Clinical trial NCT02906384: Memory and MRI Changes With Hippocampus Avoidance Prophylactic Cranial Irradiation(HA-PCI) for Small Cell Lung Cancer(SCLC)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: hippocampus avoidance
volumetric modulated arc therapy
functional MRI
hopkins Verbal Learning Test
prophylactic cranial irradiation
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: memory preservation
timeFrame: 2 years
Secondary outcomes:
measure: overall survival
timeFrame: 2 years
measure: hippocampus metastasis
timeFrame: 2 years
measure: image changes of brain
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Ming Chen, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Cancer Hospital
name: Yue Kong
role: PRINCIPAL_INVESTIGATOR
References: