NCT03256981

Stereotactic Body Radiotherapy for the Treatment of OPD

Targeted Therapy With or Without Dose Intensified Radiotherapy for Oligo-progressive Disease in Oncogene-addicted Lung Tumours

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Institute of Cancer Research, United Kingdom · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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 oligoprogressive disease (OPD) following initial response to a Tyrosine Kinase Inhibitor (TKI).

Detailed description

Eligible patients will be randomised to receive either SBRT or no SBRT at a ratio of 2:1 (SBRT : no SBRT), with all patients continuing to receive background treatment with TKI therapy as clinically indicated and as per standard care. Patients randomised to receive SBRT will receive a dose and fractionation schedule dependent on OPD lesion site and proximity to critical normal tissues. All patients will be seen 8 weeks post randomisation, then 3 monthly in line with routine care. HALT aims to assess whether in patients with mutation positive advanced NSCLC the use of SBRT to ≤ 3 sites of OPD with continuation of TKI improves progression-free survival (PFS) compared with continuation of TKI alone.

Conditions

• NSCLC

Interventions

Type	Name	Description
RADIATION	SBRT	SBRT dose and fractionation dependent on site of metastasis and proximity to critical normal tissues.
DRUG	TKI	Continued background TKI alone

Timeline

• Start date: 2017-11-27
• Primary completion: 2023-07-17
• Completion: 2025-06-30
• First posted: 2017-08-22
• Last updated: 2023-12-26

Locations

29 sites across 5 countries: France, Italy, Spain, Switzerland, United Kingdom