Platform Overview

Current Candiate Specific Trials (CSTs)

Trial Team

Essential Trial Documentation

Platform Overview

Current Candiate Specific Trials (CSTs)

Trial Team

Essential Trial Documentation

Platform Overview

Current Candiate Specific Trials (CSTs)

Trial Team

Essential Trial Documentation

Platform Overview

Current Candiate Specific Trials (CSTs)

Trial Team

Essential Trial Documentation

Platform Overview

Current Candiate Specific Trials (CSTs)

Trial Team

Essential Trial Documentation

Platform Overview

Current Candiate Specific Trials (CSTs)

Trial Team

Essential Trial Documentation

Platform Overview

Current Candiate Specific Trials (CSTs)

Trial Team

Events

Platform Overview

Current Candiate Specific Trials (CSTs)

Trial Team

Events

Title

Thoracic Umbrella Radiotherapy Study in stage IV NSCLC

Description

TOURIST trial is a Phase III study aimed at evaluating the efficacy of thoracic radiotherapy in treating stage IV non-small cell lung cancer (NSCLC) using advanced radiotherapy techniques. With current palliative thoracic radiotherapy practices based on outdated dose fractionations, the trial seeks to update the evidence base in light of evolving lung cancer management over the past three decades. The trial adopts a pragmatic multi-centre approach, incorporating randomized controlled studies (Candidate-Specific Trials or CSTs) to assess various aspects of thoracic radiotherapy.

Each CST is evaluated separately, allowing for the addition and discontinuation of CSTs as their evaluation completes. The trial's primary objective is to establish the utility of thoracic radiotherapy in stage IV NSCLC, while secondary objectives include assessing patient-reported outcome measures, overall survival, progression-free survival, toxicity, and qualitative outcomes. The trial is expected to involve 36 sites, providing a comprehensive platform for evaluating thoracic radiotherapy in the context of advanced lung cancer management.

Objectives

Different per Candidate Specific Trial but overall:

The overall objective of the TOURIST platform trial is to use advanced radiotherapy techniques to establish the utility of thoracic radiotherapy in the treatment of stage IV NSCLC. All CSTs within the TOURIST platform trial will have a CST-specific list of objectives and endpoints which can be found in the relevant CST protocol. Examples of CST-specific endpoints include Quality of Life (QoL) measures, Patient Reported Outcome Measures (PROMs), toxicity, Overall Survival (OS) and Progression-Free Survival (PFS).

Trial Design

TOURIST is a pragmatic phase III platform that will incorporate a series of Candidate Specific Trials, which will be randomised controlled trials of thoracic radiotherapy in the treatment of stage IV NSCLC.

Each Candidate CST will have its own protocol to be used alongside this Master protocol.

Trial Status

In set-up

Population

Patients with stage IV NSCLC, fit for thoracic radiotherapy without symptoms requiring immediate radiotherapy.

Funder

NIHR logo

PRINCE

Prospective, randomised, multicentre trial of first line systemic treatment and radiotherapy in stage IV non-small cell lung cancer

PRINCE is a multicentre, phase III, parallel group, randomised controlled trial with clinical and cost effectiveness, process evaluation and translational research. Patients will be randomised (1:1) to control or early high-dose palliative radiotherapy; all trial patients will receive first-line systemic therapy. Radiotherapy will be investigator’s choice of 36Gy/12F or 39Gy/13F (CT-planned, 3-D conformal, IMRT, VMAT and Rapid Arc) and will begin within 84 days of randomisation and between cycles 1 and 4 of systemic therapy.

PRIMARY Objective:

To determine the clinical effectiveness of early high-dose palliative thoracic radiotherapy on health utility

SECONDARY Objective:

To determine the clinical effectiveness of early high-dose palliative thoracic radiotherapy on overall survival, progression free survival, quality of life, lung cancer symptoms and acute and late toxicity.

Process and economic evaluation:

To conduct a process evaluation, by interviewing trial patients, patient-carers, and health care professionals to identify the potential implementation barriers, evaluate and explain the treatment and outcomes and highlight issues for PRINCE.
To determine the cost-effectiveness of early high-dose palliative thoracic radiotherapy

QUARTZ LUNG

Quality of life after radiotherapy treatment for patients with stage IV non-small cell Lung cancer

QUARTZ LUNG is a multicentre, Phase III, pragmatic, parallel group, randomised controlled trial with clinical and cost effectiveness, and process evaluation. Patients will be randomised (1:1) to receive symptom-based supportive and palliative care, with or without the addition of early low-dose palliative radiotherapy.

Radiotherapy will be investigators choice of 16-17Gy/2F or 20Gy/5F, (CT-planned, 2D, 3D conformal, IMRT, VMAT) and should commence as soon as possible, but no later than 21 days following randomisation.

Primary Objective and Outcome:

To determine the clinical effectiveness of early low-dose palliative thoracic radiotherapy on health utility.

Secondary Objectives and Outcomes:

To determine the clinical effectiveness of early low-dose palliative thoracic radiotherapy on overall survival, quality of life, lung cancer symptoms, acute and late toxicity.

Process and economic evaluation:

To conduct a process evaluation, by interviewing trial patients, patient-carers, and health care professionals to identify the potential implementation barriers, evaluate and explain the treatment and outcomes and highlight issues for QUARTZ LUNG.
To determine the cost-effectiveness of early low-dose palliative thoracic radiotherapy

Senior Trial Manager:

Nicky Downs

Trial Manager:

Izabela Eberhart, Siva Saranya

Trial Monitor:

Parys Hatchard, Stephanie Hall

Clinical Data Coordinator:

Oliver Edwards