Hypofractionated Versus Conventional Fractionation Radiotherapy

• Sponsor: Hospital da Baleia (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04015531
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 17.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Radiation Toxicity	Radiation: Conventional radiotherapy; Radiation: Hypofractionated radiotherapy	N/A

Detailed Description

Investigators hypothesize that hypofractionated radiotherapy is equal effective and safe as conventional radiotherapy in breast cancer patients undergoing regional nodal irradiation.

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Radiation toxicity will be analysed by a blind second investigator.
• Primary Purpose: Treatment
• Official Title: Hypofractionated Versus Conventional Fractionation Radiation After Conservative Surgery or Mastectomy With Irradiation of Lymph Node Drainage: a Phase II Randomized Clinical Trial for the Evaluation of Acute Toxicity
• Anticipated Study Start Date: Jul 1, 2019
• Anticipated Primary Completion Date: May 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Radiation: Conventional radiotherapy; 50 Gy / 25 fractions / 5-6 weeks / Sequential boost of 10 Gy in 5 fractions, in case of conservative surgery.; Other Names: Standard fractionation
Experimental: 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.	Radiation: 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 Names: Hypofractionated therapy

Outcome Measures

Primary Outcome Measures

1. CTCAE Toxicity Assessement - Acute Toxicity [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.]

   Change in acute toxicity will be assessed according to criteria of CTCAE version 4.03.

Secondary Outcome Measures

1. 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.]

   Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3).

2. 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.]

   Patients' quality of life will be assessed using self-administered questionnaire EORTC breast cancer module (BR23).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital da Baleia

Investigators

• Principal Investigator: Gabriel Oliveira B Gil, MD, Baleia Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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. Erratum in: Lancet. 2014 Nov 22;384(9957):1848.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Hospital da Baleia
• ClinicalTrials.gov Identifier: NCT04015531
• Other Study ID Numbers: RT 1901
• First Posted: Jul 11, 2019
• Last Update Posted: Jul 11, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospital da Baleia: breast cancer; radiotherapy; hypofractionated therapy; nodal irradiation
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jul 11, 2019