Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorUniversity Health Network, Toronto
About this trial
Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (\<13% grade \>3 toxicity).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive carcinoma)
Tumour <3.0 cm in greatest diameter on pathologic examination, including both invasive and non-invasive components
>5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted)
Disqualifiers
Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)
Tumour histology limited to lobular carcinoma only
T4 disease
Node positive or distant metastatic disease
Trial design
Design model
Single group
Treatments tested in this trial
rPBI
RadiationExternal beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week
Treatment groups
171 Participants
are divided into 1 treatment groupGroup A: rPBIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Grade ≥3 toxicity associated with treatment
TThe primary endpoint, grade ≥3 toxicity associated with treatment will be summarized using frequency and percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Time frame
During accrual period, up to 3 yearsSecondary outcomes
1
Frequency radiation-associated toxicity (acute)
Radiation-associated toxicities (acute) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using frequency with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Time frame
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI2
Percentage radiation-associated toxicity (acute)
Radiation-associated toxicities (acute) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Time frame
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI3
Frequency radiation-associated toxicity (late)
Radiation-associated toxicities (late) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using frequency with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Time frame
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI4
Percentage radiation-associated toxicity (late)
Radiation-associated toxicities (late) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up.
Time frame
3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBISponsors and contacts
Click on the lead sponsor to view all of their trials.
University Health Network, Toronto
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborator
Royal Victoria Regional Health Centre
Collaborator
AC Camargo Cancer Center
Collaborator
King Hussein Cancer Center
Collaborator
NYU Langone Health
Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator
Peter MacCallum Cancer Centre, Australia
Collaborator
CHU de Quebec-Universite Laval
Collaborator
Tel-Aviv Sourasky Medical Center
Collaborator
Virginia Commonwealth University
Collaborator
AOU Careggi
Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Maisonneuve-Rosemont Hospital
Collaborator
Columbia University
Collaborator
Lakeridge Health
Collaborator
London Health Sciences Centre
Collaborator
Clínica IRAM
Collaborator
University Malaysia Medical Centre
Collaborator
Aga Khan University
Collaborator
Source ClinicalTrials.gov