Hypofractionated Versus Conventional Fractionation Radiotherapy

Not Applicable

• Conditions: Breast Cancer; Radiation Toxicity
• Interventions: Radiation: Hypofractionated radiotherapy; Radiation: Conventional radiotherapy

• Registration Number: NCT04015531
• Lead Sponsor: Hospital da Baleia

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.

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 Timeline

• Study First Submitted: 2016-08-08
• Status Verified: 2019-07
• Study Start: 2019-07
• Study First Submitted QC: 2019-07-10
• Last Update Submitted: 2019-07-10
• Study First Posted: 2019-07-11
• Last Update Posted: 2019-07-11
• Primary Completion: 2020-05
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypofractionated radiotherapy	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.
Conventional radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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).