Stereotactic Body Radiotherapy for the Treatment of OPD (HALT)

December 19, 2023 updated by: Institute of Cancer Research, United Kingdom

Targeted Therapy With or Without Dose Intensified Radiotherapy for Oligo-progressive Disease in Oncogene-addicted Lung Tumours

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Paris, France, 94800
        • Institut Gustave Roussy
      • Toulouse, France, 31059
        • Institut Claudius Regaud
  • Italy
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico
      • Torino, Italy, 10043
        • Ospedale San Luigi Gonzaga - Universita Di Torino
  • Spain
      • Barcelona, Spain, 08908
        • Institut Catala d'Oncologia
      • Barcelona, Spain, 08036
        • Hospital Clinic Universitari de Barcelona
      • Seville, Spain, 41013
        • University Hospital Virgen del Rocio
  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Oncology Institute of Southern Switzerland
      • Geneva, Switzerland
        • Hôpital Cantonal Universitaire de Genève
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen
      • Zurich, Switzerland, 8091
        • UniversitätsSpital Zürich
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Hull, United Kingdom, HU16 5JQ
        • Castle Hill Hospital
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, SE1 9RT
        • Guy'S Hospital
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • London, United Kingdom, NW1 2PG
        • University College London Hospital
      • Manchester, United Kingdom, M20 4BX
        • The Christie Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Oxford, United Kingdom, OX3 7LE
        • Churchill Hospital
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton University Hospital
      • Wirral, United Kingdom, CH63 4JY
        • Clatterbridge Cancer Centre
    • England
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden Hosital
    • London
      • Chelsea, London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Continued TKI therapy alone
Continuation on the same background TKI treatment as prior to trial entry
Drug: TKI
Continued background TKI alone
Other Names:
  • Tyrosine Kinase Inhibitor
Experimental: 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.
Radiation: SBRT
SBRT dose and fractionation dependent on site of metastasis and proximity to critical normal tissues.
Other Names:
  • SABR
  • Stereotactic body radiotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 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)

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to next line of systemic therapy or palliative care
Time Frame: 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).
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).
Overall survival
Time Frame: Time from randomisation until death from any cause. Assessed up to 24 months.
Time from randomisation until death from any cause. Assessed up to 24 months.
Patterns of disease progression identified from CT scans to further document natural history of oncogene-addicted NSCLC
Time Frame: Assessed 3-monthly up to 24 months.
Assessed 3-monthly up to 24 months.
Radiotherapy toxicities (acute events)
Time Frame: Baseline, 8 weeks and 3-monthly intervals during follow-up (a minimum of 6 months).
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).
Quality of Life (EQ-5D-5L)
Time Frame: Baseline, 8 weeks and at the first 3 month visit.
Assessed using EQ-5D-5L
Baseline, 8 weeks and at the first 3 month visit.
Quality of Life (EORTC QLQ-C30)
Time Frame: Baseline, 8 weeks and at the first 3 month visit.
Assessed using EORTC QLQ-C30
Baseline, 8 weeks and at the first 3 month visit.
Measurement of resistant sub-clones in Circulating tumour DNA (ctDNA)
Time Frame: Baseline, 8 weeks post-randomisation and 3-monthly intervals during follow-up (up to 24 months).
Baseline, 8 weeks post-randomisation and 3-monthly intervals during follow-up (up to 24 months).
Time to failure of next line treatment
Time Frame: Time from randomisation to disease progression on next line of active systemic therapy. Assessed up to 24 months.
Time from randomisation to disease progression on next line of active systemic therapy. Assessed up to 24 months.
Radiotherapy toxicities (late events)
Time Frame: Baseline, 8 weeks and 3-monthly intervals during follow-up (a minimum of 6 months).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Cancer Research, United Kingdom

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fiona McDonald, MD, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICR-CTSU/2016/10061

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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