Proton Beam Radiation Therapy for Non-Small Cell Lung Cancer After Surgery
This study is testing proton beam radiation therapy in people with non-small cell lung cancer that has been surgically removed, especially if cancer cells were found in the lymph nodes (glands that are part of your immune system) in the middle of the chest. Proton beam radiation therapy is a type of radiation that aims to kill cancer cells while protecting healthy tissues nearby. The main goal is to see how safe proton beam radiation therapy is. Researchers will also look at how well it works and collect blood samples. You may be able to join if you are 18 or older and have had surgery to completely remove your non-small cell lung cancer.
- Study design
- This is an interventional study with an unclear phase, planning to enroll 20 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would undergo radiation treatment planning, receive proton beam radiation therapy, and have blood samples collected. You will be followed for 24 months after your first radiation treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed up for 24 months after the first dose of radiotherapy.
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NCT06008730
Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentEmory UniversityInvestigator-initiated
~20 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Biospecimen CollectionProton Beam Radiation TherapyRadiology, Treatment Planning
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Up to 90 days from enrollment
Conditions
Where it's being run
1 sites across 1 statesGeorgia1
Study leadership
- William Stokes · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age \>= 18 years
Patients must have undergone complete surgical resection after pre-operative systemic therapy. Complete resections are defined as BOTH lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy AND lymph node dissection with at least three mediastinal (N2) stations sampled
Pathology report from surgical resection indicating complete resection of primary tumor (R0 resection) AND tumor involvement of at least one mediastinal lymph node (pN2) AND no tumor involvement of highest dissected mediastinal lymph node. Patients who have initially positive margins that are secondarily cleared on additional margins will be eligible
Eastern Cooperative Oncology Group Performance (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
Life expectancy \> 12 weeks as determined by the investigator
Hemoglobin \>= 9.0 g/dl (no transfusions allowed within 7 days of simulation to meet entry criteria) (within 28 days of cycle 1 day 1)
White blood cell \>= 2000/uL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1)
Platelets \>= 100,000/mcL (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) (within 28 days of cycle 1 day 1)
Serum creatinine =\< 2 mg/dL (or glomerular filtration rate \>= 40 mL/min) (within 28 days of cycle 1 day 1)
Because radiotherapy is known to be teratogenic, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of radiotherapy. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
Completion of all previous therapy (including surgery, chemotherapy, or investigational therapy) for the treatment of cancer \>= 2 weeks before the start of radiotherapy
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
Exclusion
Patients who have stage IV disease
Patients who have had systemic therapy less than 2 weeks prior to anticipated radiotherapy start
Patients who have received prior thoracic radiotherapy
Patients who have a prior history of NSCLC (other than index diagnosis)
Patients who have small cell lung cancer
Patients whose tumors exhibit targetable alterations in EGFR or ALK
Patients with incomplete surgical resection, including R1 (microscopic residual disease) or R2 resection (macroscopic residual disease), sampling of fewer than three mediastinal lymph node stations, unremoved positive lymph nodes, malignant pleural effusion, or malignant pericardial effusion
Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled grade \>= 3 hypertension (diastolic blood pressure \>= 100 mmHg or systolic blood pressure \>= 160 mmHg) despite antihypertensive therapy
The following vulnerable populations will not be offered participation in this study:
Adults with cognitive impairment or unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
What this trial measures
- Incidence of adverse events (AEs)Up to 90 days from enrollment
AEs will be categorized according to Common Terminology Criteria for Adverse Events (CTCAE) and classified as either early (occurring any time from enrollment through 90 days) or late (occurring any time from 90 days through 2 years). Will also categorize toxicity according to grade and separately report toxicity of any grade and toxicity of high grade (grade 3 or greater). Descriptive statistics will be used to summarize the data.