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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02906384

Enrollment

154

Registered

2016-09-20

Start date

2016-10-31

Completion date

2020-10-31

Last updated

2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Keywords

hippocampus avoidance, volumetric modulated arc therapy, functional MRI, hopkins Verbal Learning Test, prophylactic cranial irradiation

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.

Interventions

RADIATIONhippocampus avoidance

conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Histologically conformed small cell lung cancer; 2. Complete response (CR)/partial response (PR) after chemo-radiotherapy; 3. ECOG (Eastern Cooperative Oncology Group) : 0-1; 4. No imaging evidence of brain metastasis before PCI; 5. 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); 6. Able to understand this study and have signed informed consent.

Exclusion criteria

1. Unable to receive MRI; 2. Medical history of central nervous system, cognitive or psychological diseases; 3. The expectation of life is less than 6 months; 4. Female in pregnancy or lactating; 5. The researchers consider the patient not appropriate to be enrolled.

Design outcomes

Primary

Measure	Time frame	Description
memory preservation	2 years	responses to Hopkins Verbal Learning Test

Secondary

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

Countries

China

Contacts

Primary ContactMing Chen, PHD

chenming@zjcc.org.cn0086-571-88122068

Backup ContactYue Kong

kongyue@zjcc.org.cn0086-571-88128172

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026