Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorRutgers, The State University of New Jersey
About this trial
Primary Objective:
Evaluate the role of ctDNA positivity in decision making for postoperative therapy for non-small cell lung cancer. The plan for postoperative therapy will be declared after pathology report review and before the ctDNA result. We will assess if ctDNA result changed the planned therapy.
Secondary Objectives:
Evaluate personalized postoperative Chemo/ICPI/Targeted Therapies/Radiation Therapy in clearing ctDNA Evaluate the disease-free survival (DFS) and overall survival (OS) of stage II/III lung cancer patients with postoperative ctDNA positive status
Exploratory Objective:
Evaluate radiomics features based on serial CT thoracic CT scans to determine if radiomic features can be associated with ctDNA positivity/negativity.
Eligibility criteria
Qualifiers
Have provided signed informed consent for the trial
Aged ≥18 years at the time of informed consent
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Diagnosed with histologically confirmed Stage II-III NSCLC and undergone surgical resection of lung tumor
Disqualifiers
Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent
With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician.
Have known active CNS metastases and/or carcinomatous meningitis.
Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.
Trial design
Treatments tested in this trial
- Haystack™ ctDNA Assay
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov