Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
NRG Oncology
PRIMARY OBJECTIVE: I. In patients with NSCLC who develop locoregional disease recurrence after thoracic radiotherapy, to compare progression-free survival outcomes following curative-intent reirradiation versus systemic therapy alone. SECONDARY OBJECTIVES: I. To compare overall survival outcomes across study arms. II. To compare clinician-scored adverse events, scored using Common Terminology Criteria for Adverse Events (CTCAE), across study arms. III. To compare patient-reported adverse events, scored using Patient-Reported Outcomes (PRO)-CTCAE, across study arms. IV. To compare patterns of disease progression across study arms. EXPLORATORY OBJECTIVES: I. To evaluate clinical and dosimetric predictors of high-grade treatment-related toxicity within the experimental study arm. II. To compare the toxicity and efficacy of proton beam radiotherapy versus photon radiotherapy within the experimental study arm. III. To calculate regional lung ventilation using four-dimensional (4D) computed tomography (CT) planning scans and evaluate associated predictors of pulmonary toxicity. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive standard of care (SOC) systemic therapy, which may include chemotherapy, immunotherapy, and/or targeted therapy on study. Patients also undergo positron emission tomography/computed tomography (PET/CT) and magnetic resonance imaging (MRI) during screening, as well as chest CT and optional blood sample collection throughout the study. ARM 2: Patients undergo radiation therapy (RT) for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study. After completion of study treatment, patients are followed up periodically until 5 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
