An Evaluation of Dose-escalation for Intrathoracic Tumours
ConditionLung Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChris Goodman
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hypofractionated Radiation Therapy
RadiationHypofractionated, dose-escalated, esophageal-sparing intensity modulated radiation therapy
Radiation Therapy
Radiationstandard of care palliative thoracic radiotherapy using volumetric modulated arc therapy/intensity-modulating radiotherapy
Treatment groups
141 Participants
are divided into 2 treatment groupsGroup A: Standard RadiotherapyActive comparator 1 intervention
Group B: Experimental RadiotherapyExperimental treatment 1 intervention
Trial outcomes
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
Time frame
from enrollment until 36 months post radiotherapySecondary outcomes
1
Quality of Life - Patient Reported Outcomes
Measured via Functional Assessment of Cancer Therapy: Lung and EuroQol 5-dimension 5-level
Time frame
From enrollment until 36 months post radiotherapy2
Toxicity - Adverse Events that happen to a patient during the clinical trial
Defined as incidence of Common Terminology Criteria for Adverse Events version 5 grade 2 and higher toxicity
Time frame
From enrollment until 36 months post radiotherapy3
Freedom from intrathoracic progression
Defined as time from randomization to disease progression within the thorax, or last follow-up, whichever occurs first
Time frame
From enrollment until 36 months post radiotherapy4
Overall Survival
Defined as time from randomization to death from any cause, or last follow-up, whichever occurs first
Time frame
From enrollment until 36 months post radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Chris Goodman
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor institution
Source ClinicalTrials.gov