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Spots Global Cancer Trial Database for Local Consolidative Radiotherapy for Oligoprogressive in Non-small Cell Lung Carcinoma

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Trial Identification

Brief Title: Local Consolidative Radiotherapy for Oligoprogressive in Non-small Cell Lung Carcinoma

Official Title: A Randomized Phase II Study of Local Consolidative Radiotherapy Versus Standard of Care Second Line Systemic Therapy in Patients With Oligoprogressive NSCLC on Immune Checkpoint Inhibitors

Study ID: NCT04485026

Study Description

Brief Summary: This is a randomized phase II study designed to evaluate the effect of local consolidative radiation therapy (LCT) to all sites of oligoprogressive disease in patients with metastatic non-small cell lung carcinoma who have progressed through first line systemic therapy containing an immune checkpoint inhibitor (ICI).

Detailed 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 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Michael Farris, MD

Affiliation: Wake Forest University Health Sciences

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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