Pragmatic Analysis of Complex Radiotherapy Cases In Cancer of the Lung (PRACTICAL)

September 23, 2025 updated by: The Christie NHS Foundation Trust

Pragmatic Analysis of Complex Radiotherapy Cases In Cancer of the Lung (The PRACTICAL Study)

This study focuses on improving care for people with lung cancer who face unusual or complex treatment situations.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

By studying detailed patient data, researchers aim to find the best ways to treat these patients while reducing short- and long-term side effects. The findings will help refine radiotherapy treatments, ensuring they are as safe and effective as possible. Additionally, the results will provide doctors with better information to help patients understand the potential risks and benefits of their treatment options.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

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

Study Locations

  • United Kingdom
    • Greater Manchester
      • Withington, Greater Manchester, United Kingdom, M20 1BX
        • The Christie NHS Foundation Trust

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients over 18 years of age, with stage I, II or III lung cancer undergoing curative-intent radiotherapy at the Christie Hospital.

Description

Inclusion Criteria: Complex patients with lung cancer undergoing radiotherapy in one of the following groups;

  • Rare histology
  • Disease invading vascular structures
  • Co-existing interstitial lung disease (ILD)
  • Radical re-irradiation
  • Oligopersistent/oligoprogressive disease on immunotherapy or targeted therapies.

Exclusion Criteria:

  • Include patients with stage IV disease who are receiving non-curative intent radiotherapy
  • There are no exclusion criteria relating to upper age limit or comorbidities.

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

Cohorts and Interventions

Group / Cohort
Patients with co-existing interstitial lung disease
Patients who undergo radiotherapy twice to the same area (reirradiation).
Patients with the less common or rare types of lung cancer
Patients with cancer invading large blood vessels.
Patients with oligopersistent/oligoprogressive disease on immunotherapy or targeted therapies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute and late toxicity
Time Frame: 2 years
- Acute (<90 days post radiotherapy) and late (> 90 days post radiotherapy) toxicity according to common terminology criteria for adverse events (CTCAE) V5.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported quality of life
Time Frame: 2 years
- Patient reported quality of life (QOL) information from electronic patient reported outcome measure (ePROM) questionnaires.
2 years
Survival
Time Frame: 2 years
- Progression-free survival and overall survival.
2 years

Collaborators and Investigators

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

Sponsor

The Christie NHS Foundation Trust

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)

July 3, 2025

Primary Completion (Estimated)

July 15, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

September 23, 2025

First Posted (Estimated)

October 1, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTSP 230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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