Clinical trial · Interventional
Hippocampal Prophylactic Cranial Irradiation for Small Cell Lung Cancer
"A Phase II Trial of Hippocampal-Sparing Cranial Irradiation (PCI) for Small-Cell Lung Cancer (SCLC)"
NCT01797159CI-TRIAL-00054516completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Investigators are looking to compare standard treatment for the management of small cell lung cancer (SCLC) which is prophylactic cranial Irradiation (PCI) (shown to be very good in patient survival) with cranial sparing PCI. Although standard of care PCI is successful in patient survival it also has neurologic side-effects. The Investigators are hoping the cranial sparing PCI has the same positive survival results with the added benefit of lowering neurological side-effects.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SCLC | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer Limited Stage | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hippocampal-sparing Prophylactic Cranial Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hippocampal-sparing PCI
- description
- Hippocampal-sparing PCI 25 Gy in 10 fractions
- interventionNames
- Radiation: Hippocampal-sparing Prophylactic Cranial Irradiation
Primary outcomes (1)
- measure
- Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall
- timeFrame
- Baseline, 6 months and 12 months post radiation treatment
- description
- The primary endpoint of this study is cognitive function or memory. Memory is measured by participant performance on the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-Delayed Recall) at 6 months following hippocampal-sparing PCI. The HVLT-Delayed minimum and Maximum scores are 0-12. A higher score means a better outcome.
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have newly diagnosed and confirmed small-cell lung cancer (SCLC) * Patient must have a performance status of 1 or higher * Patients must not have received previous irradiation to the brain * Patients must have limited stage disease with complete response to chemotherapy and consolidative chest radiotherapy that was documented at least on standard chest x-rays within one month of study entry * Negative MRI or CT scan of the brain at least one month before protocol entry * Women of child-bearing potential must have a negative pregnancy test and also agree to use adequate contraceptives while on protocol * Patient must be able to understand and sign the informed consent document * Patient must be informed of the investigational aspect to this trial prior to singing the informed consent document Exclusion Criteria: * Patients receiving prior external beam irradiation to the head or neck, including any form of stereotactic irradiation * Radiographic evidence of brain metastases and/or ipsilateral lung metastases/malignant pleural effusion * Planned concurrent chemotherapy or antitumoral agent during PCI * Concomitant malignancy or malignancy within the past five years other than nonmelanomatous skin cancer or carcinoma in situ of the cervix * Patients with minimal pleural effusion evident on chest X-ray; minimal pleural effusion visible on chest CT is allowed. * Patients with epilepsy requiring permanent oral medication * Patients must not have a serious medical or psychiatric illness that would, in the opinion of the investigator, prevent informed consent or completion of protocol treatment, and/or follow-up visits. * Patients may not take Memantine. This is the only eligibility criterion that has been added to those of RTOG 0212, since some physicians might now prescribe Memantine. This medication would not have been given at the time of enrollment on RTOG 0212 and its administration could confound the results of this study.
References
Publications (1)
- DERIVEDRedmond KJ, Hales RK, Anderson-Keightly H, Zhou XC, Kummerlowe M, Sair HI, Duhon M, Kleinberg L, Rosner GL, Vannorsdall T. Prospective Study of Hippocampal-Sparing Prophylactic Cranial Irradiation in Limited-Stage Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):603-611. doi: 10.1016/j.ijrobp.2017.03.009. Epub 2017 Mar 14. PMID 28581401