats every 3 weeks for 4-8 courses
Arm I synchronous chemoradiotherapy Patients receiving synchronous therapy receive any of the above chemotherapy regimens plus daily radiotherapy between courses 2 and 3 OR courses 5 and 6 of chemotherapy Radiotherapy is administered for 3-5 weeks
Arm II sequential chemoradiotherapy Patients receiving sequential therapy receive any of the above chemotherapy regimens followed by daily radiotherapy beginning after completion of all chemotherapy after course 6 or 8 Radiotherapy is administered for 3-5 weeks
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before chemotherapy 2-3 weeks after the completion of all treatment and then at 1 2 and 5 years
Patients are followed annually for 10 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 2250 patients 1125 per treatment arm will be accrued for this study
Compare the effects of synchronous vs sequential adjuvant chemotherapy and radiotherapy on local recurrence disease-free and overall survival and treatment delay in women with early-stage breast cancer
Compare the safety of these regimens in terms of dose intensity and toxicity in this patient population
Compare the quality of life and cosmetic outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to clinical oncologist axillary clearance yes vs no radiotherapy boost intent boost vs no boost and chemotherapy intent cyclophosphamide methotrexate and fluorouracil 5-FU vs anthracycline-containing regimen Patients are randomized to one of two treatment arms
Patients receive any chemotherapy regimen that includes cyclophosphamide methotrexate and 5-FU Some regimens may also include epirubicin doxorubicin mitoxantrone andor mitomycin Chemotherapy repeats every 3 weeks for 4-8 courses
Arm I synchronous chemoradiotherapy Patients receiving synchronous therapy receive any of the above chemotherapy regimens plus daily radiotherapy between courses 2 and 3 OR courses 5 and 6 of chemotherapy Radiotherapy is administered for 3-5 weeks
Arm II sequential chemoradiotherapy Patients receiving sequential therapy receive any of the above chemotherapy regimens followed by daily radiotherapy beginning after completion of all chemotherapy after course 6 or 8 Radiotherapy is administered for 3-5 weeks
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before chemotherapy 2-3 weeks after the completion of all treatment and then at 1 2 and 5 years
Patients are followed annually for 10 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 2250 patients 1125 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 |
|---|---|---|---|
| EU-99005 | None | None | None |
| CRC-TU-BR3015 | None | None | None |