Hypofractionated Versus Conventional Fractionation Radiotherapy
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
This study was designed to evaluate the acute toxicity and quality of life of hypofractionated radiation versus conventional when regional node irradiation is indicated after breast-conserving surgery or mastectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Jul 2019
Shorter than P25 for not_applicable breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2016
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 11, 2019
July 1, 2019
10 months
August 8, 2016
July 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CTCAE Toxicity Assessement - Acute Toxicity
Change in acute toxicity will be assessed according to criteria of CTCAE version 4.03.
Before treatment, every week of treatment (week 1 to 3 or 1 to 5-6, according to the treatment arm), at the end of treatment (week 3 or week 5-6, according to the treatment arm), 4, 8 and 24 weeks after the last fraction received.
Secondary Outcomes (2)
Quality of Life - EORTC QLQ-C30 (version 3)
Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received.
Quality of Life - EORTC breast cancer module (BR23)
Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received.
Study Arms (2)
Conventional radiotherapy
ACTIVE COMPARATOR50 Gy in 25 fractions to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla), followed by tumor bed boost of 10 Gy in 5 fractions in case of breast conserving surgery. Total time: 5-6 weeks.
Hypofractionated radiotherapy
EXPERIMENTAL40 Gy in 15 fractions (2.67 Gy each) to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla). Patients undergoing breast conserving surgery will receive concomitant boost with total dose of 48 Gy in 15 fractions (3.20 Gy each) to tumor bed. Total time: 3 weeks.
Interventions
50 Gy / 25 fractions / 5-6 weeks / Sequential boost of 10 Gy in 5 fractions, in case of conservative surgery.
40 Gy / 15 fractions / 3 weeks / Concomitant boost with total dose of 48 Gy in 15 fractions, in case of conservative surgery.
Eligibility Criteria
You may qualify if:
- Female;
- Older than 18;
- Breast cancer stage T1 - T3;
- At least 1 lymph node positive;
- Treated with mastectomy or conservative surgery;
- Negative surgical margins;
- No distant metastasis;
- No supraclavicular or internal mammary nodes metastases;
- Adjuvant systemic therapy with chemotherapy, endocrine therapy or anti-HER2 (Human - - Epidermal Growth Factor Receptor 2) treatment is accepted;
- Signed informed consent.
You may not qualify if:
- Positive surgical margins;
- Concomitant chemotherapy;
- Supraclavicular or internal mammary nodes metastases;
- Distant metastasis;
- Previous thoracic radiotherapy;
- Bilateral breast cancer;
- Patients with collagen diseases;
- Unable or unwilling to sign inform consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
Wang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30.
PMID: 30711522BACKGROUNDEBCTCG (Early Breast Cancer Trialists' Collaborative Group); McGale P, Taylor C, Correa C, Cutter D, Duane F, Ewertz M, Gray R, Mannu G, Peto R, Whelan T, Wang Y, Wang Z, Darby S. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014 Jun 21;383(9935):2127-35. doi: 10.1016/S0140-6736(14)60488-8. Epub 2014 Mar 19.
PMID: 24656685BACKGROUNDDuxbury PJ, Gandhi A, Kirwan CC, Jain Y, Harvey JR. Current attitudes to breast reconstruction surgery for women at risk of post-mastectomy radiotherapy: A survey of UK breast surgeons. Breast. 2015 Aug;24(4):502-12. doi: 10.1016/j.breast.2015.05.002. Epub 2015 May 26.
PMID: 26021276BACKGROUNDSTART Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19.
PMID: 18356109BACKGROUNDShaitelman SF, Schlembach PJ, Arzu I, Ballo M, Bloom ES, Buchholz D, Chronowski GM, Dvorak T, Grade E, Hoffman KE, Kelly P, Ludwig M, Perkins GH, Reed V, Shah S, Stauder MC, Strom EA, Tereffe W, Woodward WA, Ensor J, Baumann D, Thompson AM, Amaya D, Davis T, Guerra W, Hamblin L, Hortobagyi G, Hunt KK, Buchholz TA, Smith BD. Acute and Short-term Toxic Effects of Conventionally Fractionated vs Hypofractionated Whole-Breast Irradiation: A Randomized Clinical Trial. JAMA Oncol. 2015 Oct;1(7):931-41. doi: 10.1001/jamaoncol.2015.2666.
PMID: 26247543BACKGROUNDBekelman JE, Sylwestrzak G, Barron J, Liu J, Epstein AJ, Freedman G, Malin J, Emanuel EJ. Uptake and costs of hypofractionated vs conventional whole breast irradiation after breast conserving surgery in the United States, 2008-2013. JAMA. 2014 Dec 17;312(23):2542-50. doi: 10.1001/jama.2014.16616.
PMID: 25494006BACKGROUNDJagsi R, Falchook AD, Hendrix LH, Curry H, Chen RC. Adoption of hypofractionated radiation therapy for breast cancer after publication of randomized trials. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1001-9. doi: 10.1016/j.ijrobp.2014.09.032.
PMID: 25539365BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Oliveira B Gil, MD
Baleia Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Radiation toxicity will be analysed by a blind second investigator.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2016
First Posted
July 11, 2019
Study Start
July 1, 2019
Primary Completion
May 1, 2020
Study Completion
December 1, 2020
Last Updated
July 11, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- From 2020 onwards
- Access Criteria
- Principal investigator's e-mail
Use of a controlled access approach, with a transparent system to review requests and provide secure data access; assurance that patient privacy and confidentiality can be maintained;