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Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer Clinical research trials and Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer. Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer  Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
For Condition: stage 3B breast cancer,stage 2 breast cancer,stage 3A breast cancer,stage 3C breast cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of paclitaxel and radiation therapy in treating women who have stage II or stage III breast cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm3 - Granulocyte count at least 2,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT/AST no greater than 1.5 times ULN Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No concurrent poorly controlled ischemic heart disease or congestive heart failure - LVEF at least 45% by MUGA scan or echocardiogram Pulmonary: - No concurrent severe chronic obstructive or restrictive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No concurrent severe medical or psychiatric illness - No concurrent severe diabetes mellitus - No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix treated with local excision PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent filgrastim (G-CSF) Chemotherapy: - See Disease Characteristics - Prior tamoxifen allowed - No concurrent tamoxifen Endocrine therapy: - Not specified Radiotherapy: - No prior radiation to the breast Surgery: - Recovered form prior surgery Other: - No concurrent adjuvant therapy on another clinical trial
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BethOvermoyer, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5055
United States
Recruiting Beth Overmoyer 216-844-3862
Additional Information:
Study ID Numbers: CDR0000068189; CWRU-2199,NCI-G00-1851,BMS-CWRU-2199
Study Start Date:
Record last reviewed: September 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006256
Other Stage 3a Breast Cancer Studies:
1. Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer
2. Combination Chemotherapy and Filgrastim Followed by Radiation Therapy in Treating Patients With Stage II or Stage IIIA Breast Cancer
3. Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer
4. Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer
5. Lymph Node Radiation Therapy in Patients with Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
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