Back to resultsMemory and MRI Changes With Hippocampus Avoidance Prophylactic Cranial Irradiation(HA-PCI) for Small Cell Lung Cancer(SCLC)
Primary Purpose
Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
hippocampus avoidance
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring hippocampus avoidance, volumetric modulated arc therapy, functional MRI, hopkins Verbal Learning Test, prophylactic cranial irradiation
Eligibility Criteria
Inclusion Criteria:
- Histologically conformed small cell lung cancer;
- Complete response (CR)/partial response (PR) after chemo-radiotherapy;
- ECOG (Eastern Cooperative Oncology Group) : 0-1;
- No imaging evidence of brain metastasis before PCI;
- 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);
- Able to understand this study and have signed informed consent.
Exclusion Criteria:
- Unable to receive MRI;
- Medical history of central nervous system, cognitive or psychological diseases;
- The expectation of life is less than 6 months;
- Female in pregnancy or lactating;
- The researchers consider the patient not appropriate to be enrolled.
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
routine PCI
HA-PCI
Arm Description
PTV:25Gy/10F. Radiation technique: VMAT.
PTV 25Gy/10F. Hippocampus avoidance: decrease the dose to HAZ as the following criteria: Dmin<9Gy Dmax<16Gy. Radiation technique: VMAT.
Outcomes
Primary Outcome Measures
memory preservation
responses to Hopkins Verbal Learning Test
Secondary Outcome Measures
overall survival
Overall survival will be evaluated
hippocampus metastasis
hippocampus metastasis rate will be recorded
image changes of brain
changes of functional brain MRI will be recorded.
Full Information
NCT ID
NCT02906384
First Posted
September 9, 2016
Last Updated
October 6, 2016
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02906384
Brief Title
Memory and MRI Changes With Hippocampus Avoidance Prophylactic Cranial Irradiation(HA-PCI) for Small Cell Lung Cancer(SCLC)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
hippocampus avoidance, volumetric modulated arc therapy, functional MRI, hopkins Verbal Learning Test, prophylactic cranial irradiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
routine PCI
Arm Type
No Intervention
Arm Description
PTV:25Gy/10F. Radiation technique: VMAT.
Arm Title
HA-PCI
Arm Type
Experimental
Arm Description
PTV 25Gy/10F. Hippocampus avoidance: decrease the dose to HAZ as the following criteria: Dmin<9Gy Dmax<16Gy.
Radiation technique: VMAT.
Intervention Type
Radiation
Intervention Name(s)
hippocampus avoidance
Intervention Description
conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation
Primary Outcome Measure Information:
Title
memory preservation
Description
responses to Hopkins Verbal Learning Test
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall survival
Description
Overall survival will be evaluated
Time Frame
2 years
Title
hippocampus metastasis
Description
hippocampus metastasis rate will be recorded
Time Frame
2 years
Title
image changes of brain
Description
changes of functional brain MRI will be recorded.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically conformed small cell lung cancer;
Complete response (CR)/partial response (PR) after chemo-radiotherapy;
ECOG (Eastern Cooperative Oncology Group) : 0-1;
No imaging evidence of brain metastasis before PCI;
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);
Able to understand this study and have signed informed consent.
Exclusion Criteria:
Unable to receive MRI;
Medical history of central nervous system, cognitive or psychological diseases;
The expectation of life is less than 6 months;
Female in pregnancy or lactating;
The researchers consider the patient not appropriate to be enrolled.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Chen, PHD
Phone
0086-571-88122068
Email
chenming@zjcc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Kong
Phone
0086-571-88128172
Email
kongyue@zjcc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Chen, PHD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yue Kong
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Chen, PHD
Email
chenming@zjcc.org.cn
First Name & Middle Initial & Last Name & Degree
Ming Chen, PHD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Memory and MRI Changes With Hippocampus Avoidance Prophylactic Cranial Irradiation(HA-PCI) for Small Cell Lung Cancer(SCLC)
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