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

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Radiation: hippocampus avoidance

Study type: Interventional

Funder types: Other

Identifiers

NCT02906384

ZJCH-HA-PCI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

routine PCI

No Intervention group

Description:

PTV:25Gy/10F. Radiation technique: VMAT.

HA-PCI

Experimental group

Description:

PTV 25Gy/10F. Hippocampus avoidance: decrease the dose to HAZ as the following criteria: Dmin\<9Gy Dmax\<16Gy. Radiation technique: VMAT.

Treatment:

Radiation: hippocampus avoidance