Contact information
Type
Scientific
Primary contact
Dr Anna Kirby
ORCID ID
Contact details
The Royal Marsden NHS Foundation Trust
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
-
anna.kirby@rmh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11499
Study information
Scientific title
Optimisation and individualisation of heart-sparing breast radiotherapy techniques: a randomised controlled trial
Acronym
Study hypothesis
Single-centre randomised, non-blinded crossover trials investigating the impact of different heart-sparing breast radiotherapy techniques upon normal-tissue doses and upon reproducibility of patient position in women undergoing breast radiotherapy following excision of early breast cancer.
Hypotheses:
1. v_DIBH will be equivalent to ABC_DIBH in terms of dosimetric sparing of heart tissue, patient comfort, and set-up reproducibility, but at a reduced cost (due to the need for specialised equipment for ABC_DIBH)
2. Prone treatment is likely to be dosimetrically superior to optimal DIBH for the population of larger-breasted women
3. The optimal heart-sparing breast radiotherapy technique (DIBH versus prone positioning) will be individualisable to each patient based on their anatomical features
More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11499
Ethics approval
NRES Committee London Riverside, 25/01/2012, ref: 12/LO/0015
Study design
Randomised non-blinded interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
Study design:
These are single-centre non-blinded randomised cross-over trials (RCT) comparing i) treatment in voluntary deep inspiartor breath-hold (v_DIBH) versus Active Breathing Control deep inspiratory breath-hold (ABC_DIBH) in women of all breast volumes (Group A), and ii) treatment in DIBH versus prone position in women with larger breast volumes (>750cm3) (Group B). Within each cohort, patients will be randomised to start with one technique and to cross over to the other after 7 fractions.
Treatment planning: patient positioning and imaging:
All patients will receive training in holding their breath comfortably for up to 20 seconds. They will then undergo two radiotherapy planning CT scans. Patients in Group A will receive one scan in ABC_DIBH and a second scan in v_DIBH. Patients in Group B will undergo one scan in optimal DIBH (as determined by results from Group A) and one on their front (prone).
Treatment planning: study assessments:
1. 3D-CT planning scans in ABC_DIBH and v_DIBH (Group A)
2. 3D-CT planning scans in optimal DIBH and prone (Group B)
3. Scan times for each technique
4. Patient comfort and acceptability questionnaire following above scans
Treatment planning: target volume definition and radiotherapy planning:
Whole breast clinical target volume (WBCTV), contralateral breast tissue, lungs, heart, left anterior descending coronary artery (LAD) and ribcage will be outlined. For each technique, whole breast RT will be forward planned in 3D using multiple static opposed tangential fields, aiming to cover 90% of WBCTV with the 95% isodose, with hotspots ≥ 107cm3 limited to ≤ 2cm3. 40Gy in 15 fractions over 3 weeks will be prescribed to the 100% isodose (using 6-10MV photons).
During radiotherapy course: summary of study assessments
1. Daily EPI including cine-loop
2. Low dose CT verification imaging
3. Treatment times
4. Patient comfort and acceptability questionnaire
5. Radiographer satisfaction questionnaire
Follow-up assessments
No further investigations are required as part of the study following completion of radiotherapy. No long-term trial-related follow-up is required, although patients will be reviewed in the breast clinic as part of their standard follow-up.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
Group A: Reproducibility - interfraction reproducibility of patient position (mean daily displacements of chest wall) in v_DI
Secondary outcome measures
Group B: Difference in mean LAD NTDmean - difference in mean normal tissue dose (NTDmean) (Gy) to left anterior-descending coronary artery
Overall trial start date
01/02/2012
Overall trial end date
30/11/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Complete microscopic excision of early stage invasive ductal or lobular carcinoma (pT1-3b N0-1 M0) of the left breast following breast conservation surgery or mastectomy
2. Recommendation for whole breast (Group A and B) or chest wall radiotherapy (Group A only) (with or without tumour bed boost)
3. Age =18
4. Performance status =1
5. Patients able to tolerate breath-ho
6. Target Gender: Female
7. Lower Age Limit is 18 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 73; UK Sample Size: 73; Description: Group A: 23 patients; Group B: 50 patients
Participant exclusion criteria
1. Requirement for nodal irradiaion
2. Patients with micro- or macro-scopic disease on sentinel node biopsy who have not undergone completion axillary node clearance
3. Previous radiotherapy to any region above the diaphragm
Recruitment start date
01/02/2012
Recruitment end date
30/11/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Royal Marsden NHS Foundation Trust
Surrey
SM2 5PT
United Kingdom
Sponsor information
Organisation
The Royal Marsden Foundation Trust (UK)
Sponsor details
Institute of Cancer Research
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Research for Patient Benefit (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23726115
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25739317