Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04804644 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Final enrollment: 152 participants (planned 200) · Site details revised at 231 of 231 sitesv31 Show 2 more changesShow less
    • Final enrollment: 152 participants (planned 200)
    • Site details revised at 231 of 231 sites
  2. Completion pushed from Jul 1, 2030 to Jul 1, 2031v30
  3. Primary completion moved earlier from Jul 1, 2028 to Jun 24, 2026v29
  4. Trial sites expanded: 227 → 231 locationsv28
  5. Site details revised at 1 of 227 sitesv27
  6. Start date: Jun 10, 2021 to Jun 8, 2021v26
  7. Trial sites expanded: 224 → 227 locationsv25
  8. Study sites: 223 to 224v24
  9. Study sites revised (223)v23 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 214 to 223 Start date: Jun 8, 2021 to Jun 10, 2021 · Interventions: Biospecimen Collection (Procedure), Magnetic Resonance Imaging (Procedure), Memantine Hydrochloride (Drug), Neurocognitive Assessment… to Biospecimen Collection (Procedure), Magnetic Resonance Imaging (Procedure), Memantine Hydrochloride (Drug), Neurocognitive Assessment… · Secondary endpoints: details revised at 9 of 9 entriesv22 Show 3 more changesShow less
    • Start date: Jun 8, 2021 to Jun 10, 2021
    • Interventions: Biospecimen Collection (Procedure), Magnetic Resonance Imaging (Procedure), Memantine Hydrochloride (Drug), Neurocognitive Assessment… to Biospecimen Collection (Procedure), Magnetic Resonance Imaging (Procedure), Memantine Hydrochloride (Drug), Neurocognitive Assessment…
    • Secondary endpoints: details revised at 9 of 9 entries
  11. Study sites: 211 to 214v21
  12. Study sites: 205 to 211 Secondary endpoints: details revised at 2 of 9 entriesv20 Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 9 entries
  13. Study sites: 201 to 205 Start date: Jun 10, 2021 to Jun 8, 2021 · Interventions: Memantine Hydrochloride (Drug), Neurocognitive Assessment (Other), Stereotactic Radiosurgery (Radiation), Whole-Brain Radiotherapy… to Biospecimen Collection (Procedure), Magnetic Resonance Imaging (Procedure), Memantine Hydrochloride (Drug), Neurocognitive Assessment… · Eligibility criteria expanded, about 42 words · 3 morev19 Show 6 more changesShow less
    • Start date: Jun 10, 2021 to Jun 8, 2021
    • Interventions: Memantine Hydrochloride (Drug), Neurocognitive Assessment (Other), Stereotactic Radiosurgery (Radiation), Whole-Brain Radiotherapy… to Biospecimen Collection (Procedure), Magnetic Resonance Imaging (Procedure), Memantine Hydrochloride (Drug), Neurocognitive Assessment…
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: 7 to 9
    • Primary endpoint revised
    • Study description expanded, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 200 to 201v18
  15. Study sites: 157 to 200v17
  16. Start date: Jun 8, 2021 to Jun 10, 2021v16
  17. Start date: Mar 24, 2021 to Jun 8, 2021v15
  18. Primary completion date: Jul 1, 2025 to Jul 1, 2028v14
  19. Study sites: 146 to 157v13
  20. Study sites: 136 to 146v12
  21. Study sites revised (136)v11 See this version in full on ClinicalTrials.gov ↗
  22. Study sites: 134 to 136v10
  23. Study sites: 84 to 134v9
  24. Eligibility criteria shortened, about 18 wordsv8 See this version in full on ClinicalTrials.gov ↗
  25. Study sites: 66 to 84v7
  26. Study sites: 50 to 66v6
  27. Study sites: 31 to 50v5
  28. Study sites: 2 to 31v4
  29. Study sites: 1 to 2v3
  30. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  31. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.
Trial Details
NCT Number NCT04804644
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Recurrent Lung Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov