Clinical trial NCT02771353: The HeartSpare Plus 1B Trial
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Linear Accelerator time
timeFrame: 3 weeks
Secondary outcomes:
measure: Acute toxicity - Skin
timeFrame: 5 weeks
measure: Acute toxicity - lung (pneumonitis)
timeFrame: 5 weeks
measure: Acute toxicity - oesophagitis
timeFrame: 5 weeks
measure: Acute toxicity - fatigue
timeFrame: 5 weeks
measure: Acute toxicity - quality of life
timeFrame: 5 weeks
measure: Intermediate toxicity - lung (pneumonitis)
timeFrame: up to 1 year
measure: Intermediate toxicity - fatigue
timeFrame: up to 1 year
measure: Intermediate toxicity - quality of life
timeFrame: up to 1 year
measure: Intermediate toxicity - lymphoedema/ shoulder dysfunction
timeFrame: up to 1 year
measure: Organ at risk dose - ipsilateral lung
timeFrame: Immediate
measure: Organ at risk dose - contralateral lung
timeFrame: Immediate
measure: Organ at risk dose - heart
timeFrame: Immediate
measure: Organ at risk dose - contralateral breast
timeFrame: Immediate
measure: Organ at risk dose - thyroid
timeFrame: Immediate
measure: Organ at risk dose - humeral head
timeFrame: Immediate
measure: Organ at risk dose - brachial plexus
timeFrame: Immediate
measure: Organ at risk dose - Left anterior descending coronary artery
timeFrame: Immediate
measure: Organ at risk dose - oesophagus
timeFrame: Immediate
measure: Time taken to plan and check radiotherapy
timeFrame: Immediate
measure: Inter-fraction reproducibility
timeFrame: 3 weeks
Other outcomes:
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