Active, not recruiting
Phase 2
External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients
Condition(s) studied
Breast NeoplasmsBreast Cancer
Investigational drug(s) / intervention(s)
Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boostTen-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost
Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost: Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 40 Gy
Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost: Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy
Study summary
This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer
Eligibility
Inclusion Criteria:
* Histologically proven invasive or in situ unifocal adenocarcinoma of the breast
* Breast conserving surgery
* Pathological pTis G3, pT1-2 any Grade, pN0 or pN0(sn) (isolated tumor cells \[i+\] allowed) pN1mic, M0 stage
* Postoperative negative (no ink) final surgical margins
* Patient requires a whole breast radiotherapy plus a tumor bed boost
* Female patients aged ≥ 18 years of any menopausal status
* ECOG performance status 0-2
Exclusion Criteria:
* Past history of malignancy except basal cell skin cancer and CIN cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free
* Mastectomy
* Concomitant chemotherapy (primary or sequential chemotherapy allowed) (Chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (Patients receiving neo-adjuvant chemotherapy are not excluded)
* Known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma
* Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder
* Pregnant or lactating patients
* Presence of ipsilateral breast implant
* Prior breast or thoracic radiotherapy for any condition
Primary outcome measure(s)
- Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale — From the end of treatment at 3 years
Incidence of grade 2-3 late toxicity in terms of skin toxicity
Trial sites (1)
| Facility | City | Region | Status |
| Regina Elena Cancer Institute |
Rome |
Lazio |
|
More Regina Elena Cancer Institute trials in Italy
Other trials for the same condition