Hypofractionated LocoRegional Radiotherapy in Breast Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    588
  • sponsor
    Ontario Clinical Oncology Group (OCOG)
Updated on 2 May 2021

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 Radiation Oncology, Lymphedema, Breast Cancer, Radiotherapy, radiotherapeutic, lymphoedema, breast tumors, tumor of the breast, breast tumor
Treatment Locoregional radiation treatment - Conventional fractionation, Locoregional radiation treatment - Hypofractionation
Clinical Study IdentifierNCT04228991
SponsorOntario Clinical Oncology Group (OCOG)
Last Modified on2 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: breast tumor or Lymphedema or Radiotherapy or Radiation Oncology or Breast Cancer or tumor of the breast or lymphoedema or breast tumors or radiothera...?
Do you have any of these conditions: Radiotherapy or Radiation Oncology or tumor of the breast or Lymphedema or lymphoedema or breast tumors or breast tumor or radiotherapeutic or Breast ...?
Do you have any of these conditions: breast tumor or Radiation Oncology or Breast Cancer or lymphoedema or tumor of the breast or Radiotherapy or breast tumors or radiotherapeutic or Lymp...?
Do you have any of these conditions: Radiotherapy or Radiation Oncology or breast tumors or radiotherapeutic or Lymphedema or tumor of the breast or breast tumor or lymphoedema or Breast ...?
Do you have any of these conditions: breast tumors or Radiotherapy or Breast Cancer or tumor of the breast or lymphoedema or breast tumor or Radiation Oncology or Lymphedema or radiothera...?
Do you have any of these conditions: radiotherapeutic or Radiotherapy or breast tumors or tumor of the breast or lymphoedema or Lymphedema or breast tumor or Radiation Oncology or Breast ...?
Do you have any of these conditions: Radiotherapy or Lymphedema or lymphoedema or Radiation Oncology or breast tumor or tumor of the breast or breast tumors or radiotherapeutic or Breast ...?
Do you have any of these conditions: tumor of the breast or Radiotherapy or Radiation Oncology or radiotherapeutic or breast tumors or lymphoedema or Breast Cancer or Lymphedema or breast...?
Do you have any of these conditions: lymphoedema or radiotherapeutic or Breast Cancer or breast tumor or Radiation Oncology or Lymphedema or Radiotherapy or breast tumors or tumor of the ...?
Do you have any of these conditions: tumor of the breast or Radiation Oncology or breast tumor or Lymphedema or Radiotherapy or breast tumors or radiotherapeutic or Breast Cancer or lymph...?
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
\. 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
\. No evidence of metastatic disease
\. Candidate for locoregional radiotherapy

Exclusion Criteria

Age < 18 years
Clinical stages T4 and/or N3
Clinical lymphedema in the ipsilateral arm or breast/chest wall
Synchronous or previous contralateral breast cancer
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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