Hypofractionated LocoRegional Radiotherapy in Breast Cancer (RHEAL)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    588
  • sponsor
    Ontario Clinical Oncology Group (OCOG)
Updated on 5 June 2022
cancer
carcinoma
breast cancer
mastectomy
breast cancer staging
breast-conserving surgery
invasive carcinoma

Summary

The primary objective is to determine if hypofractionated radiotherapy (RT) delivered over 1 week to the breast and regional nodes (supraclavicular, axillary and internal mammary) following breast conserving surgery (BCS), or to the chest wall and regional nodes following mastectomy, is non-inferior to conventional fractionation delivered over 3 weeks in patients with node positive breast cancer.

Description

A multi-centre, randomized, non-inferior, phase III study comparing two radiation treatment modalities, conventional fractionation with hypofractionation for locoregional RT. Eligible, consenting patients with newly diagnosed and histologically confirmed invasive carcinoma of the breast without evidence of metastatic disease; treated with definitive surgery [BCS or mastectomy with nodal staging using sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)] will be randomized in a 1:1 fashion to either conventional locoregional RT (control group) or hypofractionated locoregional RT (experimental group). Stratification factors include: body mass index, the performance of ALND, type of surgery (BCS or mastectomy) and clinical centre.

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.

Details
Condition Breast Neoplasms, Radiotherapy, Lymphedema
Treatment Locoregional radiation treatment - Conventional fractionation, Locoregional radiation treatment - Hypofractionation
Clinical Study IdentifierNCT04228991
SponsorOntario Clinical Oncology Group (OCOG)
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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