RecruitingPhase 3NCT05417516

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

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

Sponsor

Ontario Clinical Oncology Group (OCOG)

Enrollment

910 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasm Female Radiotherapy Cosmetic Outcome

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.

Eligibility

Sex: FEMALEMin Age: 50 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a shorter, more convenient radiation treatment schedule for early-stage breast cancer — just 5 treatments (fractions) delivered to only the part of the breast where the tumor was removed, rather than the whole breast. This approach is called partial breast irradiation, and the goal is to show it works just as well with fewer visits. **You may be eligible if...** - You are a woman with a new diagnosis of invasive breast cancer with no signs of spread - You had breast-conserving surgery (lumpectomy) with clear margins - Your tumor was small (typically less than 3 cm) and lymph node negative - You are 40 years of age or older **You may NOT be eligible if...** - You have cancer in multiple areas of the breast - You have inflammatory breast cancer or cancer that has spread to lymph nodes - You are pregnant - You have had prior radiation to the chest - Your tumor has specific high-risk features (e.g., certain genetic profiles) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONWhole 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).

RADIATIONPartial 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05417516

Related Trials

Measuring Fluid Buildup in Cancer Patients

NCT074436181 location

Nutritional Status of Head and Neck Cancer Patients

NCT070687111 location

Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.

NCT073874452 locations

Spatially Fractionated Radiotherapy Combined With Immunotherapy for Advanced Solid Tumors

NCT070589483 locations

Virtual Vs Telephone Education in Radiotherapy

NCT072551961 location