None listed
Conditions
Brief summary
This study aims to determine the best way of delivering radiation therapy to the breast tissue before surgery. In order to do that, women will lay in a prone position (on the stomach), so that the breast can fall naturally forward and away from the chest. The cancer inside the breast tissue is treated to a very high dose before it is removed. The aim is to minimise skin toxicities to help the surgeons perform the operation and reconstruction, all in one surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have a histologically confirmed invasive, Grade 1, 2 or 3 breast carcinoma with a Primary tumour graded as T2, T3 or T4 and N1+. Study details This study will take about 1 year to recruit 20 participants suitable for radiotherapy in the prone position. On average, the total study duration is expected to be 3 months for each participant. Radiotherapy treatment will commence at least 4 weeks after completion of standard chemotherapy and it will be delivered in the prone position, five days a week from Monday to Friday, over 5 weeks (25 fractions, 2Gy/fraction). One week before the radiotherapy treatment, the Radiotherapy Planning will be booked and the session will take approximately 1 hour. During the study, clinical assessments will be performed once a week during the treatment and then 2 and 4 weeks after radiotherapy completion. Each visit will take approximately 1 hour. 4-8 weeks following successful completion of radiotherapy participant will have a surgery to remove the breast and immediate breast reconstruction. 30 days after the surgery each patient will have their last study visit - post surgical assessment to evaluate any side effects and surgical complications. It is hoped that information from this study may help improve the treatment for other patients with invasive type of breast cancer in the future and will help evaluate the new position and treatment doses for future breast radiotherapy treatment.
Interventions
Study participant will need to be suitable for radiotherapy in the prone position assessed by a clinician. Radiotherapy treatment will take place at least 4 weeks after completion of chemotherapy and will be administered by radiotherapy team which includes radiation oncologist, radiation therapist, medical physicist and nurses.
Approximately 1 hour Planning Radiotherapy session will take place 1-2 weeks before the commencement of radiotherapy treatment. The plan will be audited by a second breas
Study participant will need to be suitable for radiotherapy in the prone position assessed by a clinician. Radiotherapy treatment will take place at least 4 weeks after completion of chemotherapy and will be administered by radiotherapy team which includes radiation oncologist, radiation therapist, medical physicist and nurses. Approximately 1 hour Planning Radiotherapy session will take place 1-2 weeks before the commencement of radiotherapy treatment. The plan will be audited by a second breast planner.Chart round review by the clinicians, physicists and radiation therapists. Radiotherapy in the Prone Position will be delivered five days a week from Monday to Friday over 5 weeks (25 fractions, 2Gy/fraction). Clinical assessments will be performed once a week during the treatment and then 2 and 4 weeks after radiotherapy completion. Each visit will take approximately 1 hour. Surgery to remove the breast and the immediate breast reconstruction will be performed 4-8 weeks after completion of radiotherapy. Post surgery clinical assessment will be performed by a surgeon approximately 30 days after the surgery. This will be the last study visit for each participant.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient has provided written informed consent for the trial Female patients greater than or equal 18 years of age on day of signing informed consent Patient has histologically confirmed invasive, Grade 1, 2 or 3 breast carcinoma Primary tumour is T2, T3 or T4 and N1+ Patient is a candidate for radiotherapy in the prone position and mastectomy with immediate autologous reconstruction as assessed by the breast surgeon, the plastic surgeon and the radiation oncologist Patient has received neoadjuvant systemic therapy, including chemotherapy and/or targeted therapies Patient ECOG Performance status of 0 or 1 Patient is willing and able to comply with the protocol requirements for the duration of the study including undergoing radiotherapy, surgery, scheduled visits and follow up
Exclusion criteria
Inflammatory breast cancers with documented skin involvement Presence of ductal carcinoma in situ (DCIS) alone Pregnant or lactating patients Contraindication to radiotherapy e.g. scleroderma Prior radiotherapy which precludes giving radiotherapy with curative intent to breast and locoregional nodes
Outcome results
None listed