Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer

Phase 1

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06080061
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-12
• Study Start: 2023-10-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-12
• Last Update Posted: 2025-07-15
• Primary Completion: 2026-11
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Dose limiting pulmonary and esophageal toxicity	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.

Secondary Outcome Measures

Name	Time	Method
Acute and Late Toxicities	36 months	Patients will be evaluated by the rates of acute and late grade 2+ toxicities including lung, esophageal, cardiac, chest wall, and neurologic.
Local control	36 months	Determine local control in patients treated with hypofractionated radiation therapy with concurrent systemic therapy
Integrated adaptive dosing regimen with an automated planning system	36 months	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.
Overall survival	36 months	Determine overall survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy
Progression free survival	36 months	Determine progression free survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States