Stereotactic Body Radiotherapy for the Treatment of OPD
NCT ID: NCT03256981
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
113 participants
INTERVENTIONAL
2017-11-27
2025-06-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SBRT and continued TKI therapy
Patients will continue to receive background TKI treatment as prior to trial entry.
Simultaneous administration (SBRT \& TKI) or break in TKI during SBRT will be by centre preference and determined prior to commencing recruitment.
Repeat SBRT will be permissible upon development of subsequent OPD lesions dependent on SBRT suitability and total progression lesion number at any one point remaining ≤ 5.
SBRT
SBRT dose and fractionation dependent on site of metastasis and proximity to critical normal tissues.
Continued TKI therapy alone
Continuation on the same background TKI treatment as prior to trial entry
TKI
Continued background TKI alone
Interventions
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SBRT
SBRT dose and fractionation dependent on site of metastasis and proximity to critical normal tissues.
TKI
Continued background TKI alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
16 Years
ALL
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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Fiona McDonald, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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Institut Gustave Roussy
Paris, , France
Institut Claudius Régaud
Toulouse, , France
Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Ospedale San Luigi Gonzaga - Universita Di Torino
Torino, , Italy
Hospital Clinic Universitari de Barcelona
Barcelona, , Spain
Institut Català d'Oncologia
Barcelona, , Spain
University Hospital Virgen del Rocio
Seville, , Spain
Oncology Institute of Southern Switzerland
Bellinzona, , Switzerland
Hopital Cantonal Universitaire De Geneve
Geneva, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
UniversitatsSpital Zurich
Zurich, , Switzerland
Royal Marsden Hosital
Sutton, England, United Kingdom
Royal Marsden Hospital
Chelsea, London, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Castle Hill Hospital
Hull, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, , 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
Countries
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References
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Lee J, Koom WS, Byun HK, Yang G, Kim MS, Park EJ, Ahn JB, Beom SH, Kim HS, Shin SJ, Kim K, Chang JS. Metastasis-Directed Radiotherapy for Oligoprogressive or Oligopersistent Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2022 Jun;21(2):e78-e86. doi: 10.1016/j.clcc.2021.10.009. Epub 2021 Nov 18.
Other Identifiers
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ICR-CTSU/2016/10061
Identifier Type: -
Identifier Source: org_study_id