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

Non Small Cell Lung Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03732482
• Other study ID #: YHH-201807
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: March 1, 2019
• Est. completion date: May 30, 2022

Study information

• Verified date: January 2019
• Source: Taizhou Hospital
• Contact: Haihua Yang, MD
• Phone: 13819639006
• Email: yhh93181[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: May 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer Metastatic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taizhou Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	overall survival	Duration of time from the start of therapy 3 years or until time of death, whichever occurs first
Secondary	iPFS	intracranial Progress Free Survival	Duration of time from the start of therapy to the time of intracranial disease progression, assessed up to 3 years
Secondary	MMSE scores	mini mental state examination,The MMSE scores included 11 questions and was consisted of orientation to time (5 scores), orientation to place (5 scores), registration (3 scores), attention and calculation (5 scores), recall (3 scores), langue (2 scores), repetition (1 scores), complex commands (6 scores). The minimum score was 0, The maximum score was 30.	up to 2 years
Secondary	overall response rate	use RECIST 1.1 version	Up to 1 month