Temozolomide Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost for Non Small Cell Lung Cancer Brain Metastases
Primary Purpose
Non Small Cell Lung Cancer Metastatic
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Temozolomide capsules
radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer Metastatic
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
RT groups
Drug plus RT groups
Arm Description
participants was given radiotherapy only,50Gy in 10 fractions over 2 weeks to metastases synchronously with 25Gy WBRT
Temozolomide capsules(Jiangsu tasly diyi pharmaceutical Co.,Ltd) Oral Temozolomide capsules 75mg/m2 begins on day 1 and continues until completion of radiotherapy.
Outcomes
Primary Outcome Measures
OS
overall survival
Secondary Outcome Measures
iPFS
intracranial Progress Free Survival
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.
overall response rate
use RECIST 1.1 version
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03732482
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taizhou Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RT groups
Arm Type
Placebo Comparator
Arm Description
participants was given radiotherapy only,50Gy in 10 fractions over 2 weeks to metastases synchronously with 25Gy WBRT
Arm Title
Drug plus RT groups
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Temozolomide capsules
Intervention Description
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
Device
Intervention Name(s)
radiotherapy
Intervention Description
Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost
Primary Outcome Measure Information:
Title
OS
Description
overall survival
Time Frame
Duration of time from the start of therapy 3 years or until time of death, whichever occurs first
Secondary Outcome Measure Information:
Title
iPFS
Description
intracranial Progress Free Survival
Time Frame
Duration of time from the start of therapy to the time of intracranial disease progression, assessed up to 3 years
Title
MMSE scores
Description
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.
Time Frame
up to 2 years
Title
overall response rate
Description
use RECIST 1.1 version
Time Frame
Up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haihua Yang, MD
Phone
13819639006
Email
yhh93181@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fengming(spring) Kong, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Zhu, MD
Organizational Affiliation
Taizhou Hospital, Wenzhou Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Temozolomide Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost for Non Small Cell Lung Cancer Brain Metastases
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