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

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

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.

Study Overview

• Status: Unknown
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Radiation: hippocampus avoidance

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 Type: Interventional
• Enrollment (Anticipated): 154
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Principal Investigator: Ming Chen, PHD
      • Contact: Ming Chen, PHD; Email: chenming@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: routine PCI; PTV:25Gy/10F. Radiation technique: VMAT.
Experimental: HA-PCI; PTV 25Gy/10F. Hippocampus avoidance: decrease the dose to HAZ as the following criteria: Dmin<9Gy Dmax<16Gy. Radiation technique: VMAT.	Radiation: hippocampus avoidance; conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
memory preservation	responses to Hopkins Verbal Learning Test	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	Overall survival will be evaluated	2 years
hippocampus metastasis	hippocampus metastasis rate will be recorded	2 years
image changes of brain	changes of functional brain MRI will be recorded.	2 years

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Ming Chen, PHD, Zhejiang Cancer Hospital; Principal Investigator: Yue Kong, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: functional MRI; prophylactic cranial irradiation; hippocampus avoidance; volumetric modulated arc therapy; hopkins Verbal Learning Test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: ZJCH-HA-PCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO