Clinical trial No longer in our active list Phase 3 Interventional Ages 18 and up

High dose radiation for brain cancer vs whole brain radiation to protect memory

Official title: Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for Brain Metastases From Small Cell Lung Cancer

Run by NRG Oncology · NCT04804644 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing whether a high dose radiation treatment for brain cancer can better protect memory compared to the standard whole brain radiation therapy for patients with small cell lung cancer that has spread to the brain.

More Stage IV Lung Cancer AJCC v8 trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorNRG Oncology
Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations227 sites (Phoenix, Arizona and 226 other locations)
Trial IDNCT04804644 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with a confirmed diagnosis of small cell lung cancer and brain metastases that meet specific size and location criteria.

Probably not a fit

Patients with larger brain metastases or those whose cancer has progressed beyond the eligibility criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial compares the effectiveness of stereotactic radiosurgery (SRS) against whole brain radiation therapy with hippocampal avoidance (HA-WBRT) plus memantine for patients with small cell lung cancer that has metastasized to the brain. The study aims to determine whether SRS can better prevent cognitive decline and preserve memory function compared to the standard treatment. Participants will undergo various cognitive assessments and symptom evaluations to measure the impact of each treatment approach. The trial includes patients with brain metastases that meet specific size and location criteria.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive outcomes and quality of life for patients with brain metastases from small cell lung cancer.

How similar studies have gone: Other studies have shown promise in using stereotactic radiosurgery for brain metastases, suggesting potential benefits in cognitive preservation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis);

  * Patients with de novo or recurrent small cell lung cancer are permitted.
* Brain metastases =\< 4 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =\< 21 days prior to study entry.

  * The total tumor volume must be 30 cm\^3 or less. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g. xyz/2). Alternatively, direct volumetric measurements via slice by slice contouring on a treatment planning software package can be used to calculate the total tumor volume.
  * Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer.
  * Brain metastases must be diagnosed on MRI, which will include the following elements:

    * REQUIRED MRI ELEMENTS

      * Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (Brain Volume Imaging) or 3D Fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm.
      * Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged).
      * A minimum of one axial T2 FLAIR (preferred) or T2 sequence is required. This can be acquired as a two dimensional (2D) or 3D image. If 2D, the images should be obtained in the axial plane.
    * ADDITIONAL RECOMMENDATIONS

      * Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence.
      * Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1.
      * Recommendation is that imaging be performed on a 3 Tesla (3T) MRI.
      * Recommendation is that the study participants be scanned on the same MRI instrument at each time point.
      * Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020.
      * If additional sequences are obtained, total imaging time should not exceed 60 minutes.
      * If additional metastases not known at the time of registration/randomization or seen in the MRI used for eligibility are subsequently found on the radiation therapy (RT) planning MRI such that the total intacranial volume exceeds 30 cm\^3, the patient is still considered eligible.
* History/physical examination
* Age \>= 18
* Karnofsky performance status of \>= 70
* Creatinine clearance \>= 30 ml/min
* Following the diagnosis of brain metastases, patients can initiate and treat with systemic (chemotherapy and/or immunotherapy) before enrollment only if their brain metastases are asymptomatic and not located in eloquent locations (e.g., brainstem, pre-/post-central gyrus, visual cortex). However, within 21 days prior to enrollment, brain MRI must be repeated to confirm eligibility.

  * Patients with symptomatic brain metastases and/or brain metastases in eloquent locations (e.g., brainstem, pre-/post central gyrus, visual cortex) are eligible for enrollment on the trial; however, the specific treatment approach of starting with systemic therapy alone and delaying brain radiation is not recommended for these patients.
* Concurrent immunotherapy with brain radiation (SRS or HA-WBRT) is permitted.
* Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to registration. Women of childbearing potential and men who are sexually active must use contraception while on study.
* Patients may have had prior intracranial surgical resection.
* Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian.
* The patient must provide study-specific informed consent prior to study entry.

  * Patients with impaired decision-making capacity are not permitted on study.
* ELIGIBILITY CRITERIA PRIOR TO STEP 2 REGISTRATION
* The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive test will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.

  * NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.
* PRIOR TO STEP 2 REGISTRATION: The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive tests will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2.

NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.

Exclusion Criteria:

* Planned infusion of cytotoxic chemotherapy on the same day as SRS or HA-WBRT treatment. Patients may have had prior chemotherapy. Concurrent immunotherapy is permitted.

  * For patients receiving fractionated SRS on an every-other-day basis, planned infusion of cytotoxic chemotherapy is not permitted between SRS treatments.
* Brainstem metastasis \> 10 cm\^3
* Prior allergic reaction to memantine.
* Patients with definitive leptomeningeal metastases.
* Known history of demyelinating disease such as multiple sclerosis.
* Contraindication to MR imaging such as implanted metal devices that are MRI-incompatible, allergy to MRI contrast that cannot be adequately addressed with pre-contrast medications, or foreign bodies that preclude MRI imaging. (Questions regarding MRI compatibility of implanted objects should be reviewed with the Radiology Department performing the MRI).
* Current use of (other N-methyl-D-aspartate \[NMDA\] antagonists) amantadine, ketamine, or dextromethorphan.
* Radiographic evidence of hydrocephalus or other architectural change of the ventricular system resulting in significant anatomic distortion of the hippocampus, including placement of external ventricular drain or ventriculoperitoneal shunt.

  * Mild cases of hydrocephalus not resulting in significant anatomic distortion of the hippocampus are permitted.
* Prior radiotherapy to the brain, including SRS, WBRT, or prophylactic cranial irradiation (PCI).

Where it's running

  • Kaiser Permanente-Anaheim
    Anaheim, California, United States
    Recruiting
  • Kaiser Permanente-Bellflower
    Bellflower, California, United States
    Recruiting
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California, United States
    Recruiting
  • Los Angeles General Medical Center
    Los Angeles, California, United States
    Recruiting
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California, United States
    Recruiting
  • Kaiser Permanente-Ontario
    Ontario, California, United States
    Recruiting
Show 44 more locations
  • Moffitt Cancer Center-International Plaza
    Tampa, Florida, United States
    Recruiting
  • Moffitt Cancer Center - McKinley Campus
    Tampa, Florida, United States
    Recruiting
  • Moffitt Cancer Center
    Tampa, Florida, United States
    Recruiting
  • Moffitt Cancer Center at Wesley Chapel
    Wesley Chapel, Florida, United States
    Recruiting
  • Northside Hospital
    Atlanta, Georgia, United States
    Recruiting
  • Northside Hospital-Cherokee
    Canton, Georgia, United States
    Recruiting
  • Northside Hospital-Forsyth
    Cumming, Georgia, United States
    Recruiting
  • Rush-Copley Medical Center
    Aurora, Illinois, United States
    Recruiting
  • Centralia Oncology Clinic
    Centralia, Illinois, United States
    Recruiting
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois, United States
    Recruiting
  • Carle at The Riverfront
    Danville, Illinois, United States
    Recruiting
  • Cancer Care Specialists of Illinois - Decatur
    Decatur, Illinois, United States
    Recruiting
  • Decatur Memorial Hospital
    Decatur, Illinois, United States
    Recruiting
  • Northwestern Medicine Cancer Center Kishwaukee
    DeKalb, Illinois, United States
    Recruiting
  • Carle Physician Group-Effingham
    Effingham, Illinois, United States
    Recruiting
  • Crossroads Cancer Center
    Effingham, Illinois, United States
    Recruiting
  • Northwestern Medicine Cancer Center Delnor
    Geneva, Illinois, United States
    Recruiting
  • Carle Physician Group-Mattoon/Charleston
    Mattoon, Illinois, United States
    Recruiting
  • UC Comprehensive Cancer Center at Silver Cross
    New Lenox, Illinois, United States
    Recruiting
  • Cancer Care Center of O'Fallon
    O'Fallon, Illinois, United States
    Recruiting
  • HSHS Saint Elizabeth's Hospital
    O'Fallon, Illinois, United States
    Recruiting
  • OSF Saint Francis Medical Center
    Peoria, Illinois, United States
    Recruiting
  • Carle Cancer Center
    Urbana, Illinois, United States
    Recruiting
  • The Carle Foundation Hospital
    Urbana, Illinois, United States
    Recruiting
  • Northwestern Medicine Cancer Center Warrenville
    Warrenville, Illinois, United States
    Recruiting
  • IU Health West Hospital
    Avon, Indiana, United States
    Recruiting
  • IU Health North Hospital
    Carmel, Indiana, United States
    Recruiting
  • Goshen Center for Cancer Care
    Goshen, Indiana, United States
    Recruiting
  • Indiana University/Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana, United States
    Recruiting
  • IU Health Methodist Hospital
    Indianapolis, Indiana, United States
    Recruiting
  • Mary Greeley Medical Center
    Ames, Iowa, United States
    Recruiting
  • McFarland Clinic - Ames
    Ames, Iowa, United States
    Recruiting
  • The James Graham Brown Cancer Center at University of Louisville
    Louisville, Kentucky, United States
    Recruiting
  • UofL Health Medical Center Northeast
    Louisville, Kentucky, United States
    Recruiting
  • Mary Bird Perkins Cancer Center
    Baton Rouge, Louisiana, United States
    Recruiting
  • University of Maryland/Greenebaum Cancer Center
    Baltimore, Maryland, United States
    Recruiting
  • UM Upper Chesapeake Medical Center
    Bel Air, Maryland, United States
    Recruiting
  • Central Maryland Radiation Oncology in Howard County
    Columbia, Maryland, United States
    Recruiting
  • University of Maryland Shore Medical Center at Easton
    Easton, Maryland, United States
    Recruiting
  • UM Baltimore Washington Medical Center/Tate Cancer Center
    Glen Burnie, Maryland, United States
    Recruiting
  • Boston Medical Center
    Boston, Massachusetts, United States
    Recruiting
  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
    Ann Arbor, Michigan, United States
    Recruiting
  • McLaren Cancer Institute-Bay City
    Bay City, Michigan, United States
    Recruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton
    Brighton, Michigan, United States
    Recruiting

+177 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Vinai Gondi — NRG Oncology

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.