Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy

British Columbia Cancer Agency

Status: Not yet enrolling

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

Treatments: Radiation: Multiple Fraction PBI; Radiation: Single Fraction PBI

Study type: Interventional

Funder types: Other

Identifiers

NCT06885671

SHIFT-PB

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Multiple Fraction PBI (Arm 1)

Active Comparator group

Description:

For participants randomized to Arm 1, PBI will be delivered with a dose of 26 Gy in 5 daily fractions.

Treatment:

Radiation: Multiple Fraction PBI

Single Fraction PBI (Arm 2)

Experimental group

Description:

For participants randomized to Arm 2, PBI will be delivered in a single fraction with a dose of 13 Gy.

Treatment:

Radiation: Single Fraction PBI