NRG-CC003

Terminated

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Protocol Information

Tab containing protocol details, study design, and eligibility criteria
Tab containing study documents, informed consent forms, and study materials
Tab containing information for potential study participants

Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer

Principal Investigator

Vinai Gondi, MD

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.


Patient Study Webpage

There is no available patient study webpage available for this trial at this time.