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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03256981
Other study ID # ICR-CTSU/2016/10061
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date November 27, 2017
Est. completion date June 30, 2025

Study information

Verified date December 2023
Source Institute of Cancer Research, United Kingdom
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 113
Est. completion date June 30, 2025
Est. primary completion date July 17, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: 1. Male or female, = 16 years of age 2. Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with defined actionable mutation receiving targeted TKI therapy 3. Clinical and/or radiologically confirmed response to TKI therapy (assessed locally usually 2-3 months post commencing TKI) 4. Confirmed OPD defined as = 5 extracranial sites of progressive disease. All sites must be visible, imaging defined targets and suitable for treatment with SBRT as determined by the virtual multi-disciplinary team (MDT) and in accordance with the HALT Radiotherapy planning and delivery guidance document. 5. Adequate baseline organ function to allow SBRT to all relevant targets 6. Predicted life expectancy = 6 months 7. Karnofsky Index = 60% and ECOG 0-2 8. Provision of written informed consent Exclusion Criteria: 1. > 5 extracranial sites of progressive disease 2. Progressing or newly diagnosed brain metastases identified at the time of trial entry, not amenable to radical surgery or SRS. Previously treated brain metastases (i.e palliative radiotherapy or systemic therapy) which have remained clinically and radiologically stable for = 6 months are permissible. 3. Prior radiotherapy near the oligoprogressive lesion precluding ablative SBRT. Suitability of lesions for ablative SBRT as part of the trial defined in section 4.1 of this document and will be determined by the HALT virtual MDT 4. Co-morbidities considered clinically precluding the safe use of SBRT (as detailed in the HALT radiotherapy planning and delivery guidelines). 5. Any psychological, sociological or geographical issue potentially hampering compliance with the study 6. Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
SBRT
SBRT dose and fractionation dependent on site of metastasis and proximity to critical normal tissues.
Drug:
TKI
Continued background TKI alone

Locations

Country Name City State
France Institut Gustave Roussy Paris
France Institut Claudius Régaud Toulouse
Italy Policlinico Universitario Campus Bio-Medico Roma
Italy Ospedale San Luigi Gonzaga - Universita Di Torino Torino
Spain Hospital Clinic Universitari de Barcelona Barcelona
Spain Institut Català d'Oncologia Barcelona
Spain University Hospital Virgen del Rocio Seville
Switzerland Oncology Institute of Southern Switzerland Bellinzona
Switzerland Hopital Cantonal Universitaire De Geneve Geneva
Switzerland Kantonsspital St. Gallen St. Gallen
Switzerland UniversitatsSpital Zurich Zurich
United Kingdom Belfast City Hospital Belfast
United Kingdom Bristol Haematology and Oncology Centre Bristol
United Kingdom Royal Marsden Hospital Chelsea London
United Kingdom Western General Hospital Edinburgh
United Kingdom Beatson West of Scotland Cancer Centre Glasgow
United Kingdom Royal Surrey County Hospital Guildford Surrey
United Kingdom Castle Hill Hospital Hull
United Kingdom Leicester Royal Infirmary Leicester
United Kingdom Guy's Hospital London
United Kingdom St Bartholomew's Hospital London
United Kingdom University College London Hospital London
United Kingdom The Christie Hospital Manchester
United Kingdom Nottingham City Hospital Nottingham
United Kingdom Churchill Hospital Oxford
United Kingdom Weston Park Hospital Sheffield
United Kingdom Southampton University Hospital Southampton
United Kingdom Royal Marsden Hosital Sutton England
United Kingdom Clatterbridge Cancer Centre Wirral

Sponsors (1)

Lead Sponsor Collaborator
Institute of Cancer Research, United Kingdom

Countries where clinical trial is conducted

France,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival The primary outcome measure is progression free survival defined as the time from randomisation to the first of one of the following events or death from any cause:
Clinically symptomatic progression requiring palliative tumour-specific oncological intervention (e.g. change in systemic therapy or localised non-SBRT radiotherapy) as determined by the treating physician.
New or existing intra-cranial lesions not amenable to radical surgery or Stereotactic radiosurgery (SRS).
Development of new extra-cranial lesions or progression of existing extra-cranial lesions not meeting the criteria for
SBRT treatment (e.g. size >7cm)
Development of >5 new or progressing extra-cranial lesion at any one point in time (i.e. widespread progression)
Time from randomisation to the first of one of the above events or death. Assessed 8 weeks post-randomisation and 3-monthly thereafter (up to 24 months)
Secondary Time to next line of systemic therapy or palliative care Time from randomisation to change in therapy or referral to palliative care due to clinical progression as determined by the treating physician, or death. Assessed 3-monthly until progression and 6-monthly thereafter (up to 24 months).
Secondary Overall survival Time from randomisation until death from any cause. Assessed up to 24 months.
Secondary Patterns of disease progression identified from CT scans to further document natural history of oncogene-addicted NSCLC Assessed 3-monthly up to 24 months.
Secondary Radiotherapy toxicities (acute events) Acute events are defined as = 90 days post SBRT start date (applicable for each subsequent course of SBRT where relevant) assessed using CTCAE v4.0. Baseline, 8 weeks and 3-monthly intervals during follow-up (a minimum of 6 months).
Secondary Radiotherapy toxicities (late events) Late events are defined as > 90 days post SBRT start date (applicable for each subsequent course of SBRT where relevant) assessed using CTCAE v4.0. Baseline, 8 weeks and 3-monthly intervals during follow-up (a minimum of 6 months).
Secondary Quality of Life (EQ-5D-5L) Assessed using EQ-5D-5L Baseline, 8 weeks and at the first 3 month visit.
Secondary Quality of Life (EORTC QLQ-C30) Assessed using EORTC QLQ-C30 Baseline, 8 weeks and at the first 3 month visit.
Secondary Measurement of resistant sub-clones in Circulating tumour DNA (ctDNA) Baseline, 8 weeks post-randomisation and 3-monthly intervals during follow-up (up to 24 months).
Secondary Time to failure of next line treatment Time from randomisation to disease progression on next line of active systemic therapy. Assessed up to 24 months.
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