An Evaluation of Dose-escalation for Intrathoracic Tumours

NCT06794125 | Recruiting DMC

• 1 other identifier: PREVENT-LUNG
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Lung Cancers

Keywords

lung cancer; radiation therapy; hypofractionated; esophageal-sparing; dose-escalated; intrathoracic

Outcome Measures

Primary Outcomes (1)

• time to definitive quality of life deterioration or death

  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

  from enrollment until 36 months post radiotherapy

Secondary Outcomes (4)

• Quality of Life - Patient Reported Outcomes

  From enrollment until 36 months post radiotherapy

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

  From enrollment until 36 months post radiotherapy

• Freedom from intrathoracic progression

  From enrollment until 36 months post radiotherapy

• Overall Survival

  From enrollment until 36 months post radiotherapy

Study Arms (2)

Standard Radiotherapy

ACTIVE COMPARATOR

20 Gray in 5 fractions or 30 Gray in 10 fractions.

Radiation: Radiation Therapy

Experimental Radiotherapy

EXPERIMENTAL

35 Gray in 5 fractions

Radiation: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation Therapy RADIATION

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

Experimental Radiotherapy

Radiation Therapy RADIATION

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

Standard Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chris Goodman: lead

Study Sites (3)

British Columbia Cancer Agency Center for the Southern Interior

Kelowna, British Columbia, V1Y5L3, Canada

RECRUITING

London Health Sciences Center Research Institute (Formerly Lawson Research Institute)

London, Ontario, N6A 4L6, Canada

RECRUITING

Waterloo Regional Health Network

Waterloo, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Christopher Goodman, MD

CONTACT

519-685-8650; Chris.Goodman@lhsc.on.ca

David Palma, MD

CONTACT

519-685-8650; David.Palma@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)