Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2000 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Medical Research Council
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005588
First received: May 2, 2000
Last updated: February 12, 2010
Last verified: June 2000
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Purpose
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 different regimens of radiation therapy following surgery in treating women who have early stage breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Standardization of Breast Radiotherapy: Trial A - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | January 1999 |
OBJECTIVES:
- 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.
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 3 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 fortnight (i.e., Monday/Wednesday/Friday/Tuesday/Thursday/Monday, etc.) for 13 fractions over 5 weeks for a total dose of 41.6 Gy.
- Arm III: Patients receive radiotherapy as in arm II for a total dose of 39 Gy. A breast boost is recommended in all 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 2,010 patients (670 per arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed invasive unilateral breast cancer that is considered operable
- 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
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
PRIOR CONCURRENT THERAPY:
- Prior neoadjuvant, or primary medical, therapy 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005588
Locations
| United Kingdom | |
| Royal Sussex County Hospital | |
| Brighton, England, United Kingdom, BN2 5BE | |
| Addenbrooke's NHS Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Cheltenham General Hospital | |
| Cheltenham, England, United Kingdom, GL53 7AN | |
| Royal Devon and Exeter Hospital | |
| Exeter, England, United Kingdom, EX2 5DW | |
| Royal Surrey County Hospital | |
| Guildford, England, United Kingdom, GU2 5XX | |
| Ipswich Hospital NHS Trust | |
| Ipswich, England, United Kingdom, IP4 5PD | |
| University Hospitals of Leicester | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Guy's and St. Thomas' Hospitals Trust | |
| London, England, United Kingdom, SE1 9RT | |
| Maidstone Hospital | |
| Maidstone, England, United Kingdom, ME16 9QQ | |
| Christie Hospital N.H.S. Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, L63 4JY | |
| South Tees Hospitals NHS Trust | |
| Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW | |
| King Edward VII Hospital | |
| Midhurst, England, United Kingdom, GU29 OBL | |
| Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| Norfolk & Norwich Hospital | |
| Norwich, England, United Kingdom, NR1 3SR | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Derriford Hospital | |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Royal Berkshire Hospital | |
| Reading, England, United Kingdom, RG1 5AN | |
| Oldchurch Hospital | |
| Romford, England, United Kingdom, RM7 OBE | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Royal Shrewsbury Hospital | |
| Shrewsbury, England, United Kingdom | |
| North Staffs Royal Infirmary | |
| Stoke-On-Trent, England, United Kingdom, ST4 7LN | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Torbay Hospital | |
| Torquay Devon, England, United Kingdom, TQ2 7AA | |
| Southend NHS Trust Hospital | |
| Westcliff-On-Sea, England, United Kingdom | |
| New Cross Hospital | |
| Wolverhampton, England, United Kingdom, WV10 0QP | |
| Belfast City Hospital Trust Incorporating Belvoir Park Hospital | |
| Belfast, Northern Ireland, United Kingdom, BT8 8JR | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Velindre Hospital | |
| Cardiff, Wales, United Kingdom, CF4 7XL | |
| Cumberland Infirmary | |
| Carlisle, United Kingdom, CA2 7HY | |
| Saint Mary's Hospital | |
| Portsmouth Hants, United Kingdom, PO3 6AD | |
| Royal Preston Hospital | |
| Preston, United Kingdom, PR2 9HT | |
Sponsors and Collaborators
Medical Research Council
Investigators
| Study Chair: | John R. Yarnold, MD, FRCR | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00005588 History of Changes |
| Other Study ID Numbers: | CDR0000067662, STMG-STARTA, EU-99014 |
| Study First Received: | May 2, 2000 |
| Last Updated: | February 12, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013