Clinical trial NCT00005588: Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-05-19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's NHS Trust
state: England
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
state: England
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
state: England
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: England
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital NHS Trust
state: England
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
state: England
city: London
country: United Kingdom
facility: Guy's and St. Thomas' Hospitals Trust
state: England
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: England
city: Manchester
country: United Kingdom
facility: Christie Hospital N.H.S. Trust
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust
state: England
city: Middlesbrough, Cleveland
country: United Kingdom
facility: South Tees Hospitals NHS Trust
state: England
city: Midhurst
country: United Kingdom
facility: King Edward VII Hospital
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
state: England
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital NHS Trust
state: England
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: England
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
state: England
city: Romford
country: United Kingdom
facility: Oldchurch Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
state: England
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
state: England
city: Stoke-On-Trent
country: United Kingdom
facility: North Staffs Royal Infirmary
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: England
city: Torquay Devon
country: United Kingdom
facility: Torbay Hospital
state: England
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend NHS Trust Hospital
state: England
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: England
city: Belfast
country: United Kingdom
facility: Belfast City Hospital Trust Incorporating Belvoir Park Hospital
state: Northern Ireland
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Scotland
city: Cardiff
country: United Kingdom
facility: Velindre Hospital
state: Wales
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary
city: Portsmouth Hants
country: United Kingdom
facility: Saint Mary's Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: John R. Yarnold, MD, FRCR
role: STUDY_CHAIR
References:
citation: 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.
citation: Hopwood 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.
citation: Venables 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.