Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080061
• Other study ID #: IRB-71744
• Status: Recruiting
• Phase: Phase 1
• Start date: October 25, 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Jillian Skerchak
• Phone: 650-721-4072
• Email: jskerch1[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• Hypofractionated accelerated radiation therapy
Hypofractionated accelerated radiation therapy

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	LUNGevity Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	36 months
Secondary	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.	36 months
Secondary	Progression free survival	Determine progression free survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy	36 months
Secondary	Overall survival	Determine overall survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy	36 months
Secondary	Local control	Determine local control in patients treated with hypofractionated radiation therapy with concurrent systemic therapy	36 months