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The HeartSpare Plus 1B Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02771353
Recruitment Status : Unknown
Verified May 2016 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
This study aims to compare the resource impact, acute toxicity and feasibility of different pan-lymph node radiotherapy techniques. Radiotherapy using wide tangents with the patient in breath hold will be compared against volumetric modulated arc therapy (VMAT) in free breathing in the main trial. A parallel study will asses the accuracy of VMAT treatments using voluntary deep inspiratory breath hold compared to an active breathing controlled breath hold device.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: WT_vDIBH Radiation: VMAT_FB Phase 2

Detailed Description:
Following publication of results of two large randomised clinical trials, pan-lymph node radiotherapy (pan-LN RT) (including treatment of the internal mammary chain) is set to become standard treatment in patients with lymph-node positive breast cancer. Traditional pan-LN RT techniques deliver high radiation doses to the heart and lungs which can cause long-term side-effects in women many years after their treatment. Modern techniques including breath-holding and volumetric-modulated arc therapy (VMAT) can reduce doses to heart and lungs but the investigators do not yet know which technique(s) are best in terms of resource costs, short to medium-term side-effects, and day to day accuracy. This study will compare the time taken to deliver pan-LN RT using breath-holding versus VMAT and will collect side-effect data up to one year following treatment as well as modelling long-term cardiac risks based on heart doses delivered. The results of the main study will help guide clinicians and departments in selecting the best pan-LN RT techniques for their patients. A parallel study will evaluate the combination of breath-hold and VMAT using a machine-based technique called the active-breathing controlled (ABC) device against a more simple voluntary breath-hold technique were patients simply take a breath in and hold it for up to 20 seconds at a time. These techniques will be compared in terms of their day-to-day accuracy. If the simpler technique proves as accurate as the ABC-technique, this will establish the simpler technique as a less resource-intensive standard of care adoptable by other radiotherapy departments.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The HeartSpare Plus 1B Trial: A Randomised Phase II Trial Comparing the Resource Impact, Acute Toxicity and Feasibility of Different Pan-lymph Node Radiotherapy Techniques for Breast Cancer Patients
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: WT_vDIBH
Wide tangent radiotherapy in voluntary deep inspiratory breath hold
Radiation: WT_vDIBH
Active Comparator: VMAT_FB
Volumetric modulated arc therapy in free breathing.
Radiation: VMAT_FB

Primary Outcome Measures :
  1. Linear Accelerator time [ Time Frame: 3 weeks ]
    Patient mounting couch to linear accelerator being turned off

Secondary Outcome Measures :
  1. Acute toxicity - Skin [ Time Frame: 5 weeks ]
    CTCAE grading

  2. Acute toxicity - lung (pneumonitis) [ Time Frame: 5 weeks ]
    CTCAE grading

  3. Acute toxicity - oesophagitis [ Time Frame: 5 weeks ]
    CTCAE grading

  4. Acute toxicity - fatigue [ Time Frame: 5 weeks ]
    EORTC QLQ-C30 + FA13

  5. Acute toxicity - quality of life [ Time Frame: 5 weeks ]
    EORTC QLQ-C30 + BR23

  6. Intermediate toxicity - lung (pneumonitis) [ Time Frame: up to 1 year ]
    CTCAE pneumonitis assesment

  7. Intermediate toxicity - fatigue [ Time Frame: up to 1 year ]
    EORTC QLQ-C30 + FA13

  8. Intermediate toxicity - quality of life [ Time Frame: up to 1 year ]

  9. Intermediate toxicity - lymphoedema/ shoulder dysfunction [ Time Frame: up to 1 year ]
    EORTC BR23

  10. Organ at risk dose - ipsilateral lung [ Time Frame: Immediate ]
    mean dose to the ipsilateral lung (Gy) measured using DVH

  11. Organ at risk dose - contralateral lung [ Time Frame: Immediate ]
    mean dose to the contralateral lung (Gy) measured using DVH

  12. Organ at risk dose - heart [ Time Frame: Immediate ]
    mean dose to the heart (Gy) measured using DVH

  13. Organ at risk dose - contralateral breast [ Time Frame: Immediate ]
    mean dose to the contralateral breast (Gy) measured using DVH

  14. Organ at risk dose - thyroid [ Time Frame: Immediate ]
    mean dose to the thyroid (Gy) measured using DVH

  15. Organ at risk dose - humeral head [ Time Frame: Immediate ]
    mean dose to the humeral head (Gy) measured using DVH

  16. Organ at risk dose - brachial plexus [ Time Frame: Immediate ]
    maximum dose to the brachial plexus (Gy) measured using DVH

  17. Organ at risk dose - Left anterior descending coronary artery [ Time Frame: Immediate ]
    maximum dose to the Left anterior descending coronary artery (Gy) measured using DVH

  18. Organ at risk dose - oesophagus [ Time Frame: Immediate ]
    maximum dose to the oesophagus (Gy) measured using DVH

  19. Time taken to plan and check radiotherapy [ Time Frame: Immediate ]
  20. Inter-fraction reproducibility [ Time Frame: 3 weeks ]
    Distance - shift from planning CT on CBCT (mm)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥18 years
  • Female or male
  • Invasive carcinoma of the breast (left or right-sided)
  • Breast conservation surgery or mastectomy
  • Axillary staging and/or dissection
  • pT1-T4,N1-2,M0 disease
  • Histological involvement of axillary lymph nodes
  • Indication for radiotherapy to the IMC, axillary levels I-III and/or level IV
  • Patient able to tolerate breath hold
  • Performance status 0-1

Exclusion Criteria:

  • Contralateral and/or previous ipsilateral breast cancer, irrespective of date of diagnosis
  • Past medical history of malignancy except (i) basal cell skin carcinoma, (ii) CIN cervix uteri, (iii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
  • Previous radiotherapy to any region above the diaphragm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02771353

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Contact: Alison Ranger, MBBS BSc 02083613169
Contact: Anna Kirby, BA(Hons), MB Chir 02083613169

Sponsors and Collaborators
Royal Marsden NHS Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust Identifier: NCT02771353     History of Changes
Other Study ID Numbers: CCR4501
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases