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Temozolomide Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost for Non Small Cell Lung Cancer Brain Metastases

NCT03732482 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2019-01-29

No results posted yet for this study

Summary

With the improvement of systemic therapeutic effect(especially in the population with driver gene mutation), the incidence of brain metastases had significantly increased. Conventional Whole Brain radiotherapy(WBRT) was less effective, the stereotactic radiosurgery(SRS) technique had improve the local efficacy for 1-3 lesions, but the probability of intracranial recurrence was increased, Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost(SIB-IMRT) is a new radiotherapy technology, Giving a standard radiation dose of whole brain ,at the same time can boost the high-risk region in target, So that it can significantly shorten the treatment time, at the same time can improve the local control rate of brain metastases. In the aspect of normal tissue protecting, SIB was better than WBRT plus SRS sequential treatment pattern. 30Gy to the whole brain had a negative effects on cognitive function, the investigators previous study found that 25Gy to the whole brain while the tumor bed Simultaneous push to 50Gy was safe and effective, while reducing the impact on cognitive function. Hippocampus is a part of the brain located in the temporal lobe, Mainly responsible for long-term memory storage conversion and orientation. Many investigators point out that hippocampus is the main commander of neurocognitive function, Reduce the dose of hippocampus can significant improve the neurocognitive function. Temozolomide capsule is an anti-tumor alkylation agent for glioblastoma multiforme and anaplastic astrocytoma. In recent years, some researchers find that Temozolomide capsules combine with radiotherapy such as SRS, WBRT or The two combined, can improve Objective response(OR) and prolong the Progress Free Survival(PFS),while with tolerable therapeutic toxicity. In order to better reduce the impact on cognitive function and improve the local control rate, the investigators present this trial, under the SIB-IMRT technique, the investigators want to explore the effect of temozolomide in brain metastasis of non-small cell lung cancer with the hippocampal protection technology.

Conditions

  • Non Small Cell Lung Cancer Metastatic

Interventions

DRUG

Temozolomide capsules

Temozolomide capsules(Jiangsu tasly diyi pharmaceutical Co.,Ltd) Oral Temozolomide capsules 75mg/m2 begins on day 1 and continues until completion of radiotherapy.

DEVICE

radiotherapy

Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost

Sponsors & Collaborators

  • Taizhou Hospital

    lead OTHER

Principal Investigators

  • Jian Zhu, MD · Taizhou Hospital, Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2022-01-31
Completion
2022-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03732482 on ClinicalTrials.gov