Clinical trial · Interventional
HS-WBRT for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
Hippocampal-Sparing Whole-Brain Radiation Therapy for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
- 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)
Prophylactic cranial irradiation (PCI) is an important treatment modality of patients with limited stage small cell lung cancer (LD-SCLC). However, PCI is also associated with several side effects, such as decline in memory and other cognitive functions. This provides the rationale to explore the clinical feasibility of hippocampal avoidance during WBRT. Previous studies have demonstrated the dosimetric capabilities of IMRT to conformally avoid the hippocampus without detriment to the radiation dose the remaining brain receives. The aims of this study is to evaluate the therapy efficacy and the safety profile of hippocampal-sparing whole-brain radiation therapy (HS-WBRT) for PCI in patients with LD-SCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Small Cell Lung | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional PCI | Radiation | — | UNRESOLVED |
| HS-WBRT PCI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HS-WBRT PCI
- description
- LD-SCLC patients with HS-WBRT PCI
- interventionNames
- Radiation: HS-WBRT PCI
- type
- ACTIVE_COMPARATOR
- label
- Conventional PCI
- description
- LD-SCLC patients with Conventional PCI
- interventionNames
- Radiation: Conventional PCI
Primary outcomes (1)
- measure
- Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVTL-R) 4 months after hippocampal sparing during whole-brain radiotherapy (HS-WBRT) for PCI of limited stage small cell lung cancer patients.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 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 CR (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 CXR (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.
References
Publications (0)
Data not yet available