Hypofractionated LocoRegional Radiotherapy in Breast Cancer (RHEAL)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04228991 |
|
Recruitment Status :
Recruiting
First Posted : January 14, 2020
Last Update Posted : May 14, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Neoplasms Radiotherapy Lymphedema | Radiation: Locoregional radiation treatment - Conventional fractionation Radiation: Locoregional radiation treatment - Hypofractionation | Phase 3 |
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.
| 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 : | September 30, 2025 |
| Estimated Study Completion Date : | December 31, 2030 |
| 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 |
- Lymphedema [ Time Frame: 3 years post randomization ]Lymphedema defined as relative volume change (RVC) ≥10%
- Breast cancer recurrence [ Time Frame: Annually for 5 years post randomization ]Both locoregional and distant recurrence and second cancers
- Mortality [ Time Frame: Annually for 5 years post randomization ]Survival
- 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
- Arm mobility [ Time Frame: 1 and 3 years post randomization ]Assessed by measuring the straight lateral abduction of both the ipsilateral and contralateral arm
- 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.
- 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.
- 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.
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
- 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.
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
| Contact: Brittany Speller | 905-527-2299 ext 42611 | spelleb@mcmaster.ca | |
| Contact: Sharon Nason | 905-527-2299 ext 42622 | nasons@mcmaster.ca |
Show 19 study locations
| Principal Investigator: | Timothy Whelan | Juravinski Cancer Centre, McMaster University, Hamilton |
| 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: | May 14, 2024 |
| Last Verified: | May 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Hypofractionated Locoregional Breast Cancer Lymphedema |
|
Breast Neoplasms Lymphedema Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Lymphatic Diseases |