ETOP 19-21 USZ-STRIKE Protocol Version 1.0
Research type
Research Study
Full title
A multicentre randomised open-label phase III study of stereotactic radiosurgery, in addition to standard systemic therapy for patients with metastatic melanoma or newly diagnosed metastatic NSCLC and asymptomatic or oligo-symptomatic brain metastases.
IRAS ID
318680
Contact name
Mary O'Brien
Contact email
Sponsor organisation
ETOP IBCSG Partners Foundation
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The USZ-STRIKE Study
Patients with brain metastases represent a group who can have many symptoms and a poor prognosis due to drugs not penetration well into the brain. Radiotherapy is a localised treatment, but whole brain radiotherapy (WBRT) has been both toxic and has not extended life (the UK Quartz trial).
Modern day radiotherapy with high dose treatment to only the brain metastases (sparing non affected areas of the brain) appears both active and well tolerated.
More modern day drugs are also looking more hopeful for activity in the brain, particularly the family of tyrosine kinase inhibitors (TKI) for those patients with an EGF or ALK mutation. Immunotherapy is also a new treatment and has also shown activity in the brain. Some chemotherapy agents e.g platinum compounds, pemetrexed and paclitaxel have good brain penetration.
Should brain metastases be treated with radiation immediately after diagnosis to minimise the further growth of the brain metastases? Or should radiation therapy only be initiated after drug therapies have proven to be ineffective in treating the brain metastases? To date, there is no clear answer to this question.
The randomised clinical trial ETOP 19-21 USZ-STRIKE seeks to find an answer to this question.
The patients who participate in this study have been newly diagnosed with brain metastases deriving from melanoma or from a type of lung cancer known as “non-small cell lung cancer”. The brain metastases must not have been previously treated.
One group of the patients in the USZ-STRIKE study will receive radiation therapy to the brain at about the same time they start drug therapy for their cancer. The other group of patients receive only drug therapy to treat their cancer. In case their brain metastases have grown again, these patients may receive radiation therapy to the brain at a later time point.
Between these two groups, the trial will compare the time until the brain metastases grow again.
The trial also aims to investigate how radiation therapy affects the mental functions (for example, attention, memory and speech), the activities of daily living (for example, dressing, and personal hygiene) and the overall quality of life.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
24/LO/0222
Date of REC Opinion
21 Mar 2024
REC opinion
Favourable Opinion