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COMPLETED

NCT02635009

PHASE2/PHASE3

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

Sponsor: NRG Oncology

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

418

Start Date

2015-12-22

Completion Date

2025-09-04

Last Updated

2026-07-10

Healthy Volunteers

Conditions

Extensive Stage Small Cell Lung Carcinoma Limited Stage Small Cell Lung Carcinoma

Interventions

RADIATION

Three-Dimensional Conformal Radiation Therapy

daily fractions

RADIATION

Intensity-Modulated Radiation Therapy

daily fractions

Inclusion Criteria \[prior to Step 1 registration\]: * Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration * High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted. * Patients must have received chemotherapy and be registered to Step 1 registration no earlier than 7 days and no later than 56 days after completing chemotherapy. Note: * Post-chemotherapy restaging imaging must be completed no more than 56 days prior to Step 1 registration. * For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted. * Patients must have a gadolinium contrast-enhanced three-dimensional (3D), spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan. To yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE or TFE axial MRI scan must use the smallest possible axial slice thickness not exceeding 1.5 mm. * This MRI must be obtained within 56 days prior to Step 1 registration. Note: The MRI study is mandatory irrespective of randomization to the experimental or control arm of this study. * Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following: 1. History/physical examination; 2. CT of the chest and abdomen with contrast (does not have to be done if the patient has had a positron emission tomography (PET) / CT scan prior to initiating chemotherapy or thoracic radiotherapy); 3. MRI of the brain with contrast or diagnostic head CT with contrast; 4. For patients without evidence of extensive-stage SCLC on chest and abdomen CT and brain MRI or head CT, a PET/CT or bone scan is required to confirm limited-stage SCLC. * After chemotherapy, patients must be restaged prior to Step 1 registration using the same diagnostic work-up as required pre-chemotherapy. Repeat PET/CT or bone scan is not required. Patients must have: * History/physical examination within 30 days of Step 1 registration; * No CNS metastases (Repeat MRI required) within 56 days prior to Step 1 registration; * No progression in any site; * Radiographic partial or complete response to chemotherapy in at least one disease site within 56 days prior to Step 1 registration. 1. If PET/CT was obtained prior to chemotherapy, either a repeat PET/CT or CT of the chest and abdomen with contrast can be obtained for response assessment. 2. Patients who underwent resection for limited-stage SCLC prior to chemotherapy and have no radiographically evident disease for response assessment remain eligible if post-chemotherapy imaging demonstrates no progression. * Zubrod performance status 0-2 within 30 days prior to Step 1 registration. * Women of childbearing potential must have a negative qualitative serum pregnancy test =\< 14 days prior to Step 1 registration. * Patients who are primary English or French speakers are eligible * Patients must sign a study-specific informed consent prior to study entry Inclusion Criteria \[prior to Step 2 registration\]: * The following baseline neurocognitive assessments must be completed and uploaded within 10 calendar days after or at the time of Step 1 registration: HVLT-R (recall, delayed recall, and recognition), TMT (Parts A and B), and COWA. The neurocognitive assessments will be uploaded into the NRG Oncology Rave System for evaluation by Neurocognitive Co-Chair. Once the upload is complete, within 3 business days, a notification email will be sent to the site to proceed to Step 2 registration. At minimum, the HVLT-R delayed recall must be able to be scored (i.e. completed without error) in order to be eligible. * Patients must have a baseline raw score greater than 2 on the HVLT-R delayed recall as determined by central assessment by the Neurocognitive Co-Chair. Exclusion Criteria: * 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; 1. 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. 2. 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.

Locations (281)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

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

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Grady Health System