Local Consolidative Radiotherapy for Oligoprogressive in Non-small Cell Lung Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Non -Small Cell Lung Cancer
- Oligoprogressive
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary Objective: To compare overall survival (OS) from the time of the time of randomization between the treatment and control groups. Secondary Objective(s) To compare the extra-CNS PFS2 (EC-PFS2), defined as the time to extracranial disease progression on second line systemic therapy or death fr...
Primary Objective: To compare overall survival (OS) from the time of the time of randomization between the treatment and control groups. Secondary Objective(s) To compare the extra-CNS PFS2 (EC-PFS2), defined as the time to extracranial disease progression on second line systemic therapy or death from the first day of local consolidative radiation therapy (treatment group) or from the start of second line therapy (control group). To evaluate time to initiation of second line systemic therapy or palliative care after completion of local consolidative therapy in the treatment group To compare the toxicities in the treatment and control groups; To compare overall progression free survival from the time of the first day of local consolidative radiation therapy for the treatment group and from the start of second line therapy for the control group To compare the pattern of next progression on second line therapy in the treatment group vs the control group. To evaluate local progression in lesions treated with local consolidative radiation therapy.
Tracking Information
- NCT #
- NCT04485026
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Michael Farris, MD Wake Forest University Health Sciences