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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03732482
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Taizhou Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jian Zhu, MD
Principal Investigator Affiliation Taizhou Hospital, Wenzhou Medical University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Unknown status
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Non Small Cell Lung Cancer Metastatic
Arms & Interventions

Arms

Placebo Comparator: RT groups

participants was given radiotherapy only,50Gy in 10 fractions over 2 weeks to metastases synchronously with 25Gy WBRT

Experimental: Drug plus RT groups

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

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Haihua Yang, MD

[email protected]

13819639006

For additional contact information, you can also visit the trial on clinicaltrials.gov.