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NCT Number: NCT06794125

An Evaluation of Dose-escalation for Intrathoracic Tumours

This is a pragmatic trial with patients randomized between standard of care palliative thoracic radiation therapy (RT) vs. hypofractionated, dose-escalated, esophageal-sparing (HD-ES) intensity modulated radiation therapy (IMRT).

The investigators hypothesize that the use of advanced radiation planning techniques to optimize dose to esophagus will permit the safe delivery of a modestly dose-escalated five-fraction course of palliative radiation to intrathoracic malignancies. This approach aims to deliver higher biologically effective doses while improving toxicity when compared to conventional approaches with the goal of prolonging high-quality overall survival.

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Key information

Conditions

Lung Cancers Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Cancer Agency Center for the Southern Interior, Kelowna, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intrathoracic tumour requiring palliative radiation, either for palliation of symptoms or prevention of progression that is expected to cause symptoms in the next 6 months (in the judgement of the enrolling investigator)
  • Willingness and ability to provide informed consent
  • Eastern Cooperative Oncology Group performance status 0-3
  • Age 18 years or older
  • Prior or planned systemic treatment (chemotherapy, immunotherapy, targeted agents) is permissible at the discretion of the treating medical oncologist
  • Concurrent palliative radiotherapy to other metastatic sites is permissible at the discretion of the treating radiation oncologist.
  • Life expectancy greater than 3 months

Exclusion criteria

  • Prior thoracic radiotherapy which, in the opinion of the treating of radiation oncologist, precludes the delivery of further thoracic radiotherapy. If there has been prior thoracic radiotherapy, a composite of all RT plans must be created, and the dose constraints herein must still be met. An allowance for 10 percent repair is permitted if at least 12 months have passed between the prior radiotherapy and the trial protocol specified radiotherapy.
  • Serious medical comorbidities which, in the opinion of the treating radiation oncologist, preclude the delivery of radiotherapy. This includes interstitial lung disease.
  • Pregnant or lactating women
  • Inability to attend the full course of radiotherapy or planned follow-up visits

Treatment and study plan

Hypofractionated Radiation Therapy

Radiation

Hypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy

radiation therapy

Radiation

standard of care palliative thoracic radiotherapy using volumetric modulated arc therapy/intensity-modulating radiotherapy

Primary outcomes

  1. time to definitive quality of life deterioration or death

    Time frame: from enrollment until 36 months post radiotherapy

    Defined as time from randomization to the first of:

    i. deterioration in Functional Assessment of Cancer Therapy: Lung Trial Outcome Index score by greater than or equal to 5 points compared to baseline score and with no subsequent improvement to within 5 points of baseline ii. death iii. last follow-up

Secondary outcomes

  1. Quality of Life - Patient Reported Outcomes

    Time frame: From enrollment until 36 months post radiotherapy

    Measured via Functional Assessment of Cancer Therapy: Lung and EuroQol 5-dimension 5-level

  2. Toxicity - Adverse Events that happen to a patient during the clinical trial

    Time frame: From enrollment until 36 months post radiotherapy

    Defined as incidence of Common Terminology Criteria for Adverse Events version 5 grade 2 and higher toxicity

  3. Freedom from intrathoracic progression

    Time frame: From enrollment until 36 months post radiotherapy

    Defined as time from randomization to disease progression within the thorax, or last follow-up, whichever occurs first

  4. Overall Survival

    Time frame: From enrollment until 36 months post radiotherapy

    Defined as time from randomization to death from any cause, or last follow-up, whichever occurs first

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Goodman, MD

CONTACT

[email protected]

519-685-8650

David Palma, MD

CONTACT

[email protected]

519-685-8650

Sponsors and collaborators

Lead sponsor

Chris Goodman

Other

Registry information

Official study title

A Phase II/III Randomized Evaluation of Dose-escalation With Esophageal-sparing for Palliation of Intrathoracic Tumours (PREVENT)

Acronym: PREVENT-LUNG

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 27, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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