NCT03256981Active, not recruitingPhase 2/3
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
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 113 (actual)
- First submitted
- 10 Aug 2017
- Start date
- 27 Nov 2017
- Primary completion date
- 17 Jul 2023
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Diseases
- Lung cancer, Childhood cancers
- NCT number
- NCT03256981
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 113
- From 27 Nov 2017 to the primary completion date, 17 Jul 2023
- 29 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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
- Co-morbidities considered clinically precluding the safe use of SBRT (as detailed in the HALT radiotherapy planning and delivery guidelines).
Other illness
- \> 5 extracranial sites of progressive disease
Other
- Any psychological, sociological or geographical issue potentially hampering compliance with the study
- Pregnancy
Who the study is looking for
- Male or female, ≥ 16 years of age
- Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with defined actionable mutation receiving targeted TKI therapy
- Clinical and/or radiologically confirmed response to TKI therapy (assessed locally usually 2-3 months post commencing TKI)
- 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.
- Adequate baseline organ function to allow SBRT to all relevant targets
- Predicted life expectancy ≥ 6 months
- Karnofsky Index ≥ 60% and ECOG 0-2
- Provision of written informed consent
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oncology Institute of Southern Switzerland Coordinator of this site? Confirm its status | Bellinzona | Switzerland | Unknown status |
| Hopital Cantonal Universitaire de Geneve Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clinic Universitari de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| University Hospital Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Institut Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Belfast City Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| Bristol Haematology and Oncology Centre Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | Chelsea | United Kingdom | Unknown status |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Beatson West of Scotland Cancer Centre Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Royal Surrey County Hospital Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| Castle Hill Hospital Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Clatterbridge Cancer Centre Coordinator of this site? Confirm its status | Metropolitan Borough of Wirral | United Kingdom | Unknown status |
| Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Churchill Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Weston Park Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Southampton University Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Royal Marsden Hosital, Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Policlinico Universitario Campus Bio-Medico Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale San Luigi Gonzaga - Universita Di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.