Lung CancerNCT06080061
Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer
A study testing Hypofractionated accelerated radiation therapy in people with Lung Cancer, run by Stanford University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Hypofractionated accelerated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Oct 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented malignancy of the thorax including but not limited to 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
- PET/CT or CT Imaging of Thorax
- 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
Who cannot join
- Contraindication to receiving radiotherapy or systemic therapy as determined by treating radiation and medical oncologist
- Age < 18 years old
- Diagnosis of interstitial pulmonary fibrosis
- Previous radiation therapy to the thorax that would result in overlapping high dose radiation fields
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94305
Aastha Dubey, 650-725-2084, adubey7@stanford.edu
Sonya Boyd, 650-723-2732, boydso@stanford.edu
- Recruiting
Stanford Cancer Center South Bay
San Jose, California, 95124
Aastha Dubey, 650-725-2084, adubey7@stanford.edu
Sonya Boyd, 650-723-2732, boydso@stanford.edu
About this study
Official title: Phase I Trial of 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.
- Conditions
- Lung Cancer
- Being tested
- Hypofractionated accelerated radiation therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated accelerated radiation therapyRadiation
Hypofractionated accelerated radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated accelerated radiation therapy (HART) | Experimental | 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 Receives: Radiation: Hypofractionated accelerated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (5)
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.
Measured: 36 months
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.
Measured: 36 months
Progression free survival
Determine progression free survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy
Measured: 36 months
Overall survival
Determine overall survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy
Measured: 36 months
Local control
Determine local control in patients treated with hypofractionated radiation therapy with concurrent systemic therapy
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start25 Oct 2023
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- LUNGevity Foundation
- Responsible party
- Sponsor
- Investigators
- Joseph A Jaoude, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080061
- Sponsor's protocol ID
- IRB-71744
- Other IDs
- NCI-2024-00696
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer
- ClinicalTrials.gov ID
- NCT06080061
- Acronym / sponsor ID
- IRB-71744
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- LUNGevity Foundation
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated accelerated radiation therapy (HART) | Experimental | Radiation: Hypofractionated accelerated radiation therapyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically documented malignancy of the thorax including but not limited to 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
- PET/CT or CT Imaging of Thorax
- Age ≥ 18 years old
- Ability to understand and the willingness to personally sign the written IRB approved informed consent document
Key exclusion criteria (4 listed)
- Contraindication to receiving radiotherapy or systemic therapy as determined by treating radiation and medical oncologist
- Age < 18 years old
- Diagnosis of interstitial pulmonary fibrosis
- Previous radiation therapy to the thorax that would result in overlapping high dose radiation fields
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated accelerated radiation therapyHypofractionated accelerated radiation therapy | Radiation | Hypofractionated accelerated radiation therapy (HART) |
Primary outcome
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.
5 secondary outcomes
Acute and Late Toxicities
Time frame: 36 months
Integrated adaptive dosing regimen with an automated planning system
Time frame: 36 months
Progression free survival
Time frame: 36 months
Overall survival
Time frame: 36 months
Local control
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph A Jaoude, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated accelerated radiation therapy in people with Lung Cancer, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aastha Dubey (650-725-2084, adubey7@stanford@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting pulmonary and esophageal toxicity (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.