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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| routine PCI | No Intervention | PTV:25Gy/10F. Radiation technique: VMAT. | |
| HA-PCI | Experimental | PTV 25Gy/10F. Hippocampus avoidance: decrease the dose to HAZ as the following criteria: Dmin<9Gy Dmax<16Gy. Radiation technique: VMAT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hippocampus avoidance | Radiation | conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| memory preservation | responses to Hopkins Verbal Learning Test | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Overall survival will be evaluated | 2 years |
| hippocampus metastasis | hippocampus metastasis rate will be recorded | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Chen, PHD | Contact | 0086-571-88122068 | chenming@zjcc.org.cn | |
| Yue Kong | Contact | 0086-571-88128172 | kongyue@zjcc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Chen, PHD | Zhejiang Cancer Hospital | Principal Investigator |
| Yue Kong | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| image changes of brain | changes of functional brain MRI will be recorded. | 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |