Clinical trial NCT04015531: Hypofractionated Versus Conventional Fractionation Radiotherapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Radiation Toxicity
Keywords: breast cancer
radiotherapy
hypofractionated therapy
nodal irradiation
Lead sponsor: Hospital da Baleia
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CTCAE Toxicity Assessement - Acute Toxicity
timeFrame: 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 outcomes:
measure: Quality of Life - EORTC QLQ-C30 (version 3)
timeFrame: 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.
measure: Quality of Life - EORTC breast cancer module (BR23)
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Baleia Hospital
name: Gabriel Oliveira B Gil, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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