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

Breast Neoplasm Female | Radiotherapy | Cosmetic Outcome

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.

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Conditions de participation

  • Sexe:

    FEMALE

  • Âges admissibles:

    50 and up

Critères de participation

Inclusion Criteria:

For inclusion in this study, patients must fulfill all of the following criteria:

1. Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease.(AJCC TNM Cancer Staging).
2. Treated by BCS with microscopically clear resection margins ≥ 1mm for invasive and non-invasive disease or no residual disease on re-excision.
3. Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours \< 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy.

Exclusion Criteria:

Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:

1. Age less than 50 years.
2. Known to be BRCA 1 and/or BRCA 2 positive.
3. Tumour size \>3cm in greatest diameter on pathological examination.
4. Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are \<= 3cm remain eligible
5. Evidence of a DCIS component \> 3cm
6. Lobular carcinoma only.
7. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
8. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
9. History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
10. Known pregnancy or currently lactating.
11. Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
12. Inability to plan the patient for the experimental technique.

Lieu de l'étude

BCCA-Vancouver Island Cancer Centre
BCCA-Vancouver Island Cancer Centre
Victoria, British Columbia
Canada

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London Regional Cancer Centre
London Regional Cancer Centre
London, Ontario
Canada

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Backup Contact

Francisco Perera, MD

Primary Contact

Amanda Anderson

[email protected]
Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre
Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre
Toronto, Ontario
Canada

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Primary Contact

Clarissa Chau

[email protected]
CHUQ-Pavillon Hotel-Dieu de Quebec
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec
Canada

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Primary Contact

Josee Allard

[email protected]
Backup Contact

Valerie Theberge

Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit
Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit
Calgary, Alberta
Canada

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Primary Contact

Payal Thakker

[email protected]
Backup Contact

Marny Yar

[email protected]
Backup Contact

Jeffrey Cao

Juravinski Cancer Centre
Juravinski Cancer Centre
Hamilton, Ontario
Canada

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Backup Contact

Claire Howe

[email protected]
Primary Contact

Theresa Stokes

[email protected]
Backup Contact

Do-Hoon Kim

Princess Margaret Hospital
Princess Margaret Hospital
Toronto, Ontario
Canada

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Backup Contact

Jennifer Croke

Primary Contact

Jemima Macadangdang

[email protected]
McGill University Health Centre
McGill University Health Centre
Montréal, Quebec
Canada

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Backup Contact

Tarek Hijal

Backup Contact

Tatiana Carvalho

[email protected]
Primary Contact

Marianna Perna

[email protected]
QEII HSC - Nova Scotia Cancer Centre
QEII HSC - Nova Scotia Cancer Centre
Halifax, Nova Scotia
Canada

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Primary Contact

Maureen Nolan

Stronach (Southlake) Regional Health Centre
Stronach (Southlake) Regional Health Centre
Newmarket, Ontario
Canada

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Primary Contact

Rachel Woo

[email protected]
Backup Contact

Kendra

[email protected]
Backup Contact

Tatiana Conrad

Windsor Regional Cancer Centre
Windsor Regional Cancer Centre
Windsor, Ontario
Canada

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Backup Contact

Khalid Hirmiz, MD

Primary Contact

Donna Clinansmith

[email protected]
519-253-5253
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ)
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ)
Trois-Rivières, Quebec
Canada

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Backup Contact

Anne-Marie Taboika McMurray

[email protected]
Primary Contact

Marie-Eve Caron

[email protected]
819-697-3333
Backup Contact

Francois Vincent

Royal Victoria Regional Health Centre
Royal Victoria Regional Health Centre
Barrie, Ontario
Canada

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Primary Contact

Sujata Pokhrel

[email protected]
Backup Contact

Christine DiMarco

[email protected]
Backup Contact

Jessica Conway

Algoma District Cancer Program
Algoma District Cancer Program
Sault-Sainte-Marie, Ontario
Canada

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CSSS Champlain - Charles LeMoyne
CSSS Champlain - Charles LeMoyne
Greenfield Park, Quebec
Canada

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Primary Contact

Lorraine Menard

[email protected]
Backup Contact

Marjory Jolicoeur, MD

Saskatoon Cancer Centre
Saskatoon Cancer Centre
Saskatoon, Saskatchewan
Canada

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Étude parrainée par
Ontario Clinical Oncology Group (OCOG)
Participants recherchés
Plus d'informations
ID de l'étude: NCT05417516