NRG-CC003
Terminated
Protocol Information
Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer
Principal Investigator
Status
Terminated
Open to Accrual
December 7, 2015
Temporarily Closed to Accrual
October 13, 2017
Open to Accrual
January 9, 2019
Temporarily Closed to Accrual
May 28, 2020
Open to Accrual
July 27, 2020
Closed to Accrual
June 21, 2022
Closed to Accrual & Treatment
October 27, 2022
Complete
June 13, 2024
Terminated
September 4, 2025
Disease Site
Symptom Management [CC] Other
Phase
II/III
Developmental Therapeutics
No
Primary Objective
To determine whether the 12-month intracranial relapse rate following HA-PCI is non-inferior compared to the rate following PCI for patients with SCLC
To determine whether HA-PCI reduces the likelihood of 6-month deterioration from baseline in HVLT-R delayed recall compared to the PCI for patients with SCLC
Patient Population
Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration; Zubrod performance status 0-2; Patients who are primary English or French speakers are eligible.
Target Accrual
302
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.