Phase I Trial of Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer

Stanford University1 site in 1 country45 target enrollmentOctober 25, 2023

ConditionsLung Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: Stanford University
Enrollment: 45
Locations: 1
Primary Endpoint: Dose limiting pulmonary and esophageal toxicity
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 25, 2023

End Date

December 1, 2026

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically documented malignancy of the lung including 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
•Age \> 18 years old
•Ability to understand and the willingness to personally sign the written IRB approved informed consent document
•Estimated life expectancy of 12 weeks or longer

Exclusion Criteria

•Contraindication to receiving radiotherapy or systemic therapy as determined by treating radiation and medical oncologist
•Age \< 18 years old
•Tumor directly invading the major pulmonary arteries, aorta, heart or proximal bronchial tree
•Diagnosis of interstitial pulmonary fibrosis
•Previous radiation therapy to the thorax that would result in overlapping high dose radiation fields

Outcomes

Primary Outcomes

Dose limiting pulmonary and esophageal toxicity

Time Frame: 9 months

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.