Neurocognitive Function After Prophylactic Cranial Irradiation & Hippocampal Sparing in LD SCLC Patients - a Pilot Study

NCT02366741 | Unknown

• 1 other identifier: SMC-1476-14
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Small cell lung cancer (SCLC) harbors a high risk for brain metastases. Prophylactic whole brain radiotherapy (PCI)) is the standard treatment for these patients after completing chemo-radiotherapy to the chest, with a 5% survival advantage. Recent data suggest minimal risk for hippocampal involvement in these patients. There is no published data thus far testing the effect of hippocampal sparing during WBRT on the patient's neuro-cognitive function, QOL, and survival.., The goals of the proposed study are to assess prospectively the neurocognitive changes in patients with LD SCLC who are candidates for PCI before, and periodically after PCI

Conditions

Carcinoma, Small Cell

Keywords

SCLC; Neuro-cognitive function; PCI; Hippocampal sparing

Outcome Measures

Primary Outcomes (1)

• Number of patients that complete a year of imaging, neuro-cognitive and clinical follow up after WBRT with HC sparing as a measure of feasibility to conduct a randomized study in this patient population.

  1 year

Secondary Outcomes (3)

• Number of patients with no changes in the neurocognitive tests score and QOL as a measure for the correlation between NCT and HC sparing.

  1 year

• Number of patients with no changes in serum markers for neuronal damage and as a measure for reduced damage due to hippocampal sparing

  1 year

• Number of patients with changes in imaging biomarkers (TRAM) and neurocognitive tests score decline as a measure for a potential correlation between the two.

  1 year

Study Arms (1)

Pilot group

OTHER

Five eligible patients will undergo WBRT with reduced dose to the hippocampi and will be evaluated prospectively by neuro cognitive testing, MRI scans and blood tests.

Radiation: Whole brain radiotherapy with reduced dose to the hippocampi

Interventions

Whole brain radiotherapy with reduced dose to the hippocampi RADIATION

VMAT plan to treat the whole brain while reducing the dose to the hippocampi.

Pilot group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with histologically confirmed LD SCLC and complete response (CR) of the primary lesion after chemo-radiotherapy to the chest and who are candidates for PCI will be accrued

You may not qualify if:

• A history of malignant disease other then SCLC
• Previous cranial irradiation
• Medical or social condition which limits the ability of the patient to undergo neuro-cognitive testing

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5262100, Israel

RECRUITING

MeSH Terms

Conditions

Carcinoma, Small Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Leor Zach, MD

  Director of the Neuro-Oncology service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leor Zach, MD

CONTACT

leor.zach@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Neuro-Oncology service

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 19, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

IL (1)