Hypofractionated LocoRegional Radiotherapy in Breast Cancer
Breast Neoplasms | Lymphedema | RadiotherapyThe primary objective of this study is to determine if hypofractionated RT delivered over 1 week to the breast or chest wall and regional nodes (26Gy in 5 daily fractions) following BCS or mastectomy, is non-inferior to conventional fractionation to the breast or chest wall and regional nodes delivered over 3 weeks (40Gy in 15 daily fractions) in patients with node-positive breast cancer.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
1. Newly diagnosed invasive carcinoma of the breast.
2. Treated with definitive surgery (BCS or mastectomy with nodal staging using SLNB or ALND) with clear margins of excision.\* Note: \*Patients with limited positive posterior margin where disease is resected to chest wall or limited positive anterior margin where disease is resected to dermis are eligible.
3. Candidate for locoregional radiotherapy: breast cancer stage after definitive surgery:
* Neoadjuvant chemotherapy was not administered: pathologic stage T3N0,T1-3 N1-2\*\*
\*\* patients with nodal micromets (N1mi) are eligible
* Neoadjuvant chemotherapy was administered: clinical stage T3N0, T1-3, N1-2 and pathologic stage T0-3, N0-2†
* Patients who are clinically N1-2 prior to chemotherapy should be confirmed histologically unless it is clear that they are node positive. Patients who are deemed node negative prior to chemotherapy but are node positive following chemotherapy are eligible. Patients who are node positive prior to chemotherapy and who have complete response in the lymph nodes are also eligible.
4. No evidence of metastatic disease.
Exclusion Criteria:
1. Age \< 18 years.
2. Clinical stages T4 and/or N3.
3. Clinical lymphedema in the ipsilateral arm or breast/chest wall.
4. Any prior history, not including index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with previous ipsilateral DCIS or LCIS not treated with radiation are eligible.)
5. Synchronous or previous contralateral breast cancer.(Patients with previous contralateral DCIS or LCIS not treated with radiation are eligible.)
6. History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma.
7. Neoadjuvant endocrine therapy. (Extended neoadjuvant endocrine therapy is not permitted. Endocrine therapy exposure for 12 weeks or less prior to surgery is acceptable.)
8. Breast reconstruction.
9. Presence of known medical conditions that would preclude follow-up for 5 years.
10. Previous radiotherapy to the ipsilateral breast or chest wall or serious non-malignant disease e.g. scleroderma, severe lung or heart disease that would preclude radiotherapy.
11. Known pregnancy or currently lactating.
12. Geographic inaccessibility for follow-up.
13. Inability to provide informed consent.
Study Location
Cross Cancer Institute
Cross Cancer InstituteEdmonton, Alberta
Canada
Contact Study Team
Juliette Jordan
Fleur Huang
BC Cancer - Vancouver Island Centre
BC Cancer - Vancouver Island CentreVictoria, British Columbia
Canada
Contact Study Team
Tanya Berrang
Lily Hallett Rio
Northeast Cancer Centre, Health Sciences North
Northeast Cancer Centre, Health Sciences NorthSudbury, Ontario
Canada
Contact Study Team
Jacqueline Lam
Amanda Snyder
CIUSSS de l'Est-de-l'Île de Montréal, Hôpital, Maisonneuve-Rosemont
CIUSSS de l'Est-de-l'Île de Montréal, Hôpital, Maisonneuve-RosemontMontreal, Quebec
Canada
Contact Study Team
Michael Yassa, MD
Lys Fernet
Sherbrooke University Hospital Centre
Sherbrooke University Hospital CentreSherbrooke, Quebec
Canada
Contact Study Team
Tom Baker Cancer Centre
Tom Baker Cancer CentreCalgary, Alberta
Canada
Contact Study Team
Jeff Cao
Marny Yar
BC Cancer - Vancouver Centre
BC Cancer - Vancouver CentreVancouver, British Columbia
Canada
Contact Study Team
Ketki Merchant
Alan Nichol
The Ottawa Hospital Regional Cancer Centre
The Ottawa Hospital Regional Cancer CentreOttawa, Ontario
Canada
Contact Study Team
Krista Liimatainen
Lynn Chang
Hotel-Dieu de Lévis (CISSS CA)
Hotel-Dieu de Lévis (CISSS CA)Lévis, Quebec
Canada
Contact Study Team
Pierre Bedard
Anne Dagnault
CHU-de Québec-Université de Laval
CHU-de Québec-Université de LavalQuebec City, Quebec
Canada
Contact Study Team
Josee Allard
Valerie Theberge
BC Cancer - Centre for the Southern Interior
BC Cancer - Centre for the Southern InteriorKelowna, British Columbia
Canada
Contact Study Team
Angela Lin
Kiana Wong
Juravinski Cancer Centre
Juravinski Cancer CentreHamilton, Ontario
Canada
Contact Study Team
Brenda DeMedeiros
Tim Whelan
Sunnybrook Health Sciences Centre - Odette Cancer Centre
Sunnybrook Health Sciences Centre - Odette Cancer CentreToronto, Ontario
Canada
Contact Study Team
Clarissa Chau
Eileen Rakovitch
McGill University Health Centre-Cedars Cancer Centre
McGill University Health Centre-Cedars Cancer CentreMontréal, Quebec
Canada
Contact Study Team
Marianna Perna
Tarek Hijal
Allan Blair Cancer Centre
Allan Blair Cancer CentreRegina, Saskatchewan
Canada
Contact Study Team
Derek Suderman
Bernadette Procyk
BC Cancer - Centre for the North
BC Cancer - Centre for the NorthPrince George, British Columbia
Canada
Contact Study Team
Robert Olson, MD
London Regional Cancer Program
London Regional Cancer ProgramLondon, Ontario
Canada
Contact Study Team
Francisco Perera
Alisha Moynahan
Princess Margaret Cancer Centre - UHN
Princess Margaret Cancer Centre - UHNToronto, Ontario
Canada
Contact Study Team
Kathy Han
Vicky Gillman
CHUM - Centre Hospitalier de L'Universite de Montreal
CHUM - Centre Hospitalier de L'Universite de MontrealMontréal, Quebec
Canada
Contact Study Team
Pierre Rousseau
Mom Phat
Saskatoon Cancer Centre
Saskatoon Cancer CentreSaskatoon, Saskatchewan
Canada
Contact Study Team
Shavaun Liss
Philip Wright
- Study Sponsored By
- Ontario Clinical Oncology Group (OCOG)
- Participants Required
- More Information
- Study ID:
NCT04228991