None listed
Conditions
Brief summary
This study aims to determine the incidence of breast oedema following whole breast radiotherapy using an objective measure of TDC measurements, to determine the difference, if any, between a moderately hypofractionated radiation schedule and an accelerated ultra-hypofractionated schedule. Who is it for? You may be eligible for this study if you are a woman aged 50 years or older and have been diagnosed with breast cancer. Study details Participants will be randomised to one of two possible treatments: the current standard of care of "moderate hypofractionation" treatment, as 40.05 Gy in 15 fractions as daily treatment sessions for 15-19 consecutive days; or " ultra-hypofractionation" treatment, as 26 Gy in 5 fractions to the whole breast, delivered in 5 sessions over 5-9 days. A tumour bed boost is an optional component of both treatments. Participants will be followed for 60 months after the treatment to determine post-radiotherapy breast changes, such as swelling and oedema, quality of life and other patient reported outcomes. It is hoped that this research will help to improve the safety, patient experience, and efficacy of breast cancer treatment.
Interventions
The study is enrolling 200 patients.
If the patient meets the inclusion criteria of the study as per radiation oncologist they can be randomised onto the study via an electronic system.
There is a 50/50 chance of being randomised into either arm of the study. Radiotherapy treatment could either be 5-9 or 15-19 days.
In the shorter course arm, patients will receive radiotherapy delivered by radiation therapists at Gosford Hospital at a dose of 26.0Gy in five fractions with an optional tumour
The study is enrolling 200 patients. If the patient meets the inclusion criteria of the study as per radiation oncologist they can be randomised onto the study via an electronic system. There is a 50/50 chance of being randomised into either arm of the study. Radiotherapy treatment could either be 5-9 or 15-19 days. In the shorter course arm, patients will receive radiotherapy delivered by radiation therapists at Gosford Hospital at a dose of 26.0Gy in five fractions with an optional tumour bed boost (This optional boost is decided by the Radiation Oncologist). This tumour bed boost can be given simultaneously as 30Gy in five fractions or sequentially as 10Gy in four fractions. The overall duration of the intervention is over 5-9 days.
Sponsors
Gosford Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Women aged 50 years or older 2. Unilateral DCIS or early-stage invasive breast cancer (Stage Tis-T3, N0, M0) 3. Breast conservation surgery 4. Complete microscopic resection i.e. negative margins 5. Neoadjuvant systemic therapy to downstage cT3-T4 breast cancer is accepted if there is not an indication to irradiate the lymph nodes or treat with bolus 6. Ability to understand and willingness to sign written informed consent 7. Available for 2 years of face-to face follow-up
Exclusion criteria
1. Prior history of breast cancer or DCIS 2. Bilateral breast cancer or bilateral breast surgery (e.g. symmetrising surgery) 3. History of breast implants or breast reconstructive surgery in either breast 4. Use of bolus during radiotherapy 5. Prone breast radiation treatment 6. Conditions where the patient cannot complete radiation treatment or attend follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial e.g. language problems. 7. Unwilling or unable to give informed consent
Outcome results
None listed