Partial Breast Re-irradiation Using Ultra Hypofractionation: Phase 2 Multi-institutional Study (PRESERVE)

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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)

• Clinically node negative

• Negative margins (no tumour on ink)

• Recovered from surgery with the incision completely healed and no signs of infection

Locations
United States
New York
Columbia University Medical Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Virginia
Virgina Community University Massey Comprehensive Cancer Center
RECRUITING
Richmond
Other Locations
Australia
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Brazil
A.C.Camargo Cancer Center
RECRUITING
São Paulo
Canada
Royal Victoria Regional Health Centre
RECRUITING
Barrie
Verspeeten Family Cancer Centre
RECRUITING
London
Centre hospitalier de l'Université de Montréal
RECRUITING
Montreal
CHU de Québec-Université Laval
RECRUITING
Montreal
Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal
RECRUITING
Montreal
Odette Cancer Centre
RECRUITING
Toronto
Princess Margaret Cancer Centre
RECRUITING
Toronto
Israel
Tel-Aviv Sourasky Medical Centre
RECRUITING
Tel Aviv
Italy
Florence University Hospital
RECRUITING
Florence
Jordan
King Hussein Cancer Centre
RECRUITING
Amman
Contact Information
Primary
Danielle Rodin, MD
danielle.rodin@uhn.ca
(416) 946-6513
Backup
Anne Koch, MD
anne.koch@uhn.ca
(416) 946-2919
Time Frame
Start Date: 2023-06-27
Estimated Completion Date: 2027-06-27
Participants
Target number of participants: 171
Treatments
Experimental: rPBI
26Gy in 5 daily fractions over 1-week
Related Therapeutic Areas
Sponsors
Collaborators: l'Hopital Maisonneuve-Rosemont, CHU de Quebec-Universite Laval, Tata Memorial Hospital, Centre hospitalier de l'Université de Montréal (CHUM), Peter MacCallum Cancer Centre, Australia, Sunnybrook Health Sciences Centre, King Hussein Cancer Center, AC Camargo Cancer Center, Tel-Aviv Sourasky Medical Center, NYU Langone Health, Royal Victoria Regional Health Centre, Florence University Hospital, Virginia Commonwealth University, L'Institut de recherche du Centre universitaire de sante McGill
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov