Hippocampal Prophylactic Cranial Irradiation for Small Cell Lung Cancer

NCT ID: NCT01797159

Last Updated: 2021-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-11
• Study Completion Date: 2019-03-18

Brief Summary

The Investigators are looking to compare standard treatment for the management of small cell lung cancer (SCLC) which is prophylactic cranial Irradiation (PCI) (shown to be very good in patient survival) with cranial sparing PCI. Although standard of care PCI is successful in patient survival it also has neurologic side-effects. The Investigators are hoping the cranial sparing PCI has the same positive survival results with the added benefit of lowering neurological side-effects.

Detailed Description

The standard of care in management of small cell lung cancer consists of chemotherapy plus thoracic radiation followed by prophylactic cranial irradiation (PCI) based on a randomized trial that demonstrated a significant improvement in overall survival (OS) with PCI. Unfortunately radiation therapy to the brain is associated with neurocognitive toxicity, which may be at least in part related to radiation induced injury to neural progenitor cells in the hippocampus. Both human and animal data suggest an inverse relationship between radiation dose to the hippocampus and performance on neuropsychological testing. We hypothesize that hippocampal sparing PCI will allow improved performance on tests of short term memory and executive function compared to a historical control (RTOG 0212) 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: 1) composite cognitive function following hippocampal-sparing PCI relative to the historical control and 2) the rate of metastases in the hippocampus at 2 years following hippocampal-sparing PCI. The long term goal of this research is to reduce the long term sequelae of radiation therapy for both primary and metastatic brain tumors.

Conditions

Small-cell Lung Cancer; SCLC; Small Cell Lung Cancer Limited Stage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hippocampal-sparing PCI

Hippocampal-sparing PCI 25 Gy in 10 fractions

Group Type: EXPERIMENTAL

Hippocampal-sparing Prophylactic Cranial Irradiation

Intervention Type: RADIATION

Hippocampal-sparing Prophylactic Cranial Irradiation

Interventions

Hippocampal-sparing Prophylactic Cranial Irradiation

Hippocampal-sparing Prophylactic Cranial Irradiation

Intervention Type: RADIATION

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 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 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.
• Patients may not take Memantine. This is the only eligibility criterion that has been added to those of RTOG 0212, since some physicians might now prescribe Memantine. This medication would not have been given at the time of enrollment on RTOG 0212 and its administration could confound the results of this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Redmond, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Bayview Medical Center

Baltimore, Maryland, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

Redmond KJ, Hales RK, Anderson-Keightly H, Zhou XC, Kummerlowe M, Sair HI, Duhon M, Kleinberg L, Rosner GL, Vannorsdall T. Prospective Study of Hippocampal-Sparing Prophylactic Cranial Irradiation in Limited-Stage Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):603-611. doi: 10.1016/j.ijrobp.2017.03.009. Epub 2017 Mar 14.

Reference Type: DERIVED

PMID: 28581401 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NA_00078659

Identifier Type: OTHER

Identifier Source: secondary_id

J12127

Identifier Type: -

Identifier Source: org_study_id