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Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Radiation Therapy After Surgery 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. Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer Clinical research trials and Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer. Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer  Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
For Condition: stage 2 breast cancer,stage 3A breast cancer,stage 1 breast cancer
Status: No longer recruiting
Sponsor(s): START Trial Management Group ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective following surgery for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of radiation therapy following surgery in treating women who have early stage breast cancer.
Details: OBJECTIVES: I. Determine the benefits of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of normal tissue responses, local-regional tumor control, quality of life, and economic consequences in women prescribed postoperative radiotherapy for early stage breast cancer. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, type of surgery (mastectomy vs local excision), and breast boost (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive radiotherapy 5 times a week for 5 weeks for a total dose of 50 Gy. Arm II: Patients receive radiotherapy 5 times a week for 3 weeks for a total dose of 40 Gy. A breast boost is recommended in both arms for patients with microscopic evidence of invasive or in situ cancer at, or within 1 mm of, a resection margin. These patients receive radiotherapy for 5 fractions in 1 week for a total boost dose of 10 Gy. Quality of life is assessed at baseline and then at 6, 12, 24, and 60 months. Patients are followed annually for up to 20 years. PROJECTED ACCRUAL: A total of 1840 patients (920 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed invasive unilateral breast cancer - T1-3, N0-1, M0 at presentation Complete macroscopic excision of tumor by breast conserving surgery or mastectomy No immediate breast reconstruction No requirement for axillary radiotherapy after greater than a Level 1 axillary dissection or after greater than 10 lymph nodes have been removed Not enrolled on SECRAB or OSCAR trials Hormone receptor status: Not specified --Prior/Concurrent Therapy-- Prior neoadjuvant, or primary medical, therapy is allowed provided subsequent surgery confirms complete macroscopic excision of residual primary tumor Biologic therapy: Not specified Chemotherapy: - At least 2 weeks since prior cytotoxic agents - No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics --Patient Characteristics-- Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnYarnold, Study Chair, START Trial Management Group
Derriford Hospital
Plymouth, England, PL6 8DH
United Kingdom
Ipswich Hospital NHS Trust
Ipswich, England, IP4 5PD
United Kingdom
South Tees Hospitals NHS Trust
Middlesbrough, Cleveland, England, TS4 3BW
United Kingdom
Saint Mary's Hospital
Portsmouth Hants, , PO3 6AD
United Kingdom
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Mount Vernon Hospital
Northwood, England, HA6 2RN
United Kingdom
Oldchurch Hospital
Romford, England, RM7 OBE
United Kingdom
Royal Preston Hospital
Preston, , PR2 9HT
United Kingdom
Torbay Hospital
Torquay Devon, England, TQ2 7AA
United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
United Kingdom
Guy's and St. Thomas' Hospitals Trust
London, England, SE1 9RT
United Kingdom
Royal Sussex County Hospital
Brighton, England, BN2 5BE
United Kingdom
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
United Kingdom
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Velindre Hospital
Cardiff, Wales, CF4 7XL
United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Cheltenham General Hospital
Cheltenham, England, GL53 7AN
United Kingdom
New Cross Hospital
Wolverhampton, England, WV10 0QP
United Kingdom
King Edward VII Hospital
Midhurst, England, GU29 OBL
United Kingdom
Maidstone Hospital
Maidstone, England, ME16 9QQ
United Kingdom
Cumberland Infirmary
Carlisle, , CA2 7HY
United Kingdom
North Staffs Royal Infirmary
Stoke on Trent, England, ST4 7LN
United Kingdom
Royal Surrey County Hospital
Guildford, England, GU2 5XX
United Kingdom
Norfolk & Norwich Hospital
Norwich, England, NR1 3SR
United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
University Hospitals of Leicester
Leicester, England, LE1 5WW
United Kingdom
Royal Berkshire Hospital
Reading, England, RG1 5AN
United Kingdom
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Belfast, Northern Ireland, BT8 8JR
United Kingdom
Southend NHS Trust Hospital
Westcliff-On-Sea, England,
United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England,
United Kingdom
Additional Information:
Study ID Numbers: CDR0000067661; EU-99015,STMG-STARTB
Study Start Date: January 1999
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005587
Other Stage 3a Breast Cancer Studies:
1. Combination Chemotherapy After Surgery With or Without Chinese Herbal Therapy to Treat Symptoms in Women With Breast Cancer
2. Soy Isoflavone Compared With No Treatment Before Surgery in Treating Patients With Breast Cancer
3. Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy
4. Nutrition Intervention in Treating Women With Breast Cancer
5. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other England Clinical Trials
Other Stoke on Trent Clinical Trials
Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
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