Hypofractionated Versus Conventional Fractionation Radiotherapy
NCT ID: NCT04015531
Last Updated: 2019-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2019-07-31
2020-12-31
Brief Summary
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Detailed Description
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Eligible breast cancer patients are randomized 1:1 into the following two groups:
1. Hypofractionated therapy: 40 Gy in 15 fractions of 2.67 Gy in breast or chest wall and nodal drainage with Concurrent boost 48.0 Gy / 3.2 Gy daily in tumor bed, in case of conservative surgery;
2. Standard fractionation: 50 Gy in 25 fractions in breast or chest wall and nodal drainage with sequential tumor bed boost with 10 Gy in 5 fractions in tumor bed in case of conservative surgery.
Patients will be followed for 6 months after radiotherapy to evaluate acute toxicity and quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Conventional radiotherapy
50 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.
Conventional radiotherapy
50 Gy / 25 fractions / 5-6 weeks / Sequential boost of 10 Gy in 5 fractions, in case of conservative surgery.
Hypofractionated radiotherapy
40 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.
Hypofractionated radiotherapy
40 Gy / 15 fractions / 3 weeks / Concomitant boost with total dose of 48 Gy in 15 fractions, in case of conservative surgery.
Interventions
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Conventional radiotherapy
50 Gy / 25 fractions / 5-6 weeks / Sequential boost of 10 Gy in 5 fractions, in case of conservative surgery.
Hypofractionated radiotherapy
40 Gy / 15 fractions / 3 weeks / Concomitant boost with total dose of 48 Gy in 15 fractions, in case of conservative surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Hospital da Baleia
OTHER
Responsible Party
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Principal Investigators
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Gabriel Oliveira B Gil, MD
Role: PRINCIPAL_INVESTIGATOR
Baleia Hospital
Central Contacts
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References
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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.
EBCTCG (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.
Duxbury 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.
START 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.
Shaitelman 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.
Bekelman 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.
Jagsi 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.
Other Identifiers
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RT 1901
Identifier Type: -
Identifier Source: org_study_id
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