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

Phase 2

• Conditions: Small Cell Lung Cancer
• Interventions: Radiation: hippocampus avoidance

• Registration Number: NCT02906384
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-20
• Status Verified: 2016-10
• Study Start: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-10
• Primary Completion: 2018-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HA-PCI	hippocampus avoidance	PTV 25Gy/10F. Hippocampus avoidance: decrease the dose to HAZ as the following criteria: Dmin\<9Gy Dmax\<16Gy. Radiation technique: VMAT.

Primary Outcome Measures

Name	Time	Method
memory preservation	2 years	responses to Hopkins Verbal Learning Test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China