Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer
Phase I Trial of Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer
2 other identifiers
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 lung-cancer
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2023
CompletedFirst Posted
Study publicly available on registry
October 12, 2023
CompletedStudy Start
First participant enrolled
October 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 15, 2025
July 1, 2025
3 years
October 6, 2023
July 12, 2025
Conditions
Outcome Measures
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.
9 months
Secondary Outcomes (5)
Acute and Late Toxicities
36 months
Integrated adaptive dosing regimen with an automated planning system
36 months
Progression free survival
36 months
Overall survival
36 months
Local control
36 months
Study Arms (1)
Hypofractionated accelerated radiation therapy (HART)
EXPERIMENTALPatients will either be treated with 60-66 Gy in 30, 25, or 20 fractions based on ability to meet constraints to key organs at risk
Interventions
Hypofractionated accelerated radiation therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- LUNGevity Foundationcollaborator
Study Sites (1)
Stanford University
Palo Alto, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucas K Vitzthum, MD
Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2023
First Posted
October 12, 2023
Study Start
October 25, 2023
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 15, 2025
Record last verified: 2025-07