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Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer Clinical research trials and Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer. Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer  Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer
Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer
For Condition: stage 1 breast cancer
Status: Recruiting
Sponsor(s): Cancer Research Campaign Clinical Trials Centre ,
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumors cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy is more effective for early-stage breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of two different regimens of adjuvant chemotherapy plus radiation therapy in treating women who have early-stage breast cancer.
Details: OBJECTIVES: - Compare the effects of synchronous vs sequential adjuvant chemotherapy and radiotherapy on local recurrence, disease-free and overall survival, and treatment delay in women with early-stage breast cancer. - Compare the safety of these regimens, in terms of dose intensity and toxicity, in this patient population. - Evaluate the quality of life and cosmetic outcome in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to axillary clearance (yes vs no), radiotherapy boost intent (boost vs no boost), and chemotherapy intent (cyclophosphamide, methotrexate, and fluorouracil [5-FU] vs anthracycline-containing regimen). Patients are randomized to one of two treatment arms. Patients receive any chemotherapy regimen that includes cyclophosphamide, methotrexate, and fluorouracil. Some regimens may also include epirubicin, doxorubicin, mitoxantrone, and/or mitomycin. - Arm I: Patients receiving synchronous therapy receive any of the above chemotherapy regimens followed by daily radiotherapy after course 2 or 5. Radiotherapy is administered for 3 or 5 weeks. - Arm II: Patients receiving sequential therapy receive any of the above chemotherapy regimens followed by daily radiotherapy after courses 6 or 8. Radiotherapy is administered for 3 or 5 weeks. Treatment in both arms repeats every 3 weeks for 4-8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before chemotherapy, 2-3 weeks after the completion of all treatment, and then at 1, 2, and 5 years. Patients are followed at 1 year and then annually for 10 years. PROJECTED ACCRUAL: A total of 2,250 patients (1,125 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed invasive breast cancer - Early-stage disease - No metastatic disease - Complete surgical excision of tumor - Planned use of adjuvant chemotherapy and radiotherapy - If participating in the cosmetic outcome evaluation portion of the study, must have unilateral disease - Hormone receptor status - Not specified PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Bone marrow function adequate Hepatic: - Hepatic function adequate Renal: - Renal function adequate Cardiovascular: - Cardiac function adequate Other: - No other prior malignancy except basal cell or squamous cell skin cancer or carcinoma in situ - No other medical or social condition that would preclude study compliance - Fit to receive both adjuvant chemotherapy and radiotherapy - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No prior chemotherapy Endocrine therapy: - Prior or concurrent hormonal therapy allowed - No concurrent tamoxifen if treated with methotrexate, mitomycin, and mitoxantrone as a study combination chemotherapy regimen Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics Other: - Concurrent participation in another clinical trial allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IndyFernando, Study Chair, Queen Elizabeth Hospital at University of Birmingham
Queen Elizabeth Hospital at University of Birmingham *Recruiting*
Birmingham, England, B15 2TH
United Kingdom
Recruiting Indy Fernando 44-121-472-1311
Additional Information:
Study ID Numbers: CDR0000067062; CRC-TU-BR3015,EU-99005
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003893
Other Stage 1 Breast Cancer Studies:
1. Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
2. Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer
3. Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
4. Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
5. Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other England Clinical Trials
Other Birmingham Clinical Trials
Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer
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