Status:
UNKNOWN
Stereotactic Body Radiotherapy for the Treatment of OPD
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Conditions:
NSCLC
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief 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 wi...
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 i...
Eligibility Criteria
Inclusion
- 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
Exclusion
- \> 5 extracranial sites of progressive disease
- 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).
- Any psychological, sociological or geographical issue potentially hampering compliance with the study
- Pregnancy
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT03256981
Start Date
November 27 2017
End Date
June 30 2025
Last Update
December 26 2023
Active Locations (29)
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1
Institut Gustave Roussy
Paris, France, 94800
2
Institut Claudius Régaud
Toulouse, France, 31059
3
Policlinico Universitario Campus Bio-Medico
Roma, Italy, 00128
4
Ospedale San Luigi Gonzaga - Universita Di Torino
Torino, Italy, 10043