Non Small Cell Lung Cancer MetastaticPhase 2/3NCT03732482
Temozolomide Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost for Non Small Cell Lung Cancer Brain Metastases
A Phase 2/3 study testing Temozolomide capsules and radiotherapy in people with Non Small Cell Lung Cancer Metastatic, run by Taizhou Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Small Cell Lung Cancer Metastatic
- What is being tested?
- Temozolomide capsules and radiotherapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 30 May 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Fengming（spring） Kong, MD contact
About this study
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
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
- Being tested
- Temozolomide capsules, radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temozolomide capsulesDrug
Temozolomide capsules(Jiangsu tasly diyi pharmaceutical Co.,Ltd) Oral Temozolomide capsules 75mg/m2 begins on day 1 and continues until completion of radiotherapy.
radiotherapyDevice
Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost
| Study group | Role | What they receive |
|---|---|---|
| RT groups | Placebo comparator | participants was given radiotherapy only,50Gy in 10 fractions over 2 weeks to metastases synchronously with 25Gy WBRT Receives: 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. Receives: Drug: Temozolomide capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
overall survival
Measured: Duration of time from the start of therapy 3 years or until time of death, whichever occurs first
Secondary outcomes (3)
iPFS
intracranial Progress Free Survival
Measured: Duration of time from the start of therapy to the time of intracranial disease progression, assessed up to 3 years
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.
Measured: up to 2 years
overall response rate
use RECIST 1.1 version
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Mar 2019 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihua Yang, Taizhou Hospital
- Investigators
- Jian Zhu, MD, Principal investigator, Taizhou Hospital, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732482
- Sponsor's protocol ID
- YHH-201807
- Status last verified
- Jan 2019
- First submitted
- 2 Nov 2018
- Last updated
- 29 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03732482
- Acronym / sponsor ID
- YHH-201807
- Conditions
- Non Small Cell Lung Cancer Metastatic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT groups | Placebo comparator | Device: radiotherapyparticipants was given radiotherapy only,50Gy in 10 fractions over 2 weeks to metastases synchronously with 25Gy WBRT |
| Drug plus RT groups | Experimental | Drug: Temozolomide capsulesTemozolomide capsules(Jiangsu tasly diyi pharmaceutical Co.,Ltd) Oral Temozolomide capsules 75mg/m2 begins on day 1 and continues until completion of radiotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temozolomide capsulesTemozolomide capsules(Jiangsu tasly diyi pharmaceutical Co.,Ltd) Oral Temozolomide capsules 75mg/m2 begins on day 1 and continues until completion of radiotherapy. | Drug | Drug plus RT groups |
| radiotherapyIntensity Modulated Radiation Therapy With Simultaneous Integrated Boost | Device | RT groups |
Primary outcome
OS
Time frame: Duration of time from the start of therapy 3 years or until time of death, whichever occurs first
overall survival
3 secondary outcomes
iPFS
Time frame: Duration of time from the start of therapy to the time of intracranial disease progression, assessed up to 3 years
MMSE scores
Time frame: up to 2 years
overall response rate
Time frame: Up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengming（spring） Kong, MD contact
Jian Zhu, MD principal investigator
Taizhou Hospital, Wenzhou Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Temozolomide capsules and radiotherapy in people with Non Small Cell Lung Cancer Metastatic, run by Taizhou Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haihua Yang, MD (13819639006, yhh93181@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: Duration of time from the start of therapy 3 years or until time of death, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.