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Trial record 1 of 1 for:    NCT04228991
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Hypofractionated LocoRegional Radiotherapy in Breast Cancer (RHEAL)

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ClinicalTrials.gov Identifier: NCT04228991
Recruitment Status : Recruiting
First Posted : January 14, 2020
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Radiotherapy Lymphedema Radiation: Locoregional radiation treatment - Conventional fractionation Radiation: Locoregional radiation treatment - Hypofractionation Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 588 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Hypofractionated LocoRegional Radiotherapy in Breast Cancer and Lymphedema (RHEAL)
Actual Study Start Date : February 10, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Conventional fractionation for locoregional radiotherapy
Radiation: Locoregional radiation treatment - Conventional fractionation
40 Gray in 15 daily fractions over 3 weeks

Experimental: Experimental
Hypofractionation for locoregional radiotherapy
Radiation: Locoregional radiation treatment - Hypofractionation
26 Gray in 5 daily fractions over 1 week




Primary Outcome Measures :
  1. Lymphedema [ Time Frame: 3 years post randomization ]
    Lymphedema defined as relative volume change (RVC) >10%


Secondary Outcome Measures :
  1. Breast cancer recurrence [ Time Frame: Annually for 5 years post randomization ]
    Both locoregional and distant recurrence and second cancers

  2. Mortality [ Time Frame: Annually for 5 years post randomization ]
    Survival

  3. Radiation toxicity [ Time Frame: During last week of radiotherapy, at 3 months post radiotherapy and annually for 5 years post randomization ]
    Acute and late radiation toxicity

  4. Arm mobility [ Time Frame: 1 and 3 years post randomization ]
    Assessed by measuring the straight lateral abduction of both the ipsilateral and contralateral arm

  5. Patient Quality of Life with respect to daily health and activities [ Time Frame: During last week of radiotherapy, at 3 months post radiotherapy and 1 and 3 years post randomization ]
    Impact on quality of life will be assessed with the European Organization for Research in Treatment of Cancer and the Breast Cancer Specific Module 23. The scale is 1 to 4 where a higher score means a worse outcome.

  6. Perception of lymphedema [ Time Frame: During last week of radiotherapy, at 3 months post radiotherapy and 1 and 3 years post randomization ]
    Impact of lymphedema on quality of life will be assessed with the National Surgical Adjuvant Breast and Bowel Project questionnaire. The scale is 1 to 5 where a higher score means a worse outcome.

  7. Perception of breast cosmesis [ Time Frame: 1 and 3 years post randomization ]
    Patient-reported breast cosmesis using a Breast Cosmesis Questionnaire to study the late effects of radiation.

  8. Health Care Resource Utilization [ Time Frame: During radiotherapy, at 3 months post radiotherapy and annually for 5 years post randomization ]
    Health Care Resource Utilization will be estimated using dates and duration of radiotherapy treatment and emergency department visits and hospitalizations.

  9. Patient Costs [ Time Frame: During last week of radiotherapy, at 3 months post radiotherapy and 1 and 3 years post randomization ]
    Patient costs will be assessed using a Time Off Work Questionnaire to study the financial impact of breast cancer and its treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Breast cancer stage after definitive surgery.

    • if neoadjuvant chemotherapy was not administered: pathologic stage T1-3, N1-2
    • if neoadjuvant chemotherapy was administered: clinical stage T1-3, N1-2 (histologically node positive) and pathologic stage T0-3, N0-2†

    Note: †Patients who are histologically node positive prior to chemotherapy and who have complete response in the lymph nodes are eligible.

  4. No evidence of metastatic disease.
  5. Candidate for locoregional radiotherapy.

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. Presence of known medical conditions that would preclude follow-up for 5 years.
  5. Synchronous or previous contralateral breast cancer.
  6. Breast reconstruction.
  7. History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma.
  8. 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.
  9. Known pregnancy or currently lactating.
  10. Geographic inaccessibility for follow-up.
  11. Inability to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228991


Contacts
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Contact: Kathryn Cline, BSc 905-527-2299 ext 42650 clinek@mcmaster.ca
Contact: Sharon Nason 905-527-2299 ext 42622 nasons@mcmaster.ca

Locations
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Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Sherry Qian         
Principal Investigator: Jeff Cao         
Canada, British Columbia
BC Cancer - Centre for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Julia Downey         
Principal Investigator: Jocelyn Moore         
BC Cancer - Vancouver Island Centre Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Contact: Emily White         
Principal Investigator: Tanya Berrang         
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Principal Investigator: Mira Goldberg         
Princess Margaret Cancer Centre - UHN Recruiting
Toronto, Ontario, Canada, M5G 1E0
Contact: Vicky Gillman         
Principal Investigator: Kathy Han         
Canada, Quebec
Hotel-Dieu de Lévis (CISSS CA) Recruiting
Lévis, Quebec, Canada, G6V 3Z1
Contact: Pierre Bedard         
Principal Investigator: Anne Dagnault         
McGill University Health Centre-Cedars Cancer Centre Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Marianna Perna         
Principal Investigator: Tarek Hijal         
CHU-de Québec-Université de Laval Recruiting
Quebec City, Quebec, Canada
Contact: Josee Allard         
Principal Investigator: Valerie Theberge         
Sherbrooke University Hospital Centre Recruiting
Sherbrooke, Quebec, Canada, J1G 2E8
Contact: Sophie Couture         
Principal Investigator: Sawyna Provencher         
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Investigators
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Principal Investigator: Timothy Whelan Juravinski Cancer Centre, McMaster University, Hamilton
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Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT04228991    
Other Study ID Numbers: OCOG-2019-RHEAL
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ontario Clinical Oncology Group (OCOG):
Hypofractionated
Locoregional
Breast Cancer
Lymphedema
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases