Clinical trial NCT02736916: HS-WBRT for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
Official title: Hippocampal-Sparing Whole-Brain Radiation Therapy for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Small Cell Lung
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Chemotherapy plus thoracic radiation followed by prophylactic cranial irradiation (PCI) is the standard of care in management of limited stage small cell lung cancer patients. However, whole brain radiation therapy (WBRT) is also associated with many side effects including consolidation of new memory, poor attention span/concentration, visual spatial difficulties, difficulty with executive planning, and poor fine motor control. There exists significant preclinical and clinical evidence that radiation induced injury to the hippocampus correlates with neurocognitive decline of patients who received WBRT. Reducing radiation dose to the hippocampus during WBRT has been postulated as an approach to mitigate neurocognitive impairment. The present study hypothesize that hippocampal sparing PCI will allow improved performance on tests of short term memory and executive function compared to a historical control receiving the same dose of conventional PCI. The primary objective of this study is to evaluate performance on the Hopkins Verbal Learning Test-Revised for delayed recall at 6 months following hippocampal-sparing PCI relative to the historical control. Secondary objectives are to estimate: composite cognitive function following hippocampal-sparing PCI relative to the historical control and the rate of metastases in the hippocampus at 2 years following hippocampal-sparing PCI.

Eligibility criteria: 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.

Primary outcomes:
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: The change of the performance on the Hopkins Verbal Learning Test-Revised for delayed recall at 4 months following hippocampal-sparing PCI relative to the control group
Secondary outcomes:
measure: Evaluate the rate of brain metastasis in hippocampal region after HS-WBRT PCI for limited stage small cell lung cancer patients.
timeFrame: The metastatic rate between HS-WBRT and control group at 2 years following hippocampal-sparing PCI.
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical Universuty
name: Ren Zhao, M.D.
role: STUDY_CHAIR
References: