Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy

N/ANot Yet RecruitingNCT06885671

British Columbia Cancer Agency60 enrolled

Overview

Partial Breast Irradiation (PBI) is a targeted radiation approach commonly administered post-lumpectomy, specifically targeting the tumour bed. This targeted therapy reduces the exposure to other nearby tissues such as lungs, heart, and chest wall. However, traditional PBI treatment involves lengthy multiple fraction courses which presents a burden to patients from rural and remote communities, who must travel long distances to receive high quality cancer care. The purpose of this study is to compare single fraction (SF) PBI vs. multiple fraction (MF) PBI.

Radiation can be delivered in multiple fractions, or doses, and can take up to several weeks or months of treatment depending on the type of cancer. Radiation can also be offered in a single fraction. Both techniques have evidence for use in clinical care. Multiple fraction is offered to reduce the amount of radiation given at a single time that could reduce late toxicities. However, single fraction radiotherapy is more cost-effective and saves patient time. With this trial, we will compare single fraction vs. multiple fraction PBI in regards to their impact on quality of life, rates of provider and participant reported toxicities, and local control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Eligibility

Sex: FEMALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female participants age 40 or older * Able to provide informed consent * pTis-2 pN0 cM0 breast cancer, with tumor size \<3 cm as per provincial guidelines * Able to complete electronic or paper entry of participant reported outcomes independently or with assistance from caregiver/family/friend/research staff * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 * A history and physical examination, including ECOG performance status, performed within 8 weeks prior to enrollment. * Participant is judged able to: * Maintain a stable position during therapy * Tolerate immobilization device(s) that may be required to deliver PBI safely * Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date Exclusion Criteria: * History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for ≥ 5 years. * Uncontrolled concurrent malignant cancer * Seroma not visible * Ipsilateral implanted cardiac device * Prior radiotherapy requiring summation for planning. * Inability to meet mandatory planning constraints. * Requirement for a radiation boost (as determined by the treating investigator) * Positive surgical margins * Surgical cavities lacking clear delineation (surgical clips are not required but may assist in target delineation) * Known germline BRCA1/2 mutation. * Serious medical comorbidities precluding radiotherapy (e.g., connective tissue disorders such as lupus or scleroderma) * Pregnant or breastfeeding

Outcomes

Primary Outcomes

Number of participants accrued

Number of participants who sign consent to be randomized to 1 vs 5 fractions of radiotherapy for PBI over a 2 year period

Time frame: 2 years

Secondary Outcomes

Time from CT simulation to plan approval

Measured as the time from the day of CT simulation to the date of plan approval.

Time frame: Baseline

2-Year Local Control Rates

Absence of ipsilateral in-breast recurrence, defined as histologic evidence of invasive or in situ breast cancer in the ipsilateral breast 2 years post-treatment

Time frame: 6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment

Quality of life assessed using the POSI-Breast questionnaire

Prospective Outcomes and Support Initiative (POSI) for Breast Data will be used to measure and compare the quality of life of participants in both arms.

Time frame: Baseline, 6 weeks, 6 months, 12 months, 18 months, and 24 months post treatment

Rates of provider-rated toxicities: Occurrences of adverse events as measured by CTCAE

Participant-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Data will be used to measure and compare participant-reported toxicities in both arms.

Time frame: Baseline, 6 weeks, 6 months, 12 months, 18 months, and 24 months post treatment

Participant-reported toxicities

Occurrences of adverse events as measured by PRO-CTCAE

Time frame: Baseline, 6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment

Overall Survival (OS)

Time from randomization to death from any cause, or last follow-up, whichever occurs first.

Time frame: Approximately at the end of year 2 (study completion)

Progression-Free Survival (PFS)

Time from randomization to disease progression at any site, death, or last follow-up, whichever occurs first.

Time frame: 6 weeks, 6 months, 12 months, 18 months, and approximately at the end of 24 months