Memory and MRI Changes With Hippocampus Avoidance Prophylactic Cranial Irradiation(HA-PCI) for Small Cell Lung Cancer(SCLC)

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized phase-II study observing the memory preservation and functional brain MRI changes with conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation for small cell lung cancer patients.

Detailed Description
-----------------
Brain metastasis is rather high in small cell lung cancer patients. Prophylactic cranial irradiation(PCI) is the standardized treatment. However, cognitive dysfunction like memory damage is observed in quite a number of patients after brain irradiation, which may due to the hippocampus being irradiated. Thus, the investigators conduct the study by reducing the dose to the hippocampal neural stem-cell compartment (HAZ) during PCI. Patient Population: Age: 18-65y; small cell lung cancer undergoing PCI; Eastern Cooperative Oncology Group (ECOG) score: 0-1. The patients are randomized to 2 arms: Arm Routine PCI: PTV(planning target volume) 25Gy/10F. Arm Hippocampus avoidance PCI(HA-PCI): PTV 25Gray(Gy)/10Fraction(F), HAZ Dmin<9Gy Dmax<16Gy). Measurements: Hopkins verbal learning test(HVLT) and functional brain magnetic resonance imaging.

Official Title
-----------------
Memory Preservation and Functional Brain Magnetic Resonance Imaging Changes With Conformal Avoidance of the Hippocampal Neural Stem-cell Compartment During Prophylactic Cranial Irradiation for Small Cell Lung Cancer Patients: A Prospective, Randomized Phase-II Study

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Radiation: hippocampus avoidance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically conformed small cell lung cancer; Complete response (CR)/partial response (PR) after chemo-radiotherapy; ECOG (Eastern Cooperative Oncology Group) : 0-1; No imaging evidence of brain metastasis before PCI; Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function); Able to understand this study and have signed informed consent. Exclusion Criteria: Unable to receive MRI; Medical history of central nervous system, cognitive or psychological diseases; The expectation of life is less than 6 months; Female in pregnancy or lactating; The researchers consider the patient not appropriate to be enrolled.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: routine PCI<br>PTV:25Gy/10F. Radiation technique: VMAT. | |
| Experimental: HA-PCI<br>PTV 25Gy/10F. Hippocampus avoidance: decrease the dose to HAZ as the following criteria: Dmin<9Gy Dmax<16Gy. Radiation technique: VMAT. | Radiation: hippocampus avoidance<br>* conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| memory preservation | responses to Hopkins Verbal Learning Test | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | Overall survival will be evaluated | 2 years | 
| hippocampus metastasis | hippocampus metastasis rate will be recorded | 2 years | 
| image changes of brain | changes of functional brain MRI will be recorded. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hippocampus avoidance, volumetric modulated arc therapy, functional MRI, hopkins Verbal Learning Test, prophylactic cranial irradiation