HS-WBRT for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
April 7, 2016 updated by: General Hospital of Ningxia Medical University
Hippocampal-Sparing Whole-Brain Radiation Therapy for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
Prophylactic cranial irradiation (PCI) is an important treatment modality of patients with limited stage small cell lung cancer (LD-SCLC).
However, PCI is also associated with several side effects, such as decline in memory and other cognitive functions.
This provides the rationale to explore the clinical feasibility of hippocampal avoidance during WBRT.
Previous studies have demonstrated the dosimetric capabilities of IMRT to conformally avoid the hippocampus without detriment to the radiation dose the remaining brain receives.
The aims of this study is to evaluate the therapy efficacy and the safety profile of hippocampal-sparing whole-brain radiation therapy (HS-WBRT) for PCI in patients with LD-SCLC.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Chemotherapy plus thoracic radiation followed by prophylactic cranial irradiation (PCI) is the standard of care in management of limited stage small cell lung cancer patients.
However, whole brain radiation therapy (WBRT) is also associated with many side effects including consolidation of new memory, poor attention span/concentration, visual spatial difficulties, difficulty with executive planning, and poor fine motor control.
There exists significant preclinical and clinical evidence that radiation induced injury to the hippocampus correlates with neurocognitive decline of patients who received WBRT.
Reducing radiation dose to the hippocampus during WBRT has been postulated as an approach to mitigate neurocognitive impairment.
The present study hypothesize that hippocampal sparing PCI will allow improved performance on tests of short term memory and executive function compared to a historical control receiving the same dose of conventional PCI.
The primary objective of this study is to evaluate performance on the Hopkins Verbal Learning Test-Revised for delayed recall at 6 months following hippocampal-sparing PCI relative to the historical control.
Secondary objectives are to estimate: composite cognitive function following hippocampal-sparing PCI relative to the historical control and the rate of metastases in the hippocampus at 2 years following hippocampal-sparing PCI.
Study Type
Interventional
Enrollment (Anticipated)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ningxia
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Yinchuan, Ningxia, China, 750004
- Recruiting
- General Hospital of Ningxia Medical University
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Contact:
- Jie Wei, M.D.
- Phone Number: 86-951-6744528
- Email: nyfykyc@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient must have newly diagnosed and confirmed small-cell lung cancer (SCLC)
- Patient must have a performance status of 1 or higher
- Patients must not have received previous irradiation to the brain
- Patients must have limited stage disease with CR (complete response) to chemotherapy and consolidative chest radiotherapy that was documented at least on standard chest x-rays within one month of study entry
- Negative MRI or CT scan of the brain at least one month before protocol entry
- Women of child-bearing potential must have a negative pregnancy test and also agree to use adequate contraceptives while on protocol
- Patient must be able to understand and sign the informed consent document
- Patient must be informed of the investigational aspect to this trial prior to singing the informed consent document
Exclusion Criteria:
- Patients receiving prior external beam irradiation to the head or neck, including any form of stereotactic irradiation
- Radiographic evidence of brain metastases and/or ipsilateral lung metastases/malignant pleural effusion
- Planned concurrent chemotherapy or antitumoral agent during PCI
- Concomitant malignancy or malignancy within the past five years other than nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Patients with minimal pleural effusion evident on CXR (chest X-ray); minimal pleural effusion visible on chest CT is allowed.
- Patients with epilepsy requiring permanent oral medication _ Patients must not have a serious medical or psychiatric illness that would, in the opinion of the investigator, prevent informed consent or completion of protocol treatment, and/or follow-up visits.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HS-WBRT PCI
LD-SCLC patients with HS-WBRT PCI
|
LD-SCLC patients with HS-WBRT PCI
|
|
Active Comparator: Conventional PCI
LD-SCLC patients with Conventional PCI
|
LD-SCLC patients with conventional PCI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVTL-R) 4 months after hippocampal sparing during whole-brain radiotherapy (HS-WBRT) for PCI of limited stage small cell lung cancer patients.
Time Frame: The change of the performance on the Hopkins Verbal Learning Test-Revised for delayed recall at 4 months following hippocampal-sparing PCI relative to the control group
|
The change of the performance on the Hopkins Verbal Learning Test-Revised for delayed recall at 4 months following hippocampal-sparing PCI relative to the control group
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate the rate of brain metastasis in hippocampal region after HS-WBRT PCI for limited stage small cell lung cancer patients.
Time Frame: The metastatic rate between HS-WBRT and control group at 2 years following hippocampal-sparing PCI.
|
The metastatic rate between HS-WBRT and control group at 2 years following hippocampal-sparing PCI.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ren Zhao, M.D., General Hospital of Ningxia Medical Universuty
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
March 25, 2016
First Submitted That Met QC Criteria
April 7, 2016
First Posted (Estimate)
April 13, 2016
Study Record Updates
Last Update Posted (Estimate)
April 13, 2016
Last Update Submitted That Met QC Criteria
April 7, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Radiation Oncology 20160101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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