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

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ClinicalTrials.gov Identifier: NCT02736916
Recruitment Status : Unknown
Verified March 2016 by General Hospital of Ningxia Medical University.
Recruitment status was:  Recruiting
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
General Hospital of Ningxia Medical University

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Small Cell Lung Radiation: HS-WBRT PCI Radiation: Conventional PCI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hippocampal-Sparing Whole-Brain Radiation Therapy for Prophylactic Cranial Irradiation in Limited Stage Small Cell Lung Cancer
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: HS-WBRT PCI
LD-SCLC patients with HS-WBRT PCI
Radiation: HS-WBRT PCI
LD-SCLC patients with HS-WBRT PCI

Active Comparator: Conventional PCI
LD-SCLC patients with Conventional PCI
Radiation: Conventional PCI
LD-SCLC patients with conventional PCI




Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736916


Contacts
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Contact: Yan-Yang Wang, M.D. 86-951-6743315 fdwyy1981@hotmail.com

Locations
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China, Ningxia
General Hospital of Ningxia Medical University Recruiting
Yinchuan, Ningxia, China, 750004
Contact: Jie Wei, M.D.    86-951-6744528    nyfykyc@163.com   
Sponsors and Collaborators
General Hospital of Ningxia Medical University
Investigators
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Study Chair: Ren Zhao, M.D. General Hospital of Ningxia Medical Universuty

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Responsible Party: General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier: NCT02736916     History of Changes
Other Study ID Numbers: Radiation Oncology 20160101
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Carcinoma, Small Cell
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type