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
Qualifiers
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
Treatments tested in this trial
- Biospecimen Collection
- Proton Beam Radiation Therapy
- Radiology, Treatment Planning
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov