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

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

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 Contact

Study Locations

    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:

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

16 years to 78 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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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