Breast CancerPhase 3NCT00005588
Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
A Phase 3 study testing radiation therapy in people with Breast Cancer, run by Medical Research Council at 32 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 32 sitesUnited Kingdom
- Study dates
- Jan 1999to Dec 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United Kingdom32 sites
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Belfast, Northern Ireland, BT8 8JR
Royal Sussex County Hospital
Brighton, England, BN2 5BE
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
Velindre Hospital
Cardiff, Wales, CF4 7XL
Cumberland Infirmary
Carlisle, CA2 7HY
Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Royal Surrey County Hospital
Guildford, England, GU2 5XX
Ipswich Hospital NHS Trust
Ipswich, England, IP4 5PD
University Hospitals of Leicester
Leicester, England, LE1 5WW
Guy's and St. Thomas' Hospitals Trust
London, England, SE1 9RT
Maidstone Hospital
Maidstone, England, ME16 9QQ
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
South Tees Hospitals NHS Trust
Middlesbrough, Cleveland, England, TS4 3BW
King Edward VII Hospital
Midhurst, England, GU29 OBL
Mount Vernon Hospital
Northwood, England, HA6 2RN
Norfolk & Norwich Hospital
Norwich, England, NR1 3SR
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Derriford Hospital
Plymouth, England, PL6 8DH
Saint Mary's Hospital
Portsmouth Hants, PO3 6AD
Royal Preston Hospital
Preston, PR2 9HT
Royal Berkshire Hospital
Reading, England, RG1 5AN
Oldchurch Hospital
Romford, England, RM7 OBE
Weston Park Hospital
Sheffield, England, S1O 2SJ
Royal Shrewsbury Hospital
Shrewsbury, England
North Staffs Royal Infirmary
Stoke-on-Trent, England, ST4 7LN
Royal Marsden Hospital
Sutton, England, SM2 5PT
Torbay Hospital
Torquay Devon, England, TQ2 7AA
Southend NHS Trust Hospital
Westcliff-on-Sea, England
New Cross Hospital
Wolverhampton, England, WV10 0QP
About this study
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
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- radiation therapy
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2003 (estimated)
- Study startJan 1999
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- John R. Yarnold, MD, FRCR, Study chair, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005588
- Sponsor's protocol ID
- CDR0000067662
- Other IDs
- STMG-STARTA, EU-99014
- Status last verified
- Jun 2000
- First submitted
- 2 May 2000
- Last updated
- 19 Dec 2013
- Results posted
- No
Publications
Hopwood P, Haviland JS, Sumo G, Mills J, Bliss JM, Yarnold JR; START Trial Management Group. Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy (START) trials. Lancet Oncol. 2010 Mar;11(3):231-40. doi: 10.1016/S1470-2045(09)70382-1. Epub 2010 Feb 6.
PubMed 20138809Hopwood P, Haviland J, Mills J, Sumo G, M Bliss J; START Trial Management Group. The impact of age and clinical factors on quality of life in early breast cancer: an analysis of 2208 women recruited to the UK START Trial (Standardisation of Breast Radiotherapy Trial). Breast. 2007 Jun;16(3):241-51. doi: 10.1016/j.breast.2006.11.003. Epub 2007 Jan 19.
PubMed 17236771Venables K, Miles EA, Aird EG, Hoskin PJ; START Trial Management Group. The use of in vivo thermoluminescent dosimeters in the quality assurance programme for the START breast fractionation trial. Radiother Oncol. 2004 Jun;71(3):303-10. doi: 10.1016/j.radonc.2004.02.008.
PubMed 15172146
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00005588
- Acronym / sponsor ID
- CDR0000067662
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Jan 1999
- Study completion
- Dec 2004 (actual)
- First posted
- 19 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Results publication: PubMed 20138809Hopwood P, Haviland JS, Sumo G, Mills J, Bliss JM, Yarnold JR; START Trial Management Group. Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy (START) trials. Lancet Oncol. 2010 Mar;11(3):231-40. doi: 10.1016/S1470-2045(09)70382-1. Epub 2010 Feb 6.
- Results publication: PubMed 17236771Hopwood P, Haviland J, Mills J, Sumo G, M Bliss J; START Trial Management Group. The impact of age and clinical factors on quality of life in early breast cancer: an analysis of 2208 women recruited to the UK START Trial (Standardisation of Breast Radiotherapy Trial). Breast. 2007 Jun;16(3):241-51. doi: 10.1016/j.breast.2006.11.003. Epub 2007 Jan 19.
- Results publication: PubMed 15172146Venables K, Miles EA, Aird EG, Hoskin PJ; START Trial Management Group. The use of in vivo thermoluminescent dosimeters in the quality assurance programme for the START breast fractionation trial. Radiother Oncol. 2004 Jun;71(3):303-10. doi: 10.1016/j.radonc.2004.02.008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R. Yarnold, MD, FRCR study chair
Royal Marsden NHS Foundation Trust
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation therapy in people with Breast Cancer, run by Medical Research Council at 32 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005588, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.