Breast CancerPhase 2NCT02771353
The HeartSpare Plus 1B Trial
A Phase 2 study testing WT_vDIBH and VMAT_FB in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- WT_vDIBH and VMAT_FB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2016to 15 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- WT_vDIBH, VMAT_FB
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WT_vDIBHRadiation
VMAT_FBRadiation
| Study group | Role | What they receive |
|---|---|---|
| WT_vDIBH | Active comparator | Wide tangent radiotherapy in voluntary deep inspiratory breath hold Receives: Radiation: WT_vDIBH |
| VMAT_FB | Active comparator | Volumetric modulated arc therapy in free breathing. Receives: Radiation: VMAT_FB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear Accelerator time
Patient mounting couch to linear accelerator being turned off
Measured: 3 weeks
Secondary outcomes (20)
Acute toxicity - Skin
CTCAE grading
Measured: 5 weeks
Acute toxicity - lung (pneumonitis)
CTCAE grading
Measured: 5 weeks
Acute toxicity - oesophagitis
CTCAE grading
Measured: 5 weeks
Acute toxicity - fatigue
EORTC QLQ-C30 + FA13
Measured: 5 weeks
Acute toxicity - quality of life
EORTC QLQ-C30 + BR23
Measured: 5 weeks
Intermediate toxicity - lung (pneumonitis)
CTCAE pneumonitis assesment
Measured: up to 1 year
Intermediate toxicity - fatigue
EORTC QLQ-C30 + FA13
Measured: up to 1 year
Intermediate toxicity - quality of life
EORTC QLQ-C30
Measured: up to 1 year
Intermediate toxicity - lymphoedema/ shoulder dysfunction
EORTC BR23
Measured: up to 1 year
Organ at risk dose - ipsilateral lung
mean dose to the ipsilateral lung (Gy) measured using DVH
Measured: Immediate
Organ at risk dose - contralateral lung
mean dose to the contralateral lung (Gy) measured using DVH
Measured: Immediate
Organ at risk dose - heart
mean dose to the heart (Gy) measured using DVH
Measured: Immediate
Organ at risk dose - contralateral breast
mean dose to the contralateral breast (Gy) measured using DVH
Measured: Immediate
Organ at risk dose - thyroid
mean dose to the thyroid (Gy) measured using DVH
Measured: Immediate
Organ at risk dose - humeral head
mean dose to the humeral head (Gy) measured using DVH
Measured: Immediate
Organ at risk dose - brachial plexus
maximum dose to the brachial plexus (Gy) measured using DVH
Measured: Immediate
Organ at risk dose - Left anterior descending coronary artery
maximum dose to the Left anterior descending coronary artery (Gy) measured using DVH
Measured: Immediate
Organ at risk dose - oesophagus
maximum dose to the oesophagus (Gy) measured using DVH
Measured: Immediate
Time taken to plan and check radiotherapy
Measured: Immediate
Inter-fraction reproducibility
Distance - shift from planning CT on CBCT (mm)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start12 Dec 2016
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771353
- Sponsor's protocol ID
- CCR4501
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2016
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02771353
- Acronym / sponsor ID
- CCR4501
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WT_vDIBH | Active comparator | Radiation: WT_vDIBHWide tangent radiotherapy in voluntary deep inspiratory breath hold |
| VMAT_FB | Active comparator | Radiation: VMAT_FBVolumetric modulated arc therapy in free breathing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WT_vDIBH | Radiation | WT_vDIBH |
| VMAT_FB | Radiation | VMAT_FB |
Primary outcome
Linear Accelerator time
Time frame: 3 weeks
Patient mounting couch to linear accelerator being turned off
20 secondary outcomes
Acute toxicity - Skin
Time frame: 5 weeks
Acute toxicity - lung (pneumonitis)
Time frame: 5 weeks
Acute toxicity - oesophagitis
Time frame: 5 weeks
Acute toxicity - fatigue
Time frame: 5 weeks
Acute toxicity - quality of life
Time frame: 5 weeks
Intermediate toxicity - lung (pneumonitis)
Time frame: up to 1 year
Intermediate toxicity - fatigue
Time frame: up to 1 year
Intermediate toxicity - quality of life
Time frame: up to 1 year
Intermediate toxicity - lymphoedema/ shoulder dysfunction
Time frame: up to 1 year
Organ at risk dose - ipsilateral lung
Time frame: Immediate
Organ at risk dose - contralateral lung
Time frame: Immediate
Organ at risk dose - heart
Time frame: Immediate
Organ at risk dose - contralateral breast
Time frame: Immediate
Organ at risk dose - thyroid
Time frame: Immediate
Organ at risk dose - humeral head
Time frame: Immediate
Organ at risk dose - brachial plexus
Time frame: Immediate
Organ at risk dose - Left anterior descending coronary artery
Time frame: Immediate
Organ at risk dose - oesophagus
Time frame: Immediate
Time taken to plan and check radiotherapy
Time frame: Immediate
Inter-fraction reproducibility
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WT_vDIBH and VMAT_FB in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear Accelerator time (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.