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Optimisation and individualisation of HeartSparing breast radiotherapy techniques (The HeartSpare Study): Stage II

Optimisation and individualisation of HeartSparing breast radiotherapy techniques (The HeartSpare Study): Stage II multicentre, non-randomised intervention trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62239447
Enrollment
75
Registered
2013-04-26
Start date
2013-06-03
Completion date
Unknown
Last updated
2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Interventions

Radiotherapy using v_DIBH: Patients will receive their radiotherapy using the v_DIBH technique Study Entry : Registration only

Sponsors

Royal Marsden NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Percentage of patients in whom a reduction in mean LAD dose (Gy) is achieved with v_DIBH measured at end of study

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026