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

NCT ID: NCT03732482

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2022-05-30

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.

Conditions

Non Small Cell Lung Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RT groups

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

Group Type: PLACEBO_COMPARATOR

radiotherapy

Intervention Type: DEVICE

Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost

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.

Group Type: EXPERIMENTAL

Temozolomide capsules

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

radiotherapy

Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taizhou Hospital

OTHER

Sponsor Role: lead

Responsible Party

Haihua Yang

head of department of Radiation Oncology,chief physician,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Taizhou Hospital, Wenzhou Medical University

Central Contacts

Haihua Yang, MD

Role: CONTACT

yhh93181@hotmail.com

13819639006

Fengming（spring） Kong, MD

Role: CONTACT

Other Identifiers

YHH-201807

Identifier Type: -

Identifier Source: org_study_id