Hypofractionated Versus Conventional Fractionation Radiotherapy

Hospital da Baleia

Status: Unknown

Conditions: Breast Cancer; Radiation Toxicity

Treatments: Radiation: Conventional radiotherapy; Radiation: Hypofractionated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04015531

RT 1901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Conventional radiotherapy

Active Comparator group

Description:

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.

Treatment:

Radiation: Conventional radiotherapy

Hypofractionated radiotherapy

Experimental group

Description:

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.

Treatment:

Radiation: Hypofractionated radiotherapy