Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
This clinical trial tests proton beam radiation therapy in patients with non-small cell lung cancer who have undergone surgical resection and have lymph nodes involving the middle of the chest. Proton therapy is a type of radiation treatment that kills cancer cells while avoiding surrounding healthy tissue. Proton beam therapy is sometimes used after cancer surgery to reduce the risk of cancer recurrence (coming back). Giving proton beam radiation therapy may work better than conventional radiation treatment after surgery in patients with non-small cell lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%)
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Proton Beam Radiation Therapy
RadiationUndergo proton beam radiation therapy
Radiology, Treatment Planning
Other interventionUndergo radiation treatment planning
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Treatment (proton beam radiation therapy)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Incidence of adverse events (AEs)
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.
Time frame
Up to 90 days from enrollmentSecondary outcomes
1
Radiation dose to immune compartment
Time frame
Single episode prior to first radiation treatment2
Disease-free survival
Examine the association of dose with disease-free survival. Cox proportional hazard model along with Kalan-Meier method will be applied.
Time frame
From date of surgery to the date of local, regional, or distant recurrence or death, whichever earlier, with censoring at the date of the last follow up, assessed up to 24 months after first dose of radiation3
Overall survival
Examine the association of dose with overall survival. Cox proportional hazard model along with Kaplan-Meier method will be applied.
Time frame
From the date of surgery to the date of death with censoring at date of last follow up if alive, assessed up to 24 months after first dose of radiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov