Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000951853
Ethics application status
Approved
Date submitted
7/08/2020
Date registered
21/07/2021
Date last updated
21/07/2021
Date data sharing statement initially provided
21/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of Neoadjuvant Stereotactic Radiosurgery for Breast Cancer and Non-small Cell Lung Cancer Intracranial Metastases
NEST Trial (NEoadjuvant STereotactic)
Scientific title
Pilot Study of Fesability of Neoadjuvant Radiosurgery for Breast Cancer and Non-Small Cell Lung Cancer Intracranial Metastases
Secondary ID [1] 300940 0
Nil known
Universal Trial Number (UTN)
U1111-1252-1906
Trial acronym
NEST Trial (NEoadjuvant STereotactic)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
brain metastases 316940 0
breast cancer 319018 0
non-small cell lung cancer 319019 0
Condition category
Condition code
Cancer 315102 315102 0 0
Breast
Cancer 316974 316974 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the feasibility of performing stereotactic radiosurgery prior to operative management to remove brain lesions in patients with metastatic breast or non-small cell lung cancer.

Participants enrolled in this study will attend a radiotherapy planning appointment where they will undergo a brain CT scan and a MRI brain, these scans should occur within 2 weeks of the radiotherapy treatment and must be performed at the treating centre. At the time of the CT scan a stereotactic radiotherapy mask will be made for immobilisation during radiotherapy treatment. A single radiation treatment will take place after an appropriate treatment plan has been formulated. The dose will depend of the size of the lesion (<2.5cm diameter=16Gy, 2.5-3cm diameter=14Gy and 3.1-4cm diameter=12Gy). This treatment is likely to take less than 2 hours. Within 48 hours of the stereotactic radiotherapy a neurosurgeon will then operate to remove the cancer tissue from the brain. Surgical intervention is not anticipated to take any longer as a result of the neo-adjuvant radiotherapy.

Participants will then be asked to attend follow-up visits with their doctor and have regular follow up MRI scans, as normal, and information regarding their disease progress after the procedure will be shared with the research team. Participants will also be asked to complete a short study questionnaire about their satisfaction with the radiosurgery intervention at 6 and 12 months after the procedures were completed.
Intervention code [1] 317254 0
Treatment: Other
Intervention code [2] 318260 0
Treatment: Surgery
Intervention code [3] 318566 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323836 0
to evaluate the feasibility of neoadjuvant stereotactic radiosurgery (SRS) for intracranial metastases in metastatic breast cancers
This will be assessed by evaluating the number of patients recruited to the trial compared to the number of patients that undertake the treatment
Timepoint [1] 323836 0
6mths post intervention
Primary outcome [2] 324661 0
to evaluate the feasibility of neoadjuvant stereotactic radiosurgery (SRS) for intracranial metastases in metastatic non-small cell lung cancers
This will be assessed by evaluating the number of patients recruited to the trial compared to the number of patients that undertake the treatment
Timepoint [2] 324661 0
6 mths post intervention
Secondary outcome [1] 383019 0
Local recurrence rates of resected tumour as assessed on follow up MRI images
Timepoint [1] 383019 0
6mths and 12 mths post intervention
Secondary outcome [2] 385353 0
Rates of leptomeningeal disease as assessed on follow up MRI images
Timepoint [2] 385353 0
6 and 12mths post intervention
Secondary outcome [3] 385354 0
Progression free survival as assessed on MRI imaging +/- clinical signs or symptoms
Timepoint [3] 385354 0
6 and 12mths post intervention
Secondary outcome [4] 385355 0
Patient satisfaction assessed on study specific patient satisfaction questionnaire
Timepoint [4] 385355 0
6 and 12 mths post intervention
Secondary outcome [5] 385356 0
Rates of necrosis assessed on follow up MRI imaging
Timepoint [5] 385356 0
6 and 12mths post intervention
Secondary outcome [6] 385357 0
Resource utilisation as per study specific resource allocation tool
Timepoint [6] 385357 0
6 and 12 mths post intervention

Eligibility
Key inclusion criteria
• Histologically confirmed metastatic breast cancer and non-small cell lung cancer
• New intra-cranial metastases requiring surgical resection for reduction of symptoms or mass effect
• MRI evidence of 1-4 brain metastases
• >/= 18 years age
• Not pregnant or breast feeding
• No other cancer diagnosis for >5years excluding non-melanomatous skin cancer
• Willingness to give written informed consent and willingness to participate in and comply with the study.
• ECOG performance status 0-2
• Deemed appropriate for surgical management by Neurosurgeon
• Combined size of all lesions < /=30cm3
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-breast or NSCLC histopathology
• Metastases >4cm max diameter
• Number of metastases >5
• Previous whole brain radiotherapy
• Patients unfit for surgery
• Patients who have had bevacizumab systemic therapy within the last 6 weeks
• Any contra-indications to anaesthetic
• Any contra-indications to MRI

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will be by intention to treat principle as far as is practically possible. Results will be presented throughout using 95% confidence intervals and a 5% level of statistical significance. Time to event outcomes will be analysed using Kaplan Meier curves, log rank tests and Cox Proportional Hazards models. Assumptions of proportional hazards will be investigated. Ordinal categorical outcomes will be analysed using an ordinal logistic model. Continuous outcomes will be assessed using ANCOVA methods

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/08/2021
Actual
Date of last participant enrolment
Anticipated
31/03/2022
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16696 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 16697 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 30295 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 30296 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 305383 0
Commercial sector/Industry
Name [1] 305383 0
GenesisCare
Country [1] 305383 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria St Darlinghurst, NSW, 2010
Country
Australia
Secondary sponsor category [1] 305760 0
None
Name [1] 305760 0
Address [1] 305760 0
Country [1] 305760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305714 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 305714 0
390 Victoria St Darlinghurst NSW 2010
Ethics committee country [1] 305714 0
Australia
Date submitted for ethics approval [1] 305714 0
04/11/2019
Approval date [1] 305714 0
20/12/2019
Ethics approval number [1] 305714 0
2019/ETH12233

Summary
Brief summary
This study will investigate the feasibility of performing stereotactic radiosurgery prior to operative management to remove brain lesions in patients with metastatic breast or non-small cell lung cancer.

Who is it for?
You may be eligible for this study if you are aged 18 or older and have confirmed metastatic breast cancer or non-small cell lung cancer with between 1-4 identified brain lesions that require surgical removal.

Study details
Participants enrolled in this study will attend a radiotherapy planning appointment where they will undergo a brain CT scan and a MRI brain. At the time of the CT scan a stereotactic radiotherapy mask will be made for immobilisation during radiotherapy treatment. Radiation treatment will take place after an appropriate treatment plan has been formulated. Within 48 hours of the stereotactic radiotherapy a neurosurgeon will then operate to remove the cancer tissue from the brain. Participants will then be asked to attend follow-up visits with their doctor and have regular follow up MRI scans, as normal, and information regarding their disease progress after the procedure will be shared with the research team. Participants will also be asked to complete a short study questionnaire about their satisfaction with the radiosurgery intervention at 6 and 12 months after the procedures were completed.

It is hoped this research will demonstrate that the combination of radiotherapy prior to surgical intervention for the treatment of brain lesions is feasible, and that a larger trial to investigate the efficacy of these treatments for cancer patients can be conducted in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101322 0
Dr Cecelia Gzell
Address 101322 0
GenesisCare St Vincent's Hospital
Level A/438 Victoria St, Darlinghurst NSW 2010
Country 101322 0
Australia
Phone 101322 0
+61 0413691047
Fax 101322 0
Email 101322 0
cecelia.gzell@genesiscare.com
Contact person for public queries
Name 101323 0
Dr Cecelia Gzell
Address 101323 0
GenesisCare St Vincent's Hospital
Level A/438 Victoria St, Darlinghurst NSW 2010
Country 101323 0
Australia
Phone 101323 0
+61 0413691047
Fax 101323 0
Email 101323 0
cecelia.gzell@genesiscare.com
Contact person for scientific queries
Name 101324 0
Dr Cecelia Gzell
Address 101324 0
GenesisCare St Vincent's Hospital
Level A/438 Victoria St, Darlinghurst NSW 2010
Country 101324 0
Australia
Phone 101324 0
+61 0413691047
Fax 101324 0
Email 101324 0
cecelia.gzell@genesiscare.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No publication policy has yet been implemented for this study


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.