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3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about 3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection Clinical research trials and 3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection. 3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection clinical trial. Test subjects typically receive the most expert healthcare available for their 3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "3" Clinical Trials Conditions > 3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection  3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection
3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection
For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation therapy in treating women who have undergone lumpectomy and axillary node dissection for stage I or stage II breast cancer.
Details: OBJECTIVES: - Determine the technical feasibility and reproducibility of three-dimensional conformal radiotherapy in women with stage I or II breast cancer previously treated with lumpectomy and axillary node dissection. - Determine the cosmetic results in patients treated with this regimen. - Determine the complication rates in patients treated with this regimen. - Determine the local control rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning within 8 weeks after surgery. Patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 19-46 patients will be accrued for this study within 6.3 to 15.3 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed invasive breast cancer - Stage I or II (T1, N0; T1, N1; T2, N0; or T2, N1) - Unifocal disease (single focus that can be encompassed by one lumpectomy) - The following histologies are eligilble: - Invasive ductal - Medullary - Papillary - Colloid (mucinous) - Tubular - No invasive or extensive in situ lobular carcinoma or pure ductal carcinoma in situ (DCIS) - No nonepithelial breast malignancies such as sarcoma or lymphoma - Previously treated with lumpectomy of a lesion no greater than 3 cm and axillary dissection of at least 6 lymph nodes or a sentinel node biopsy - Six surgical clips in place delineating the margins of the tylectomy cavity - Negative, inked histologic margins of lumpectomy (greater than 2 mm) OR re-excision specimen available for confirmation - Negative mammography post-lumpectomy or post-excision if malignancy-associated microcalcifications were initially present - No prior lumpectomy so extensive that the cosmetic result is low or poor prior to radiotherapy - No more than 3 positive axillary nodes - No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless negative by biopsy - No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless nodes are histologically negative - No extensive intraductal carcinoma, indicated by one of the following according to the Harvard definition: - More than 25 % of invasive tumor is DCIS and DCIS is in adjacent breast tissue - Intraductal carcinoma with microinvasion - No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer - No evidence of suspicious microcalcifications - No Paget's disease of the nipple - No skin involvement by disease, regardless of tumor size - No distant metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - Not specified Life expectancy - At least 2 years Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Technically suitable for breast radiotherapy - No collagenous diseases (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis) - No other medical condition that would limit life expectancy - No psychiatric or addictive disorders that would preclude giving informed consent - No other malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 2 weeks since prior chemotherapy - No concurrent chemotherapy during and for at least 2 weeks after completion of study therapy Endocrine therapy - Concurrent anastrozole or tamoxifen allowed Radiotherapy - No prior radiotherapy for the current malignancy Surgery - See Disease Characteristics Other - No prior nonhormonal therapy for the current malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrankVicini, Study Chair, William Beaumont Hospital - Royal Oak
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Additional Information:
Study ID Numbers: CDR0000316246; RTOG-0319
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068263
Other Stage 2 Breast Cancer Studies:
1. Chemotherapy Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer
2. Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer
3. Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy
4. Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
5. MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
Related Studies:
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3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection
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