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

NCT02736916 | Unknown DMC

• 1 other identifier: Radiation Oncology 20160101
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Small Cell Lung

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

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

  The metastatic rate between HS-WBRT and control group at 2 years following hippocampal-sparing PCI.

Study Arms (2)

HS-WBRT PCI

EXPERIMENTAL

LD-SCLC patients with HS-WBRT PCI

Radiation: HS-WBRT PCI

Conventional PCI

ACTIVE COMPARATOR

LD-SCLC patients with Conventional PCI

Radiation: Conventional PCI

Interventions

HS-WBRT PCI RADIATION

LD-SCLC patients with HS-WBRT PCI

HS-WBRT PCI

Conventional PCI RADIATION

LD-SCLC patients with conventional PCI

Conventional PCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ren Zhao, M.D.

  General Hospital of Ningxia Medical Universuty

  STUDY CHAIR

Central Study Contacts

Yan-Yang Wang, M.D.

CONTACT

86-951-6743315; fdwyy1981@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: April 13, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 13, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)