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| Name | Class |
|---|---|
| University of Leicester | OTHER |
| Centro Nacional de Investigaciones Oncologicas CARLOS III | OTHER |
| East and North Hertfordshire NHS Trust | OTHER_GOV |
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The aim of this study is to demonstrate if it is possible to delivering a novel and modern radiotherapy approach (Dose Escalated internal PTV (DE-iPTV)) and to collect health related quality of life in patients whose breast cancer has spread to the brain (brain metastases) at 8 weeks post enrolling into the study.
The main questions that have been set out to to answer are:
Participants will:
Brain metastases from breast cancer are a common, and devastating, complication with survival times of 3 - 5 months from diagnosis.
The main treatment approaches to brain metastases are surgery, stereotactic radiosurgery (SRS), and whole brain radiotherapy. However, it is known that most patients with brain metastases receive either whole-brain radiotherapy (WBRT) or no treatment, with relatively low rates of surgery and SRS. Since the commonest treatment in those who do have treatment is WBRT, the local team have developed an approach that is believed to be (possibly) more effective than WBRT. The objective is to evaluate this approach in patients who are not suitable to receive more aggressive treatment and who would otherwise receive WBRT. The local approach involves using a modern radiotherapy planning approach, combined with careful, intra-metastasis dose escalation (Dose Escalated internal PTV (DE-iPTV)) to deliver a higher dose to tumour, while delivering less dose to the brain. The combination of less dose to normal structures and more dose to the lesion will hopefully improve Health-related Quality of Life (HRQoL).
The aim of this study is to demonstrate the feasibility of delivering complex radiotherapy, dose escalated internal PTV (DE-iPTV), and measuring quality of life at 8 weeks post-enrolment for patients with brain metastases from breast cancer who would otherwise receive WBRT. An exploratory blood-based biomarker sample collection and analysis will be completed. Furthermore, linked national cancer data will be used to measure the number of patients currently offered WBRT, including survival costs and hospital admissions, and thus provide a baseline to estimate the impact of this novel approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-iPTV radiotherapy | Experimental | Patients will undergo a radiotherapy planning scan, and an upto date MRI brain with contrast. Patients will receive 5 fractions of DE-iPTV radiotherapy over 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-iPTV | Radiation | Dose-escalated VMAT-based radiotherapy, as previously described in our planning study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of delivering DE-iPTV and measuring health related quality of life questionnaire in patients with brain metastases from breast cancer to whom their treating clinician would normally offer whole brain radiotherapy | Completion of radiotherapy and completion of EuroQol- 5 Dimension (EQ-5D-5L) questionnaire | 8 weeks post-enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Lesional Response | Lesional response and intracranial progression measured using RANO-BM criteria | 8 weeks |
| Intracranial progression | Intracranial progression based on RANO-BM |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood-based biomarkers | Change between baseline and week 8 levels of Circulating Tumour DNA (ctDNA) and S100 | 8 weeks |
| Imaging Changes | MRI-based response (as per RANO-BM and serial volumetric measurements) |
Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lillie Pakzad-Shahabi, BSc MSc | Contact | 02033118427 | beat-breast@imperial.ac.uk | |
| Matt Williams, FRCR PhD | Contact | 02033118427 | matthew.williams@imperial.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | SW7 2AZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35182688 | Background | Chen J, Sinclair G, Rozati H, Hill L, Pakzad-Shahabi L, Wang J, Calvez KL, Paddick I, Williams M. Improving on whole-brain radiotherapy in patients with large brain metastases: A planning study to support the AROMA clinical trial. Radiother Oncol. 2022 May;170:176-183. doi: 10.1016/j.radonc.2022.02.011. Epub 2022 Feb 17. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Norfolk and Norwich University Hospitals NHS Foundation Trust |
| OTHER |
| Imperial College Healthcare NHS Trust | OTHER |
Non-randomised interventional multi-centre feasibility trial in patients with brain metastases from breast cancer receiving dose escalated internal PTV (DE-iPTV) radiotherapy
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| 3 months |
| Intracranial progression | Intracranial progression based on RANO-BM | 6 months |
| Treatments | Use of further brain-directed therapies (reported by clinician) | Within 6 months of enrolment |
| Central Nervous System (CNS) Failures | Time to CNS failure (either lesional progression or developing a new lesion as per RANO-BM) | Within 6 months of enrolment |
| Neurological toxicities | Acute and late neurological/ CNS toxicity as assessed using CTCAE v5 | Within 6 months of enrolment |
| Health Related Quality of Life | HRQoL over time (participants reported outcomes for descriptive analysis) | Within 6 months of enrolment |
| Time to deterioration in quality of life | Time to deterioration in Health Related Quality of Life - measured as time to first time there is a minimum clinically significant change in EuroQol- 5 Dimension (EQ-5D-5L) | Within 6 months of enrolment |
| Symptom Burden | Symptom burden assessed by collection of clinician-recorded toxicities | Within 6 months of enrolment |
| Steroid usage | Use of corticosteroids over time, assessed through clinician reports and patient diaries | Within 6 months of enrolment |
| Quality-Adjusted Life Year | Quality-Adjusted Life Year | Within 6 months of enrolment |
| Overall survival | Overall survival | End of study |
| Up to 6 months post enrolment |
| Radiation Necrosis | Radiation necrosis based on radiologist report | Up to 6 months post enrolment |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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