Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-086
Prinicipal Investigator
Machtay, Mitchell
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
S1827
Title
S1827 A randomized Phase III trial comparing prophylactic cranial irradiation (PCI) for any patient with small cell lung cancer (either extensive or limited stage) to active surveillance with MRI in place of PCI
Objective
Primary Objective

To evaluate whether overall survival (OS) with MRI surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).

Secondary Objectives

To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms.
To compare brain-metastasis-free survival between the arms.
To compare OS between the arms within the subgroups of patients with limited- stage and extensive-stage disease.
To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms.
To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms.
To compare the frequency and severity of toxicities between the two arms.

Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center