Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006256
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2000-09-11
Brief Title:
Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Concurrent Taxol Paclitaxel and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of AdriamycinCytoxan Chemotherapy
Status:
COMPLETED
Status Verified Date:
2023-11
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 use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining paclitaxel with radiation therapy may kill more tumor cells
PURPOSE This trial is to study the effectiveness of concurrent administration of chemotherapy and radiation therapy in treating women who have stage II or stage III breast cancer by examining the complications and cosmetic effects
PURPOSE This trial is to study the effectiveness of concurrent administration of chemotherapy and radiation therapy in treating women who have stage II or stage III breast cancer by examining the complications and cosmetic effects
Detailed Description:
OBJECTIVES
Determine the feasibility of concurrent paclitaxel and breast radiotherapy in women with stage II or III breast cancer who have had primary breast conserving surgery and adjuvant chemotherapy
Assess the cosmetic results of breast conservation after this treatment in these patients
Determine the pulmonary toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month every 3 months for 1 year every 6 months for the next 5 years and then annually thereafter
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study over 12-18 months
Determine the feasibility of concurrent paclitaxel and breast radiotherapy in women with stage II or III breast cancer who have had primary breast conserving surgery and adjuvant chemotherapy
Assess the cosmetic results of breast conservation after this treatment in these patients
Determine the pulmonary toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month every 3 months for 1 year every 6 months for the next 5 years and then annually thereafter
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study over 12-18 months
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