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NCT Number: NCT06080061

Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University, Palo Alto, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionated accelerated radiation therapy

Radiation

Hypofractionated accelerated radiation therapy

Primary outcomes

  1. Dose limiting pulmonary and esophageal toxicity

    Time frame: 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 outcomes

  1. Acute and Late Toxicities

    Time frame: 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

    Time frame: 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

    Time frame: 36 months

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

  4. Overall survival

    Time frame: 36 months

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

  5. Local control

    Time frame: 36 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Aastha Dubey

CONTACT

adubey7@[email protected]

650-725-2084

Sonya Boyd

CONTACT

[email protected]

650-723-2732

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • LUNGevity Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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