Whole-Brain Radiation Therapy With or Without Hippocampal Avoidance in Limited Stage or Extensive Stage Small Cell Lung Cancer

Completed · Phase 2/Phase 3

Conditions studied: Extensive Stage Small Cell Lung Carcinoma, Limited Stage Small Cell Lung Carcinoma

In brief

This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.

Key facts

Study ID

NCT02635009

Run by

NRG Oncology

People needed

418

Starts

2015-12-22

Expected to finish

2025-09-04

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
• Radiographic evidence of central nervous system (CNS) metastases
• Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
• Planned concurrent chemotherapy during PCI
• Concurrent atezolizumab permitted
• Concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted
• Contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia
• Severe, active comorbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Uncontrolled, clinically significant cardiac arrhythmias
• HIV positive with CD4 count < 200 cells/microliter;
• Note: Patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to Step 1 registration.
• Note: HIV testing is not required for eligibility for this protocol.
• Pregnant or lactating women or women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic.

Where it is running

• Lewis and Faye Manderson Cancer Center — Tuscaloosa, Alabama, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Marin General Hospital — Greenbrae, California, United States
• Los Angeles General Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Mercy Cancer Center — Merced, California, United States
• Kaiser Permanente Oakland-Broadway — Oakland, California, United States
• Saint Joseph Hospital - Orange — Orange, California, United States
• Kaiser Permanente-Rancho Cordova Cancer Center — Rancho Cordova, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States
• The Permanente Medical Group-Roseville Radiation Oncology — Roseville, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States
• Gene Upshaw Memorial Tahoe Forest Cancer Center — Truckee, California, United States
• Sutter Solano Medical Center/Cancer Center — Vallejo, California, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Hartford HealthCare - Saint Vincent's Medical Center — Bridgeport, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Boca Raton Regional Hospital — Boca Raton, Florida, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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