Hypofractionated Versus Conventional Fractionation Radiotherapy

Study Overview
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Brief Summary
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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
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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: 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; 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.

Official Title
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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

Conditions
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Breast Cancer, Radiation Toxicity

Intervention / Treatment
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* Radiation: Conventional radiotherapy
* Radiation: Hypofractionated radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional radiotherapy<br>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<br>* 50 Gy / 25 fractions / 5-6 weeks / Sequential boost of 10 Gy in 5 fractions, in case of conservative surgery.<br>* Other names: Standard fractionation;|
| Experimental: Hypofractionated radiotherapy<br>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<br>* 40 Gy / 15 fractions / 3 weeks / Concomitant boost with total dose of 48 Gy in 15 fractions, in case of conservative surgery.<br>* Other names: Hypofractionated therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - EORTC QLQ-C30 (version 3) | Patients' quality of life will be assessed using self-administered questionnaire 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) | Patients' quality of life will be assessed using self-administered questionnaire 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, radiotherapy, hypofractionated therapy, nodal irradiation