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Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive 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 Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer Clinical research trials and Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive 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 Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer. Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive 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 Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive 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 > "R" Clinical Trials Conditions > Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer  Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer
Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer
For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada , National Cancer Institute (NCI),National Surgical Adjuvant Breast and Bowel Project (NSABP),Radiation Therapy Oncology Group,Southwest Oncology Group,Trans-Tasman Radiation Oncological Group,North Central Cancer Treatment Group
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of radiation therapy to the breast alone following surgery with that of radiation therapy to the breast plus surrounding tissue in treating women who have early-stage invasive breast cancer.
Details: OBJECTIVES: - Compare the overall survival, disease-free survival, isolated local regional disease-free survival, and distant disease-free survival in women with previously resected, early stage, invasive breast cancer treated with breast radiotherapy with or without regional radiotherapy. - Compare the toxic effects of these regimens in these patients. - Compare the quality of life of patients (in certain participating centers) treated with these regimens. - Compare the cosmetic outcomes in patients (in certain participating centers) treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs more than 3), type of chemotherapy (anthracycline containing vs other vs none), hormonal therapy (yes vs no), number of axillary lymph nodes excised (less than 10 vs 10 or more), and participating center. Patients are randomized to one of two treatment arms. - Arm I: Patients undergo standard breast radiotherapy alone 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. - Arm II: Patients undergo breast and regional radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Radiotherapy in both arms begins as soon as possible after randomization. Radiotherapy must begin within 8 weeks after completion of adjuvant IV chemotherapy, unless radiotherapy is administered concurrently with chemotherapy (i.e., cyclophosphamide, methotrexate, and fluorouracil [CMF]), or within 16 weeks after the last breast surgery for patients treated with hormonal therapy alone. Quality of life is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 and 9 months after completion of radiotherapy, and then annually until first distant disease recurrence. Cosmetic outcome is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, and then at 3 and 5 years after completion of radiotherapy or until first distant disease recurrence. Patients are followed at 3, 6, and 9 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 1,822 patients will be accrued for this study within approximately 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven invasive carcinoma of the breast - No evidence of T4, N2-3, or M1 disease prior to surgery - Node positive or high-risk node negative - Prior breast-conserving therapy (BCT) (e.g., lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy required and must be a candidate for breast radiotherapy after BCT - Normally patients should have microscopically clear resection margins and those with positive margins should undergo reexcision - Patients with microscopically focally positive margins (defined as no greater than 3 times high power fields) are candidates for breast radiotherapy plus a boost to the lumpectomy site - Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria - If node positive, then a level I and II axillary dissection must be performed - No evidence of residual disease in axilla after dissection - Must be treated with currently accepted adjuvant systemic chemotherapy and/or hormonal therapy - High risk of regional and systemic recurrence due to one of the following: - Pathologically positive axillary lymph nodes - Pathologically negative axillary lymph nodes with one of the following: - Primary tumor greater than 5 cm - Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following: - Estrogen receptor negative - Skarf-Bloom-Richardson grade 3 - Lymphovascular invasion - Hormone receptor status: - Estrogen and progesterone receptor status known PATIENT CHARACTERISTICS: Age: - 16 and over Sex: - Female Menopausal status: - Premenopausal or postmenopausal Performance status: - ECOG 0-2 Life expectancy: - At least 5 years Hematopoietic: - Not specified Hepatic: - SGOT and/or SGPT no greater than 3 times upper limit of normal (ULN)* - Alkaline phosphatase no greater than 3 times ULN* NOTE: * Patients with laboratory values greater than 3 times ULN may still be eligible if no metastatic disease by imaging examinations Renal: - No serious nonmalignant renal disease Cardiovascular: - No serious nonmalignant cardiovascular disease Pulmonary: - No serious nonmalignant pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No other serious nonmalignant disease (e.g., systemic lupus erythematosus or scleroderma) that would preclude definitive surgery or radiotherapy - No other malignancy except: - Nonmelanomatous skin cancer - Carcinoma in situ of the cervix or endometrium - Contralateral noninvasive breast cancer (unless prior radiotherapy to the contralateral breast) - Invasive carcinoma of the cervix, endometrium, colon, thyroid, or melanoma that was curatively treated at least 5 years prior to study participation - No psychiatric or addictive disorder that would preclude informed consent or study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - Concurrent standard adjuvant chemotherapy allowed Endocrine therapy: - See Disease Characteristics - Concurrent standard adjuvant hormonal therapy allowed Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyWhelan, Study Chair, Margaret and Charles Juravinski Cancer Centre
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Lorna Weir 604-877-6000 ext. 2665
Hopital du Saint-Sacrement, Quebec *Recruiting*
Quebec City, Quebec, G1S 4L8
Canada
Recruiting Jean Robert 418-682-8032
Northeastern Ontario Regional Cancer Centre - Sudbury *Recruiting*
Sudbury, Ontario, P3E 5J1
Canada
Recruiting Julie Bowen 705-522-6237 - ext. 2512
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Ida Ackerman 416-480-4951
Centre Hospitalier des Vallées de l'Outaouais *Recruiting*
Gatineau, Quebec, J8P 7H2
Canada
Recruiting Robert Archambault 819-561-8100
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
Kingston Regional Cancer Centre *Recruiting*
Kingston, Ontario, K7L 5P9
Canada
Recruiting Wendy Shelley 613-544-2631, ext. 4173
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Peter Craighead 403-944-1651
Nova Scotia Cancer Centre *Recruiting*
Halifax, Nova Scotia, B3H 1V7
Canada
Recruiting Dorianne Rheaume 902-473-6096
Northwestern Ontario Regional Cancer Care *Recruiting*
Thunder Bay, Ontario, P7B 6V4
Canada
Recruiting Conrad Falkson 807-684-7210
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Laura Vallow 904-953-1040
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Paul DeMare 808-586-2979
Centre Hospitalier Universitaire de Quebec *Recruiting*
Quebec City, Quebec, G1R 2J6
Canada
Recruiting Andre Fortin 418-691-5264
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
Harrington Cancer Center *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting James Clarkson 806-359-4673
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Susan Chafe 780-432-8518
Newfoundland Cancer Treatment and Research Foundation *Recruiting*
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Recruiting Brent Tompkins 709-777-6480
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
McGill University *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting Christine Lambert 514-934-8040
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Haji Chalchal 306-766-2691
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Timothy Whelan 905-387-9711 ext. 64501
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Katherine Vallis 416-946-2121
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting Mark Olsen 918-499-2000
Centre Hospitalier de l'Universite de Montreal *Recruiting*
Montreal, Quebec, H2L-4M1
Canada
Recruiting Pierre Rousseau 514-890-8254
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
Fraser Valley Cancer Centre at British Columbia Cancer Agency *Recruiting*
Surrey, British Columbia, V3V 1Z2
Canada
Recruiting Winkle Kwan 604-930-4032
CHUS-Hopital Fleurimont *Recruiting*
Fleurimont, Quebec, J1H 5N4
Canada
Recruiting Abdenour Nabid 819-346-1110 ext. 14602
Hotel Dieu Health Sciences Hospital - Niagara *Recruiting*
St. Catharines, Ontario, L2R 5K3
Canada
Recruiting Brian Findlay 905-682-6451
Doctor Leon Richard Oncology Centre *Recruiting*
Moncton, New Brunswick, E1C 8X3
Canada
Recruiting Fernando Rojas 506-862-4230
Saskatoon Cancer Centre *Recruiting*
Saskatoon, Saskatchewan, S7N 4H4
Canada
Recruiting David Skarsgard 306-655-2740
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Francisco Perera 519-685-8650
CancerCare Manitoba *Recruiting*
Winnipeg, Manitoba, R3E 0V9
Canada
Recruiting James Butler 204-787-2153
Saint John Regional Hospital *Recruiting*
Saint John, New Brunswick, E2L 4L2
Canada
Recruiting Nancy Grant 506-648-6884
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Joanne Meng 613-737-7700, ext. 6750
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212
United States
Recruiting David Parda 412-359-8084
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
Fletcher Allen Health Care - University Health Center Campus *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting Steven Grunberg 802-847-8400
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Steven Alberts 507-284-2511
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
Additional Information:
Study ID Numbers: CDR0000067938; RTOG-CAN-NCIC-MA20,CAN-NCIC-MA20,SWOG-CAN-NCIC-MA20,NCCTG-CAN-NCIC-MA20,TROG-CAN-NCIC-MA20,NSABP-CAN-NCIC-MA20
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005957
Other Stage 1 Breast Cancer Studies:
1. Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
2. Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
3. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
4. ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer
5. Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other Saskatchewan Clinical Trials
Other Saskatoon Clinical Trials
Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer
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