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
1 other identifier
interventional
154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedOctober 10, 2016
October 1, 2016
2 years
September 9, 2016
October 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
memory preservation
responses to Hopkins Verbal Learning Test
2 years
Secondary Outcomes (3)
overall survival
2 years
hippocampus metastasis
2 years
image changes of brain
2 years
Study Arms (2)
routine PCI
NO INTERVENTIONPTV:25Gy/10F. Radiation technique: VMAT.
HA-PCI
EXPERIMENTALPTV 25Gy/10F. Hippocampus avoidance: decrease the dose to HAZ as the following criteria: Dmin\<9Gy Dmax\<16Gy. Radiation technique: VMAT.
Interventions
conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming Chen, PHD
Zhejiang Cancer Hospital
- PRINCIPAL INVESTIGATOR
Yue Kong
Zhejiang Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2016
First Posted
September 20, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2018
Study Completion
October 1, 2020
Last Updated
October 10, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share