Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
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.
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy|
- Determine the feasibility of concurrent paclitaxel and breast radiotherapy [ Time Frame: Followed every 3 months for 1 year ] [ Designated as safety issue: Yes ]Ability to deliver appropriate doses of radiation therapy within the appropriate time course and calculate the chemotherapy dose achieved during concurrent Taxol and radiation therapy.
- Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor. [ Time Frame: 1 year ] [ Designated as safety issue: No ]These parameters will be assessed by medical and radiation oncology. We expect at least a > 60% completion rate with this treatment, which translates into confidence limits of 46% to 74% when 40 patients are investigated.
- Pulmonary function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Combined treatment impact on pulmonary function. Evidence of pulmonary toxicity demonstrated by a reduction in DLCO (Diffusing Capacity of the Lung for Carbon Monoxide).
- Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Patients followed for long term survival for at least 5 years.
|Study Start Date:||June 2000|
|Estimated Study Completion Date:||November 2015|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006256
|United States, Ohio|
|Canton, Ohio, United States, 44708|
|Chardon, Ohio, United States, 44024|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5055|
|Mayfield Heights, Ohio, United States, 44124|
|Mentor, Ohio, United States, 44060|
|Middleburgh Heights, Ohio, United States, 44130|
|Orange Village, Ohio, United States, 44122|
|South Euclid, Ohio, United States, 44121|
|Westlake, Ohio, United States, 44145|
|Study Chair:||Paula Silverman, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|