Hippocampal-Sparing Prophylactic Cranial Irradiation in Pathologically Nodal Positive Non-Small-Cell Lung Cancer

NCT02448992 | Recruiting Phase 2

• 1 other identifier: 103-6591A3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Background. During the clinical course of patients with locoregionally advanced non-small-cell lung cancer (LA-NSCLC) who have undergone aggressive treatment, brain metastasis (BM) is a frequent seen pattern of disease relapse, which cannot be ignored. It still remains unresolved whether prophylactic cranial irradiation (PCI) via whole brain radiotherapy (WBRT) should be recommended for NSCLC patients with stage III or pathologically nodal positive disease. Actually, PCI would significantly decrease the incidence of BM; however, potential WBRT-related neurocognitive function (NCF) sequelae are indeed a concern, which has made PCI seldom applied in clinical practice. In terms of the time course of WBRT-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline principally involve impairments of episodic memory, which has been significantly associated with functions of the hippocampus. This study thus aims to explore the impact of PCI on the subsequent risk of developing BM and the multi-domain neurobehavioral functions in our eligible patients. Methods. Potentially eligible subjects are postoperative NSCLC patients with a status of pathologically nodal metastasis (pN+). Patients randomly assigned to the PCI arm will undergo the course of hippocampal-sparing PCI after they complete the fourth course of adjuvant platinum-based chemotherapy. Radiotherapy dose will be 3000 cGy in 15 fractions during three weeks. Except for the administration of hippocampal-sparing PCI, patients assigned to the observation arm should receive the same baseline and follow-up brain imaging examinations and neurocognitive assessments as those in PCI arm. Accordingly, a battery of neuropsychological measures, which includes 7 standardized neuropsychological tests (e.g., executive functions, verbal \& non-verbal memory, working memory, and psychomotor speed), is used to evaluate neurobehavioral functions for our registered patients. Expected results. This randomized controlled study aims to verify that the incidence of BM still can significantly be reduced by hippocampal-sparing PCI; additionally, NCF preservation regarding neurobehavioral assessments might also be achieved by hippocampal-sparing PCI as compared with the observation arm without PCI. No matter what the final results present, it is believed that this randomized controlled trial (RCT) will provide us solid evidence concerning the exact value of hippocampal-sparing PCI in our patient setting.

Conditions

Non-Small-Cell Lung Cancer (NSCLC); Brain Metastasis

Keywords

Neurobehavioral Assessments; Neurocognitive Functions (NCF); Prophylactic Cranial Irradiation (PCI); Hippocampus; Hippocampal-Sparing PCI

Outcome Measures

Primary Outcomes (1)

• time to the development of brain metastasis/metastases (BM), irrespective of the absence of active neurological symptoms

  one year

Secondary Outcomes (1)

• the effects of hippocampal-sparing PCI on neurocognitive functions (NCF)

  up to 18 months

Study Arms (2)

PCI via hippocampal-sparing WBRT

EXPERIMENTAL

All studied patients should undergo a computed tomography (CT) simulation scan encompassing the entire head region with 1.25-mm slice thickness using a thermoplastic mask for immobilization. To achieve conformal hippocampal sparing during the delivery of WBRT, the technique of volumetric modulated arc therapy (VMAT) via Linac-based RapidArc® or TrueBeamTM is employed in our treatment planning. All treatment plans are delivered by using the Linac Varian-iX or TrueBeamTM. In terms of dose prescription, a dose of 30 Gy in 15 fractions is prescribed to whole-brain planning target volume (PTV) under the setting of prophylactic cranial irradiation for NSCLC patients.

Radiation: hippocampal-sparing WBRT

observation without PCI

NO INTERVENTION

Interventions

hippocampal-sparing WBRT RADIATION

PCI via hippocampal-sparing WBRT

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of NSCLC
• Must be adult patients (≥ 18 years old) who have received definitive surgery and have a permanent pathology of nodal metastasis
• Platinum-based chemotherapy is mandatory
• Good performance status better than Eastern Cooperative Group (ECOG) of 2 or a general status of Karnofsky (KPS) \> 70 %
• Should have sufficient proficiency in Mandarin language

You may not qualify if:

• Have received prior cranial irradiation
• Presence of other active primary cancer (exception of basal cell carcinoma of skin and cervical carcinoma in situ)
• Radiographic evidence of brain metastasis/metastases
• Clinical evidence of extracranial metastatic disease
• Hypersensitivity to magnetic resonance (MR) contrast enhancer
• Serious medical or psychiatric illness

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Chi-Cheng Yang, Ph.D.

  Chang Gung University

  PRINCIPAL INVESTIGATOR

• Shinn-Yn Lin, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Cheng Yang, Ph.D.

CONTACT

886-988378478; ccyang@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: May 20, 2015
• Study Start: August 1, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

TW (1)