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Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy

ConditionBreast Cancer Early Stage Breast Cancer (Stage 1-3)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorBritish Columbia Cancer Agency

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multiple Fraction PBI

    Radiation

    Participants randomized to Arm 1 will receive PBI with a dose of 26 Gy in 5 daily fractions.

  • Single Fraction PBI

    Radiation

    Participants randomized to Arm 2 will receive PBI in a single fraction with a dose of 13 Gy.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Multiple Fraction PBI (Arm 1)Active comparator 1 intervention
Group B: Single Fraction PBI (Arm 2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

British Columbia Cancer Agency

Lead sponsor

Source ClinicalTrials.gov
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