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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02906384
• Other study ID #: ZJCH-HA-PCI
• Status: Recruiting
• Phase: Phase 2
• First received: September 9, 2016
• Last updated: October 6, 2016
• Start date: October 2016
• Est. completion date: October 2020

Study information

• Verified date: October 2016
• Source: Zhejiang Cancer Hospital
• Contact: Ming Chen, PHD
• Phone: 0086-571-88122068
• Email: chenming[@]zjcc.org.cn
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Zhejiang Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: October 2020
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Radiation:
• hippocampus avoidance
conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	memory preservation	responses to Hopkins Verbal Learning Test	2 years	No
Secondary	overall survival	Overall survival will be evaluated	2 years	No
Secondary	hippocampus metastasis	hippocampus metastasis rate will be recorded	2 years	No
Secondary	image changes of brain	changes of functional brain MRI will be recorded.	2 years	No