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RECRUITING
NCT05417516
PHASE3

A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)

Sponsor: Ontario Clinical Oncology Group (OCOG)

View on ClinicalTrials.gov

Summary

The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.

Official title: A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)

Key Details

Gender

FEMALE

Age Range

50 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

910

Start Date

2023-11-20

Completion Date

2031-11

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

RADIATION

Whole Breast Irradiation (WBI)

The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).

RADIATION

Partial Breast Irradiation (PBI)

The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).

Locations (28)

GenesisCare Darlinghurst

Darlinghurst, New South Wales, Australia

GenesisCare Hurstville

Hurstville, New South Wales, Australia

GenesisCare Mater Hospital

North Sydney, New South Wales, Australia

GenesisCare Bundaberg

Bundaberg, Queensland, Australia

GenesisCare Southport

Southport, Queensland, Australia

GenesisCare Tugun

Tugun, Queensland, Australia

GenesisCare Hervey Bay

Urraween, Queensland, Australia

GenesisCare St Andrew's

Adelaide, South Australia, Australia

GenesisCare Wembley

Wembley, Washington, Australia

GenesisCare Fiona Stanley Hospital

Murdoch, Western Austrailia, Australia

GenesisCare Hollywood

Nedlands, Western Australia, Australia

Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit

Calgary, Alberta, Canada

BCCA-Vancouver Island Cancer Centre

Victoria, British Columbia, Canada

QEII HSC - Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

London Regional Cancer Centre

London, Ontario, Canada

Stronach (Southlake) Regional Health Centre

Newmarket, Ontario, Canada

Algoma District Cancer Program

Sault Ste. Marie, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre

Toronto, Ontario, Canada

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

CSSS Champlain - Charles LeMoyne

Greenfield Park, Quebec, Canada

CHUM - Centre Hospitalier de L'Université de Montréal

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, Canada

Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ)

Trois-Rivières, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada