Condition category
Cancer
Date applied
24/04/2013
Date assigned
26/04/2013
Last edited
29/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Frederick Bartlett

ORCID ID

Contact details

Downs Road
Sutton
SM2 5PT
United Kingdom
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.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=14269

Ethics approval

NRES Committee London - Fulham, First MREC approval date 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 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

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

http://www.royalmarsden.nhs.uk/

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

Publication citations

Additional files

Editorial Notes