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Trial Title:
External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients
NCT ID:
NCT06224244
Condition:
Breast Neoplasms
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
simultaneous integrated boost
hypofractionated radiotherapy
whole breast radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Two test groups. A Simultaneous integrated boost to 40 Gy (SIB 40): 34 Gy to the
ipsilateral breast with concomitant boost to 40 Gy to the tumor bed. A Simultaneous
integrated boost to 43 Gy (SIB 43): 34 Gy to the ipsilateral breast with concomitant
boost to 43 Gy to the tumor bed
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost
Description:
Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a
risk adapted SIB dose of 40 Gy
Arm group label:
Simultaneous integrated boost to 40 Gy (SIB 40)
Other name:
SIB40
Intervention type:
Radiation
Intervention name:
Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost
Description:
Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a
risk adapted SIB dose of 43 Gy
Arm group label:
Simultaneous integrated boost to 43 Gy (SIB 43)
Other name:
SIB43
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
Detailed description:
Patients enrolled for the study, according to eligibility criteria, undergo breast
conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk
adapted simultaneous-integrated boost dose at the level of the tumour bed according to
clinical and pathological risk factors.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Regina Elena Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Silvia Takanen
Phone:
+39065266
Email:
silvia.takanen@ifo.it
Investigator:
Last name:
Silvia Takanen
Email:
Principal Investigator
Start date:
February 1, 2022
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06224244
