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Protocol No. NRGCC003

Principal Investigator Baschnagel, Andrew

Phase II/III

Age Group Adult

Scope National

Sponsor Type National

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

Objective The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole-brain radiation to the usual whole-brain radiation. The hippocampus is part of the brain that is important for memory. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. The first portion of this study will test if avoiding the hippocampus during whole-brain radiation is as effective as the usual treatment, whole-brain radiation, in decreasing the chance of cancer spreading to the brain. The second portion of the study will test if hippocampal avoidance decreases memory and thinking side effects.

Treatment People who are not in a study are usually treated with radiation to the whole brain to reduce the chance of the cancer spreading to the brain. The first portion of this study will test if avoiding the hippocampus during whole-brain radiation is as effective as the usual treatment, whole-brain radiation, in decreasing the chance of cancer spreading to the brain. The second portion of the study will test if hippocampal avoidance decreases memory and thinking side effects.

Description A computer will by chance assign you to treatment groups in the study. This is called randomization. Group 1 will receive whole-brain radiation (usual care). Group 2 will receive whole-brain radiation with hippocampal avoidance.

Key Eligibility
  • Histologic proof of small cell lung cancer within 250 days prior to registration
  • Patients must be registered on study no earlier than 7 days and no later than 56 days prior to registration after completing chemotherapy
  • Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage small cell lung cancer after clinical staging evaluation
  • Not eligible if patient received prior radiotherapy to the head or neck
  • Not eligible if radiographic evidence of CNS metastases or hydrocephalus

Applicable Disease Sites Lung

Therapies Involved Radiotherapy

Status Open

Participating Institutions Johnson Creek, UW Cancer Center; UW Hospital and Clinics