Clinical trial NCT03732482: Temozolomide Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost for Non Small Cell Lung Cancer Brain Metastases
Official title: A Phase II/III Study of Non Small Cell Lung Cancer Patient With/Without Synchronous Oral Temozolomide Capsules Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost With Hippocampus Protection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Non Small Cell Lung Cancer Metastatic
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Patients must have an estimated survival of at least 4 weeks
2. Karnofsky Performance Status Scale (KPS) of 60-100.
3. Patients' laboratory values had to meet these restrictions: hemoglobin\>8 g/dL, platelets\>70\*109/L, white blood cells\>4\*109/L.
4. Patients must sign a study specific informed consent form prior to study entry

Exclusion Criteria:

1. Patients had major medical illnesses or psychiatric impairments which will prevent completion of the protocol therapy
2. had received previous brain irradiation
3. could not be regularly followed
4. with leptomeningeal involvement

Primary outcomes:
measure: OS
timeFrame: Duration of time from the start of therapy 3 years or until time of death, whichever occurs first
Secondary outcomes:
measure: iPFS
timeFrame: Duration of time from the start of therapy to the time of intracranial disease progression, assessed up to 3 years
measure: MMSE scores
timeFrame: up to 2 years
measure: overall response rate
timeFrame: Up to 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Taizhou Hospital, Wenzhou Medical University
name: Jian Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: