The HeartSpare Plus 1B Trial

Breast Cancer Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771353
• Other study ID #: CCR4501
• Status: Completed
• Phase: Phase 2
• Start date: December 12, 2016
• Est. completion date: January 15, 2019

Study information

• Verified date: April 2022
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• WT_vDIBH

• VMAT_FB

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linear Accelerator time	Patient mounting couch to linear accelerator being turned off	3 weeks
Secondary	Acute toxicity - Skin	CTCAE grading	5 weeks
Secondary	Acute toxicity - lung (pneumonitis)	CTCAE grading	5 weeks
Secondary	Acute toxicity - oesophagitis	CTCAE grading	5 weeks
Secondary	Acute toxicity - fatigue	EORTC QLQ-C30 + FA13	5 weeks
Secondary	Acute toxicity - quality of life	EORTC QLQ-C30 + BR23	5 weeks
Secondary	Intermediate toxicity - lung (pneumonitis)	CTCAE pneumonitis assesment	up to 1 year
Secondary	Intermediate toxicity - fatigue	EORTC QLQ-C30 + FA13	up to 1 year
Secondary	Intermediate toxicity - quality of life	EORTC QLQ-C30	up to 1 year
Secondary	Intermediate toxicity - lymphoedema/ shoulder dysfunction	EORTC BR23	up to 1 year
Secondary	Organ at risk dose - ipsilateral lung	mean dose to the ipsilateral lung (Gy) measured using DVH	Immediate
Secondary	Organ at risk dose - contralateral lung	mean dose to the contralateral lung (Gy) measured using DVH	Immediate
Secondary	Organ at risk dose - heart	mean dose to the heart (Gy) measured using DVH	Immediate
Secondary	Organ at risk dose - contralateral breast	mean dose to the contralateral breast (Gy) measured using DVH	Immediate
Secondary	Organ at risk dose - thyroid	mean dose to the thyroid (Gy) measured using DVH	Immediate
Secondary	Organ at risk dose - humeral head	mean dose to the humeral head (Gy) measured using DVH	Immediate
Secondary	Organ at risk dose - brachial plexus	maximum dose to the brachial plexus (Gy) measured using DVH	Immediate
Secondary	Organ at risk dose - Left anterior descending coronary artery	maximum dose to the Left anterior descending coronary artery (Gy) measured using DVH	Immediate
Secondary	Organ at risk dose - oesophagus	maximum dose to the oesophagus (Gy) measured using DVH	Immediate
Secondary	Time taken to plan and check radiotherapy		Immediate
Secondary	Inter-fraction reproducibility	Distance - shift from planning CT on CBCT (mm)	3 weeks