Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
The purpose of this study is to examine the use of hypofractionated accelerated radiation therapy (HART) to treat locally advanced lung cancer. Depending on the location and size of the tumor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically documented malignancy of the thorax including but not limited to non-small cell lung cancer or small cell lung cancer planned for definitive therapy with fractionated radiation (60-66 Gy) and concurrent systemic therapy
ECOG performance status of 0-2
PET/CT or CT Imaging of Thorax
Age ≥ 18 years old
Disqualifiers
Contraindication to receiving radiotherapy or systemic therapy as determined by treating radiation and medical oncologist
Age < 18 years old
Diagnosis of interstitial pulmonary fibrosis
Previous radiation therapy to the thorax that would result in overlapping high dose radiation fields
Trial design
Design model
Single group
Treatments tested in this trial
Hypofractionated accelerated radiation therapy
RadiationHypofractionated accelerated radiation therapy
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Hypofractionated accelerated radiation therapy (HART)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose limiting pulmonary and esophageal toxicity
Toxicities will be scored by the CTCAE v5.0 criteria. Specific toxicities evaluated are grade 2+ pneumonitis and grade 3+ esophagitis as well as other G3+ pulmonary, esophageal or cardiac toxicities that could be probably or definitely attributed to rT.
Time frame
9 monthsSecondary outcomes
1
Acute and Late Toxicities
Patients will be evaluated by the rates of acute and late grade 2+ toxicities including lung, esophageal, cardiac, chest wall, and neurologic.
Time frame
36 months2
Integrated adaptive dosing regimen with an automated planning system
Evaluating the feasibility of integrating an adaptive dosing regimen with an automated planning system with the percentage of automated plans used and the time to plan approval.
Time frame
36 months3
Progression free survival
Determine progression free survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy
Time frame
36 months4
Overall survival
Determine overall survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
LUNGevity Foundation
Collaborator
Source ClinicalTrials.gov