Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer

NCT ID: NCT06080061

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2026-12-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypofractionated accelerated radiation therapy (HART)

Patients 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

Group Type: EXPERIMENTAL

Hypofractionated accelerated radiation therapy

Intervention Type: RADIATION

Hypofractionated accelerated radiation therapy

Interventions

Hypofractionated accelerated radiation therapy

Hypofractionated accelerated radiation therapy

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LUNGevity Foundation

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucas K Vitzthum, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alyssa Yauger

Role: CONTACT

ayauger@stanford.edu

650-498-5271

Mimi Le-Budka

Role: CONTACT

mlebudka@stanford.edu

650-498-1933

Facility Contacts

Alyssa Yauger

Role: primary

ayauger@stanford.edu

650-498-5271

Other Identifiers

NCI-2024-00696

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB-71744

Identifier Type: -

Identifier Source: org_study_id