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

NCT ID: NCT02906384

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-10-31

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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

routine PCI

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

HA-PCI

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

Radiation technique: VMAT.

Group Type: EXPERIMENTAL

hippocampus avoidance

Intervention Type: RADIATION

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

Interventions

hippocampus avoidance

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming Chen, PHD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Yue Kong

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Chen, PHD

Role: CONTACT

chenming@zjcc.org.cn

0086-571-88122068

Yue Kong

Role: CONTACT

kongyue@zjcc.org.cn

0086-571-88128172

Facility Contacts

Ming Chen, PHD

Role: primary

chenming@zjcc.org.cn

Other Identifiers

ZJCH-HA-PCI

Identifier Type: -

Identifier Source: org_study_id