Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-28 @ 12:33 PM
Study NCT ID:
NCT00006256
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2000-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan 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:
True
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?: