Condition category
Cancer
Date applied
06/02/2012
Date assigned
06/02/2012
Last edited
29/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23726115
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25739317

Publication citations

Additional files

Editorial Notes

29/02/2016: Publication references added.