Small-cell Lung CancerNCT04342429
Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
A study testing Proton-beam Therapy for Small Cell Lung Cancer in people with Small-cell Lung Cancer, run by Emory University at 1 site in United States.
Trial summary
To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- Proton-beam Therapy for Small Cell Lung Cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2020to 27 May 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pathologically confirmed small cell lung cancer, limited or extensive stage.
- Patients who are offered thoracic radiotherapy with intensity-modulated proton therapy (IMPT) techniques delivering 30-66 Gy in 15-33 fractions at 2 Gy per fraction, at the recommendation of the treating radiation oncologist.
- Age 18 or greater
Who cannot join
- Prior radiation therapy which would provide significant dose overlap with the planned target volume(s)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Winship Cancer Institute
Atlanta, Georgia, 30322
Kristin Higgins, MD, 404-778-0603, kristin.higgins@emory.edu
Allyson Anderson, 404-251-2854, allyson.anderson@emory.edu
About this study
Official title: RAD4649-19: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)
Read the detailed description
To determine the optimal schedule for three-dimensional verification imaging and necessary re-planning of patients undergoing IMPT for a rapidly changing tumor (small cell lung cancer).
- To determine the rate of cardiac toxicities from IMPT in patients with small cell lung cancer compared with historical controls receiving photon-based treatment.
- To determine the rate of pneumonitis and esophagitis from IMPT and compare with historical controls receiving photon based treatment.
- Conditions
- Small-cell Lung Cancer
- Being tested
- Proton-beam Therapy for Small Cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton-beam Therapy for Small Cell Lung CancerRadiation
The goal of intensity-modulated proton therapy (IMPT) is to deliver radiation to the tumor while minimizing exposure to surrounding normal tissues.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Study of Intensity-Modulated Proton Therapy (IMPT) | Experimental | This is the first prospective study to investigate the safety and efficacy of IMPT for the treatment of SCLC. We will utilize adaptive planning throughout the radiation course. In addition, we will study the dosimetric parameters of IMPT and their correlation with treatment-related toxicities, particularly cardiac events. Receives: Radiation: Proton-beam Therapy for Small Cell Lung Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT).
Patients enrolled will experience <35% incidence of cardiac events at 1-year. Cardiac events included are acute heart disease, acute myocardial infarction, cardiomyopathy, dysrhythmia, heart failure, pericarditis, and pericardial effusion.
Measured: Up to 1 year from study start
Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning
The optimal frequency of conebeam CT during treatment will be determined by a mixed model:
- The local control, distant metastases, patterns of failure will be summarized as frequency and percentage.
- Chi-square test will be used to test their relationships with other categorical variables.
- General linear model will be used to measure their association with continuous covariates with and without adjusting for other factors
Measured: Up to 1,2, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start19 Mar 2020
- Primary completion27 May 2027 (estimated)
- Study completion27 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Emory 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibo Tian, Emory University
- Investigators
- Kristin Higgins, MD, Principal investigator, Emory University-Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342429
- Sponsor's protocol ID
- IRB00110109
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAD4649-19: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04342429
- Acronym / sponsor ID
- IRB00110109
- Conditions
- Small-cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 27 May 2027 (estimated)
- Study completion
- 27 May 2028 (estimated)
- First posted
- 13 Apr 2020 (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.
To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)
Detailed description
To determine the optimal schedule for three-dimensional verification imaging and necessary re-planning of patients undergoing IMPT for a rapidly changing tumor (small cell lung cancer).
- To determine the rate of cardiac toxicities from IMPT in patients with small cell lung cancer compared with historical controls receiving photon-based treatment.
- To determine the rate of pneumonitis and esophagitis from IMPT and compare with historical controls receiving photon based treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Study of Intensity-Modulated Proton Therapy (IMPT) | Experimental | Radiation: Proton-beam Therapy for Small Cell Lung CancerThis is the first prospective study to investigate the safety and efficacy of IMPT for the treatment of SCLC. We will utilize adaptive planning throughout the radiation course. In addition, we will study the dosimetric parameters of IMPT and their correlation with treatment-related toxicities, particularly cardiac events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pathologically confirmed small cell lung cancer, limited or extensive stage.
- Patients who are offered thoracic radiotherapy with intensity-modulated proton therapy (IMPT) techniques delivering 30-66 Gy in 15-33 fractions at 2 Gy per fraction, at the recommendation of the treating radiation oncologist.
- Age 18 or greater
Key exclusion criteria (2 listed)
- Prior radiation therapy which would provide significant dose overlap with the planned target volume(s)
- Pregnancy
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 |
|---|---|---|
| Proton-beam Therapy for Small Cell Lung CancerThe goal of intensity-modulated proton therapy (IMPT) is to deliver radiation to the tumor while minimizing exposure to surrounding normal tissues. | Radiation | Prospective Study of Intensity-Modulated Proton Therapy (IMPT) |
Primary outcome
Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT).
Time frame: Up to 1 year from study start
Patients enrolled will experience <35% incidence of cardiac events at 1-year. Cardiac events included are acute heart disease, acute myocardial infarction, cardiomyopathy, dysrhythmia, heart failure, pericarditis, and pericardial effusion.
Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning
Time frame: Up to 1,2, and 5 years
The optimal frequency of conebeam CT during treatment will be determined by a mixed model: * The local control, distant metastases, patterns of failure will be summarized as frequency and percentage. * Chi-square test will be used to test their relationships with other categorical variables. * General linear model will be used to measure their association with continuous covariates with and without adjusting for other factors
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 17 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Kristin Higgins, MD principal investigator
Emory University-Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton-beam Therapy for Small Cell Lung Cancer in people with Small-cell Lung Cancer, run by Emory University at 1 site 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 3 inclusion and 2 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Kristin Higgins, MD (404-778-0603, kristin.higgins@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT). (time frame: Up to 1 year from study start). The study lists 2 primary outcomes in all. 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 17 Sep 2026.