Actively Recruiting

Phase 3
Age: 50Years - 120Years
FEMALE
NCT05417516

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

Led by Ontario Clinical Oncology Group (OCOG) · Updated on 2026-04-13

910

Participants Needed

28

Research Sites

414 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 120Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female with newly diagnosed invasive breast cancer without metastatic disease
  • Treated by breast-conserving surgery with clear resection margins of at least 1 mm or no residual disease on re-excision
  • Negative axillary node involvement confirmed by sentinel lymph node biopsy, axillary node dissection, or clinical assessment with negative ultrasound/biopsy for eligible tumors
Not Eligible

You will not qualify if you...

  • Age less than 50 years
  • Known BRCA 1 or BRCA 2 positive status
  • Tumor size greater than 3 cm on pathological exam
  • Extensive intraductal component involving at least 25% and extending beyond invasive tumor, except smaller tumors with combined invasive and DCIS size up to 3 cm
  • Ductal carcinoma in situ (DCIS) component larger than 3 cm
  • Lobular carcinoma only
  • More than one primary tumor in different quadrants of the same breast
  • Synchronous or previous cancer in the opposite breast, except contralateral DCIS or LCIS
  • History of non-breast cancer within last 5 years except treated non-melanoma skin cancer or treated in-situ carcinoma
  • Known pregnancy or currently breastfeeding
  • Inability to localize tumor bed on CT planning
  • Inability to plan for the experimental radiation technique

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 28 locations

1

GenesisCare Darlinghurst

Darlinghurst, New South Wales, Australia, 2010

Not Yet Recruiting

2

GenesisCare Hurstville

Hurstville, New South Wales, Australia, 2220

Actively Recruiting

3

GenesisCare Mater Hospital

North Sydney, New South Wales, Australia, 2060

Actively Recruiting

4

GenesisCare Bundaberg

Bundaberg, Queensland, Australia, 4670

Actively Recruiting

5

GenesisCare Southport

Southport, Queensland, Australia, 4215

Actively Recruiting

6

GenesisCare Tugun

Tugun, Queensland, Australia, 4224

Actively Recruiting

7

GenesisCare Hervey Bay

Urraween, Queensland, Australia, 4655

Actively Recruiting

8

GenesisCare St Andrew's

Adelaide, South Australia, Australia, 5000

Actively Recruiting

9

GenesisCare Wembley

Wembley, Washington, Australia, 6014

Actively Recruiting

10

GenesisCare Fiona Stanley Hospital

Murdoch, Western Austrailia, Australia, 6150

Actively Recruiting

11

GenesisCare Hollywood

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

12

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

Calgary, Alberta, Canada

Actively Recruiting

13

BCCA-Vancouver Island Cancer Centre

Victoria, British Columbia, Canada

Not Yet Recruiting

14

QEII HSC - Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Actively Recruiting

15

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Actively Recruiting

16

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Actively Recruiting

17

London Regional Cancer Centre

London, Ontario, Canada

Actively Recruiting

18

Stronach (Southlake) Regional Health Centre

Newmarket, Ontario, Canada

Actively Recruiting

19

Algoma District Cancer Program

Sault Ste. Marie, Ontario, Canada

Actively Recruiting

20

Princess Margaret Hospital

Toronto, Ontario, Canada

Actively Recruiting

21

Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre

Toronto, Ontario, Canada

Actively Recruiting

22

Windsor Regional Cancer Centre

Windsor, Ontario, Canada, N8W2X3

Actively Recruiting

23

CSSS Champlain - Charles LeMoyne

Greenfield Park, Quebec, Canada

Actively Recruiting

24

CHUM - Centre Hospitalier de L'Université de Montréal

Montreal, Quebec, Canada, H2L 4M1

Actively Recruiting

25

McGill University Health Centre

Montreal, Quebec, Canada

Actively Recruiting

26

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, Canada

Actively Recruiting

27

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

Trois-Rivières, Quebec, Canada, G8Z 3R9

Actively Recruiting

28

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada, S7N 4H4

Actively Recruiting

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Research Team

S

Shelley Chambers, MA

CONTACT

E

Erin McGean

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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