Hypofractionated LocoRegional Radiotherapy in Breast Cancer
NCT ID: NCT04228991
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
588 participants
INTERVENTIONAL
2021-02-10
2030-12-31
Brief Summary
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Detailed Description
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Study participants will be assessed for lymphedema, the primary outcome, by measuring arm volume. Arm mobility will be assessed by measuring arm movement. Study participants will be assessed for acute and late radiation toxicities, during and post RT. Study participants will be followed and assessed annually for breast cancer recurrence (BCR), new second cancers, quality of life (QOL) and overall survival. Cost effectiveness and cost utility will also be determined. The planned sample size is 588 study participants. The study will be conducted at clinical centres throughout Canada.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Conventional fractionation for locoregional radiotherapy
Locoregional radiation treatment - Conventional fractionation
40 Gray in 15 daily fractions over 3 weeks
Experimental
Hypofractionation for locoregional radiotherapy
Locoregional radiation treatment - Hypofractionation
26 Gray in 5 daily fractions over 1 week
Interventions
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Locoregional radiation treatment - Conventional fractionation
40 Gray in 15 daily fractions over 3 weeks
Locoregional radiation treatment - Hypofractionation
26 Gray in 5 daily fractions over 1 week
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Ontario Clinical Oncology Group (OCOG)
OTHER
Responsible Party
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Principal Investigators
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Timothy Whelan, MD
Role: PRINCIPAL_INVESTIGATOR
Juravinski Cancer Centre, McMaster University, Hamilton
Locations
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Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer - Centre for the Southern Interior
Kelowna, British Columbia, Canada
BC Cancer - Centre for the North
Prince George, British Columbia, Canada
BC Cancer - Vancouver Centre
Vancouver, British Columbia, Canada
BC Cancer - Vancouver Island Centre
Victoria, British Columbia, Canada
Northeast Cancer Centre, Health Sciences North
Greater Sudbury, Ontario, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre - Odette Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Centre - UHN
Toronto, Ontario, Canada
Hotel-Dieu de Lévis (CISSS CA)
Lévis, Quebec, Canada
CIUSSS de l'Est-de-l'Île de Montréal, Hôpital, Maisonneuve-Rosemont
Montreal, Quebec, Canada
McGill University Health Centre-Cedars Cancer Centre
Montreal, Quebec, Canada
CHUM - Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada
CHU-de Québec-Université de Laval
Québec, Quebec, Canada
Sherbrooke University Hospital Centre
Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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OCOG-2019-RHEAL
Identifier Type: -
Identifier Source: org_study_id
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