HALT - Stereotactic Body Radiotherapy for the treatment of OPD
Research type
Research Study
Full title
Targeted therapy with or without dose intensified radiotherapy for oligo-progressive disease in oncogene-addicted lung tumours
IRAS ID
219505
Contact name
Fiona McDonald
Contact email
Sponsor organisation
The Institute of Cancer Research
Duration of Study in the UK
4 years, 6 months, 3 days
Research summary
Treatment of patients with advanced non-small cell lung cancer (NSCLC) and EGFR (epidermal growth factor) mutations or ALK (anaplastic lymphoma kinase) rearrangements has developed significantly with tyrosine kinase inhibitor (TKI) therapies. Higher response rates and progression free survival (PFS) are seen compared to comparator chemotherapy; however disease progression will ultimately occur in all patients due to acquired resistance to TKI.
A proportion of patients progress initially at a limited number of sites (≤ 3), termed oligo progressive disease (OPD). Optimal management of these patients is uncertain and further systemic options are limited in the UK. Stereotactic body radiotherapy (SBRT) delivers high dose radiation to small, well-defined tumour targets whilst limiting doses received to surrounding tissue. The benefit of SBRT treatment prior to change in systemic treatment is an important question to be addressed. HALT aims to assess whether SBRT treatment to OPD sites increases time patients benefit from TKI therapy until further disease progression.
HALT is a phase II, randomised multi-centre study with integrated seamless continuation to phase III trial following acceptable safety and feasibility assessment. HALT aims to recruit 110 patients with mutation positive advanced NSCLC with OPD following initial response to TKI. Patients will continue on background TKI and will be randomisation (2:1) to receive SBRT or not. Patients will be seen 8 weeks post randomisation, then 3 monthly in line with routine care. Tumour imaging and toxicity assessment will be 3 monthly until disease progression. Quality of Life will be assessed at baseline, 8 weeks and at the first 3 month visit. Research bloods will be collected a baseline, after the first SBRT fraction (treatment group), 8 weeks and 3 monthly until change in systemic therapy. PFS defined as time from randomisation to ‘poly’-progression (>3 progressing lesions) or death will be the primary endpoint.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/0980
Date of REC Opinion
28 Jun 2017
REC opinion
Favourable Opinion