Contact information
Type
Scientific
Primary contact
Dr Frederick Bartlett
ORCID ID
Contact details
Downs Road
Sutton
SM2 5PT
United Kingdom
+44 20 7352 8171
frederick.bartlett@rmh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14269
Study information
Scientific title
Optimisation and individualisation of HeartSparing breast radiotherapy techniques (The HeartSpare Study): Stage II multicentre, non-randomised intervention trial
Acronym
The HeartSpare Study (Stage II)
Study hypothesis
A multicentre non-randomised intervention trial investigating whether the roll-out of voluntary deep-inspiratory breath-hold (v_DIBH) in the context of a HTA-funded multicentre trial of breast radiotherapy fractionation (the FAST-Forward trial http://www.controlled-trials.com/ISRCTN19906132) confirms effective heart-sparing in women undergoing breast radiotherapy following excision of early breast cancer.
Ethics approval
NRES Committee London - Fulham, 18/02/2013, ref: 13/LO/0181
Study design
Multicentre non-randomised interventional trial; Design type: Treatment
Primary study design
Interventional
Secondary study design
Non randomised study
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
Radiotherapy using v_DIBH: Patients will receive their radiotherapy using the v_DIBH technique
Study Entry : Registration only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Percentage of patients in whom a reduction in mean LAD dose (Gy) is achieved with v_DIBH measured at end of study
Secondary outcome measures
1. Costs of techniques (equipment and time to scan/treat) measured at end of study
2. Difference in mean doses (Gy) to heart, ipsilateral lung and whole lungs, and maximum LAD dose measured at end of study
3. Interfraction reproducibility of patient position measured at end of study
4. Patient and radiographer satisfaction with positioning technique (questionnaire) measured at end of study.
5. Proportion of patients in whom prone position would have been optimal measured at end of study
6. Time spent in various activities / stages of treatment planning and delivery measured at end of study
Overall trial start date
03/06/2013
Overall trial end date
02/05/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women or men with left-sided breast cancer
2. Recommendation for whole breast or chest wall RT within FAST-Forward trial
3. Patients with any heart tissue in a tangential RT field placed according to standard anatomical borders
3. Any breast volume
4. Eastern Cooperative Oncology Group (ECOG) performance status <=1
5. Patients able to tolerate breath-hold
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 75; Description: 13 patients will be recruited from each of the five participating centres.
Participant exclusion criteria
1. Right-sided breast cancer
2. Ineligible for whole breast or chest wall RT within FAST-Forward trial
3. Patients with micro- or macro-scopic disease on sentinel node biopsy who have not undergone completion axillary node clearance
4. Previous radiotherapy to any region above the diaphragm
Recruitment start date
03/06/2013
Recruitment end date
02/05/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Downs Road
Sutton
SM2 5PT
United Kingdom
Sponsor information
Organisation
Royal Marsden NHS Foundation Trust (UK)
Sponsor details
Downs Road
Sutton
SM2 5PT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme ref: PB-PG-1010-23003
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
Results - basic reporting
Publication summary