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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel | Drug | 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. | ||
| adjuvant therapy | Procedure | doxorubicin and cyclophosphamide adjuvant regimen | ||
| radiation therapy | Radiation | Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the feasibility of concurrent paclitaxel and breast radiotherapy | Ability to deliver appropriate doses of radiation therapy within the appropriate time course | Followed every 3 months for 1 year |
| chemotherapy dose achieved during concurrent Taxol and radiation therapy. | Followed every 3 months for 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor. | 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. | 1 year |
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DISEASE CHARACTERISTICS:
Stage II or III invasive breast cancer
Prior breast conserving surgery (lumpectomy or quadrantectomy) with ipsilateral axillary lymph node dissection required
No prior contralateral breast cancer
No metastatic disease
Prior ductal carcinoma in situ or lobular carcinoma in situ of the breast allowed unless treated with radiation or chemotherapy
Doxorubicin and cyclophosphamide adjuvant chemotherapy completed within past 3 weeks
Candidate for definitive radiotherapy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Lyons, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH-CantonMercy | Canton | Ohio | 44708 | United States | ||
| UH-Geauga |
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| Pulmonary function |
Combined treatment impact on pulmonary function. Evidence of pulmonary toxicity demonstrated by a reduction in DLCO (Diffusing Capacity of the Lung for Carbon Monoxide). |
| 1 year |
| Survival | Patients followed for long term survival for at least 5 years. | 5 years |
| Chardon |
| Ohio |
| 44024 |
| United States |
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5055 | United States |
| UH-Monarch | Mayfield Heights | Ohio | 44124 | United States |
| UH-LUICC | Mentor | Ohio | 44060 | United States |
| UH-Southwest | Middleburg Heights | Ohio | 44130 | United States |
| UH-Chagrin Highlands | Orange | Ohio | 44122 | United States |
| UH-Green Road | South Euclid | Ohio | 44121 | United States |
| UH-Westlake | Westlake | Ohio | 44145 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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