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Clinical Trials in Italy / NCT03077191
Active, not recruiting Observational

Toxicity and Outcome of Whole Breast Hypofractionated Radiotherapy: a Single Institution Experience

NCT03077191 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2016-11-01
Last updated
2025-04-22

Condition(s) studied

Breast CancerQuality of LifeRadiotherapy; Adverse Effect, Dermatitis or EczemaSurvivorship

Investigational drug(s) / intervention(s)

Quality of life measurement

Quality of life measurement: The quality of life of breast cancer patients treated with conservative surgery and adjuvant whole breast hypofractionated radiotherapy, without boost, will be evaluated.

Study summary

This is a homogeneous, single institution, observational, non-interventional, prospective study of 500 patients who will be treated according to the standard protocol of adjuvant hypofractionated radiotherapy after breast conserving surgery, at a total dose of 40 Gy/ 15 fr (5 fr/ week, 3 consecutive weeks). In addition to the regular follow up, the patients will respond to the quality-of-life questionnaires (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC), general, QLQ- C30, and specific for breast (BR), QLQ- BR23, at the first visit, at the end of radiotherapy and at the subsequent follow-up visits from 6 months up to 5 and a half years, to evaluate the quality of life during and after the treatment.

The study also has a retrospective arm of approximately 3300 patients (number of patients and characteristics of disease expanded with the amendment presented to the Lombardia 1 Ethics Committee in May 22/2024), treated from January 2009, for whom disease control and toxicity will be evaluated.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Breast cancer patients with TNM Classification of Malignant Tumours pathological stage Tis-T4d, N0-N3, treated with surgery (conservative or mastectomy), accelerated partial breast irradiation or whole breast hypofractionated radiotherapy +/-SIB +/- regional lymph node irradiation Exclusion Criteria: \- male breast cancer patients

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Scientific Institute Milan MI

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03077191 on ClinicalTrials.gov ↗ ← All trials in Italy