Ultra-hypofractionated Radiotherapy in Breast Cancer Patients
ConditionFemale Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-99
SponsorUniversity Of Perugia
About this trial
The present multicenter, retrospective and prospective observational study, aims to evaluate an ultra-hypofractionated whole breast irradiation schedule (WBI, 26 Gy in 5 fractions), in order to confirm literature data (FAST-F study) in the clinical practice.
Patient population included women affected by early stage breast cancer (BC), both invasive and ductal carcinoma in situ, receiving ultra-hypofractionated WBI (with or without a tumor bed boost) after breast conserving surgery (BCS). Main exclusion criteria are mastectomy and regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed. The primary otcome is acute and chronic toxicity evaluation. Secondary outcomes are: overall servival (OS), disease-free survival (DFS), rates of local and loco-regional recurrences, distant metastasis occurrence, cosmetic outcome and quality of life (QoL) assessment. Acute and late toxicities will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0. Cosmetic assessment will be graded according to the Harvard scale. Frontal photographs of both breasts will be used to evaluate toxicity and cosmetic results. For QoL assessment the EORTC (European Organisation for Research and Treatment of Cancer), QLQ-C30 and EORTC-QLQ-BR23 questionnaires will be administered.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients
Age ≥ 18 years.
Early stage breast cancer treated with breast conserving surgery
Whole breast irradiation without regional nodal irradiation
Disqualifiers
Age<18 years.
Regional nodal radiotherapy.
Distant metastases.
Previous history of malignancy except basaloid skin tumours and CIN. Previous history of breast cancer is not an exclusion criteria if treated with curative intent and if patient is disease free at least 5 years from diagnosis.
Trial population
Patients affected by early stage breast cancer (both invasive and ductal carcinoma in situ) receiving ultra-hypofractionated whole breast irradiation (with or without a tumor bed boost) after breast conserving surgery. Main exclusion critereria are mastectomy and regional nodal irradiation .Neoadjuvant and/or adjuvant systemic therapies are allowed.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
ultra-hypofractionated whole breast irradiation
RadiationAll enrolled patients will be treated with an ultra-ipofractionated whole breast irradiation schedule (26 Gy delivered in 5 consecutive fractions, single dose 5.2 Gy), according to FAST-Forward trial. Whole bresat irradiation should be followed or not by a tumor bed boost (sequential: 7.6 Gy in 2 consecutive fractions, single dose 3.8 Gy or simultaneous intergrated boost: 30 Gy in 5 consecutive fractions, single dose 6 Gy). Either three-dimensional conformal radiotherapy (3DCRT), intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT) or helicoildal techniques are allowed. Breath control techniques may be used at the discretion of each partecipating centre. Main exclusion critereria are mastectomy and regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Acute toxicity
Evaluation of acute toxicity to confirm the results obtained in the prospective randomized FAST-Forward study. Acute toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0
Time frame
1-6 months after RT2
Late toxicity
Evaluation of chronic late toxicity to confirm the results obtained in the prospective randomized FAST-Forward study. Late will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0
Time frame
from 6 months after RT to 60 monthsSecondary outcomes
1
overall survival
overall survival
Time frame
1 month after RT and then every 4-6 months for 5 years2
disease-free survival
disease-free survival
Time frame
1 month after RT and then every 4-6 months for 5 years3
rates of local and loco-regional recurrence
rates of local and loco-regional recurrence
Time frame
1 month after RT and then every 4-6 months for 5 years4
distant metastasis occurence
distant metastasis occurence
Time frame
1 month after RT and then every 4-6 months for 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov