Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Oncology Institute of Southern Switzerland
Coordinator of this site? Confirm its status
BellinzonaSwitzerlandUnknown status
Hopital Cantonal Universitaire de Geneve
Coordinator of this site? Confirm its status
GenevaSwitzerlandUnknown status
Kantonsspital St. Gallen
Coordinator of this site? Confirm its status
Sankt GallenSwitzerlandUnknown status
Universitätsspital Zürich
Coordinator of this site? Confirm its status
ZurichSwitzerlandUnknown status
Institut Catala d'Oncologia
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hospital Clinic Universitari de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
University Hospital Virgen del Rocio
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Institut Gustave Roussy
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Institut Claudius Regaud
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
Belfast City Hospital
Coordinator of this site? Confirm its status
BelfastUnited KingdomUnknown status
Bristol Haematology and Oncology Centre
Coordinator of this site? Confirm its status
BristolUnited KingdomUnknown status
Royal Marsden Hospital
Coordinator of this site? Confirm its status
ChelseaUnited KingdomUnknown status
Western General Hospital
Coordinator of this site? Confirm its status
EdinburghUnited KingdomUnknown status
Beatson West of Scotland Cancer Centre
Coordinator of this site? Confirm its status
GlasgowUnited KingdomUnknown status
Royal Surrey County Hospital
Coordinator of this site? Confirm its status
GuildfordUnited KingdomUnknown status
Castle Hill Hospital
Coordinator of this site? Confirm its status
HullUnited KingdomUnknown status
Leicester Royal Infirmary
Coordinator of this site? Confirm its status
LeicesterUnited KingdomUnknown status
St. Bartholomew's Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Guy's Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
University College London Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
The Christie Hospital
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Clatterbridge Cancer Centre
Coordinator of this site? Confirm its status
Metropolitan Borough of WirralUnited KingdomUnknown status
Nottingham City Hospital
Coordinator of this site? Confirm its status
NottinghamUnited KingdomUnknown status
Churchill Hospital
Coordinator of this site? Confirm its status
OxfordUnited KingdomUnknown status
Weston Park Hospital
Coordinator of this site? Confirm its status
SheffieldUnited KingdomUnknown status
Southampton University Hospital
Coordinator of this site? Confirm its status
SouthamptonUnited KingdomUnknown status
Royal Marsden Hosital,
Coordinator of this site? Confirm its status
SuttonUnited KingdomUnknown status
Policlinico Universitario Campus Bio-Medico
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Ospedale San Luigi Gonzaga - Universita Di Torino
Coordinator of this site? Confirm its status
TorinoItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.