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HS-WBRT for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer

Primary Purpose

Carcinoma, Small Cell Lung

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HS-WBRT PCI
Conventional PCI
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Small Cell Lung

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General Hospital of Ningxia Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HS-WBRT PCI

Conventional PCI

Arm Description

LD-SCLC patients with HS-WBRT PCI

LD-SCLC patients with Conventional PCI

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluate the rate of brain metastasis in hippocampal region after HS-WBRT PCI for limited stage small cell lung cancer patients.

Full Information

First Posted
March 25, 2016
Last Updated
April 7, 2016
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02736916
Brief Title
HS-WBRT for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
Official Title
Hippocampal-Sparing Whole-Brain Radiation Therapy for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Ningxia Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Small Cell Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HS-WBRT PCI
Arm Type
Experimental
Arm Description
LD-SCLC patients with HS-WBRT PCI
Arm Title
Conventional PCI
Arm Type
Active Comparator
Arm Description
LD-SCLC patients with Conventional PCI
Intervention Type
Radiation
Intervention Name(s)
HS-WBRT PCI
Intervention Description
LD-SCLC patients with HS-WBRT PCI
Intervention Type
Radiation
Intervention Name(s)
Conventional PCI
Intervention Description
LD-SCLC patients with conventional PCI
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan-Yang Wang, M.D.
Phone
86-951-6743315
Email
fdwyy1981@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ren Zhao, M.D.
Organizational Affiliation
General Hospital of Ningxia Medical Universuty
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Wei, M.D.
Phone
86-951-6744528
Email
nyfykyc@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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HS-WBRT for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer

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