Breast Cancer, Radiation Toxicity
Conditions
Keywords
breast cancer, radiotherapy, hypofractionated therapy, nodal irradiation
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.
Interventions
RADIATIONConventional radiotherapy
50 Gy / 25 fractions / 5-6 weeks / Sequential boost of 10 Gy in 5 fractions, in case of conservative surgery.
RADIATIONHypofractionated radiotherapy
40 Gy / 15 fractions / 3 weeks / Concomitant boost with total dose of 48 Gy in 15 fractions, in case of conservative surgery.
Sponsors
Hospital da Baleia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Radiation toxicity will be analysed by a blind second investigator.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Contacts
Primary ContactGabriel Oliveira B Gil, MD
Backup ContactDarly GS Delfino, MSc
Outcome results
None listed