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Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06080061
Collaborator
LUNGevity Foundation (Other)
45
Enrollment
1
Location
1
Arm
37
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Hypofractionated accelerated radiation therapy
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Trial of Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer
Anticipated Study Start Date :
Oct 31, 2023
Anticipated Primary Completion Date :
Nov 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Radiation: Hypofractionated accelerated radiation therapy
Hypofractionated accelerated radiation therapy

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. Progression free survival [36 months]

    Determine progression free survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy

  4. Overall survival [36 months]

    Determine overall survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy

  5. Local control [36 months]

    Determine local control in patients treated with hypofractionated radiation therapy with concurrent systemic therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Palo Alto California United States 94305

Sponsors and Collaborators

  • Stanford University
  • LUNGevity Foundation

Investigators

  • Principal Investigator: Lucas K Vitzthum, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT06080061
Other Study ID Numbers:
  • IRB-71744
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 13, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms

Study Results

No Results Posted as of Oct 13, 2023