Hypofractionated LocoRegional Radiotherapy in Breast Cancer

NCT04228991 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: OCOG-2019-RHEAL
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 20

Brief Summary

The 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.

Conditions

Breast Neoplasms; Radiotherapy; Lymphedema

Keywords

Hypofractionated; Locoregional; Breast Cancer; Lymphedema

Outcome Measures

Primary Outcomes (1)

• Lymphedema

  Lymphedema defined as relative volume change (RVC) ≥10%

  3 years post randomization

Secondary Outcomes (9)

• Breast cancer recurrence

  Annually for 5 years post randomization

• Mortality

  Annually for 5 years post randomization

• Radiation toxicity

  During last week of radiotherapy, at 3 months post radiotherapy and annually for 5 years post randomization

• Arm mobility

  1 and 3 years post randomization

• Patient Quality of Life with respect to daily health and activities

  During last week of radiotherapy, at 3 months post radiotherapy and 1 and 3 years post randomization

Study Arms (2)

Control

ACTIVE COMPARATOR

Conventional fractionation for locoregional radiotherapy

Radiation: Locoregional radiation treatment - Conventional fractionation

Experimental

EXPERIMENTAL

Hypofractionation for locoregional radiotherapy

Radiation: Locoregional radiation treatment - Hypofractionation

Interventions

Locoregional radiation treatment - Conventional fractionation RADIATION

40 Gray in 15 daily fractions over 3 weeks

Control

Locoregional radiation treatment - Hypofractionation RADIATION

26 Gray in 5 daily fractions over 1 week

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed invasive carcinoma of the breast.
• 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.
• 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.
• No evidence of metastatic disease.

You may not qualify if:

• Age \< 18 years.
• Clinical stages T4 and/or N3.
• Clinical lymphedema in the ipsilateral arm or breast/chest wall.
• 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.)
• Synchronous or previous contralateral breast cancer.(Patients with previous contralateral DCIS or LCIS not treated with radiation are eligible.)
• History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma.
• Neoadjuvant endocrine therapy. (Extended neoadjuvant endocrine therapy is not permitted. Endocrine therapy exposure for 12 weeks or less prior to surgery is acceptable.)
• Breast reconstruction.
• Presence of known medical conditions that would preclude follow-up for 5 years.
• 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.
• Known pregnancy or currently lactating.
• Geographic inaccessibility for follow-up.
• Inability to provide informed consent.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead

Study Sites (20)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BC Cancer - Centre for the North

Prince George, British Columbia, Canada

Location

BC Cancer - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BC Cancer - Vancouver Island Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

Northeast Cancer Centre, Health Sciences North

Greater Sudbury, Ontario, P3E5J1, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre - Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre - UHN

Toronto, Ontario, M5G 1E0, Canada

Location

Hotel-Dieu de Lévis (CISSS CA)

Lévis, Quebec, G6V 3Z1, Canada

Location

CIUSSS de l'Est-de-l'Île de Montréal, Hôpital, Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University Health Centre-Cedars Cancer Centre

Montreal, Quebec, H4A 3J1, Canada

Location

CHUM - Centre Hospitalier de L'Universite de Montreal

Montreal, Quebec, Canada

Location

CHU-de Québec-Université de Laval

Québec, Quebec, Canada

Location

Sherbrooke University Hospital Centre

Sherbrooke, Quebec, J1G 2E8, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Timothy Whelan, MD

  Juravinski Cancer Centre, McMaster University, Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 14, 2020
• Study Start: February 10, 2021
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 18, 2025

Record last verified: 2025-07

Locations

CA (20)