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

NCT03732482 | Unknown Phase 2

• 1 other identifier: YHH-201807
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• OS

  overall survival

  Duration of time from the start of therapy 3 years or until time of death, whichever occurs first

Secondary Outcomes (3)

• iPFS

  Duration of time from the start of therapy to the time of intracranial disease progression, assessed up to 3 years

• MMSE scores

  up to 2 years

• overall response rate

  Up to 1 month

Study Arms (2)

RT groups

PLACEBO COMPARATOR

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

Device: radiotherapy

Drug plus RT groups

EXPERIMENTAL

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

Drug: Temozolomide capsules

Interventions

Temozolomide capsules DRUG

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

Drug plus RT groups

radiotherapy DEVICE

Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost

RT groups

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taizhou Hospital: lead

MeSH Terms

Interventions

Temozolomide; Radiotherapy

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Jian Zhu, MD

  Taizhou Hospital, Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haihua Yang, MD

CONTACT

13819639006; yhh93181@hotmail.com

Fengming（spring） Kong, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of department of Radiation Oncology,chief physician,

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 6, 2018
• Study Start: March 1, 2019
• Primary Completion: January 31, 2022
• Study Completion: May 30, 2022
• Last Updated: January 29, 2019

Record last verified: 2019-01