NCT02448992 Hippocampal-Sparing Prophylactic Cranial Irradiation in Pathologically Nodal Positive Non-Small-Cell Lung Cancer
| NCT ID | NCT02448992 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Non-Small-Cell Lung Cancer (NSCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2015-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2015-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Chi-Cheng Yang, Ph.D.
PRINCIPAL INVESTIGATOR
Chang Gung University
Frequently Asked Questions
Who can join the NCT02448992 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Non-Small-Cell Lung Cancer (NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02448992 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02448992 currently recruiting?
Yes, NCT02448992 is actively recruiting participants. Contact the research team at ccyang@mail.cgu.edu.tw for enrollment information.
Where is the NCT02448992 trial being conducted?
This trial is being conducted at Taoyuan, Taiwan.
Who is sponsoring the NCT02448992 clinical trial?
NCT02448992 is sponsored by Chang Gung Memorial Hospital. The principal investigator is Chi-Cheng Yang, Ph.D. at Chang Gung University. The trial plans to enroll 90 participants.
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