Pilot study of Neoadjuvant Stereotactic Radiosurgery for Breast Cancer and Non-small Cell Lung Cancer Intracranial Metastases NEST Trial (NEoadjuvant STereotactic)

Not Applicable

• Conditions: brain metastases; breast cancer; non-small cell lung cancer; Cancer - Breast; Cancer - Lung - Non small cell

• Registration Number: ACTRN12621000951853
• Lead Sponsor: St Vincent's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-21
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to evaluate the feasibility of neoadjuvant stereotactic radiosurgery (SRS) for intracranial metastases in metastatic breast cancers<br>This will be assessed by evaluating the number of patients recruited to the trial compared to the number of patients that undertake the treatment[6mths post intervention];to evaluate the feasibility of neoadjuvant stereotactic radiosurgery (SRS) for intracranial metastases in metastatic non-small cell lung cancers<br>This will be assessed by evaluating the number of patients recruited to the trial compared to the number of patients that undertake the treatment[6 mths post intervention]

Secondary Outcome Measures

Name	Time	Method
ocal recurrence rates of resected tumour as assessed on follow up MRI images<br><br>[6mths and 12 mths post intervention];Rates of leptomeningeal disease as assessed on follow up MRI images[6 and 12mths post intervention];Progression free survival as assessed on MRI imaging +/- clinical signs or symptoms[6 and 12mths post intervention];Patient satisfaction assessed on study specific patient satisfaction questionnaire [6 and 12 mths post intervention];Rates of necrosis assessed on follow up MRI imaging[6 and 12mths post intervention];Resource utilisation as per study specific resource allocation tool[6 and 12 mths post intervention]