Meningeal CarcinomatosisPhase 4NCT02590510
Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis
A Phase 4 study testing methotrexate in people with Meningeal Carcinomatosis, run by Hui Bu.
Trial summary
The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in the treatment of meningeal carcinomatosis. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Meningeal Carcinomatosis
- What is being tested?
- methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2017
- Phase
- Phase 4
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 14 or more
- a history of solid tumor
- a new clinical neurological signs and symptoms
- a typical CT(Computerized Tomography,CT) or MRI(Magnetic Resonance Imaging,MRI) imaging findings
- tumor cells in cerebrospinal fluid
Who cannot join
- KPS score <60
- the tumor patients with organ failure
- bacteria, fungi or viral meningitis
Trial locations and contacts
No sites are listed yet.
About this study
The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in the treatment of meningeal carcinomatosis.
- Conditions
- Meningeal Carcinomatosis
- Being tested
- methotrexate
- Keywords
- Intrathecal chemotherapy
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methotrexateDrug
Also called Intrathecal chemotherapy
The quantity of methotrexate is different in the two groups.
| Study group | Role | What they receive |
|---|---|---|
| The small dose of group | Experimental | The dose of methotrexate is 10 mg Receives: Drug: methotrexate |
| The high dose of group | Active comparator | The dose of methotrexate is 15 mg Receives: Drug: methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: one year
Secondary outcomes (2)
The incidence of adverse reactions
In accordance with the standard of CTCAE, an assessment will be assessed every month
Measured: one year
KPS score
In accordance with the standard of KPS(Karnofsky Performance Status,KPS) score, an assessment will be assessed every month
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningeal CarcinomatosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hui Bu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui Bu, Hebei Medical University
- Investigators
- Hui, Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590510
- Sponsor's protocol ID
- BH 001
- Status last verified
- Oct 2016
- First submitted
- 26 Oct 2015
- Last updated
- 28 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis
- ClinicalTrials.gov ID
- NCT02590510
- Acronym / sponsor ID
- BH 001
- Conditions
- Meningeal Carcinomatosis
- Keywords
- Intrathecal chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hui BuUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- 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.
The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in the treatment of meningeal carcinomatosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The small dose of group | Experimental | Drug: methotrexateThe dose of methotrexate is 10 mg |
| The high dose of group | Active comparator | Drug: methotrexateThe dose of methotrexate is 15 mg |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- age 14 or more
- a history of solid tumor
- a new clinical neurological signs and symptoms
- a typical CT(Computerized Tomography,CT) or MRI(Magnetic Resonance Imaging,MRI) imaging findings
- tumor cells in cerebrospinal fluid
Key exclusion criteria (3 listed)
- KPS score <60
- the tumor patients with organ failure
- bacteria, fungi or viral meningitis
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 |
|---|---|---|
| methotrexateAlso: Intrathecal chemotherapyThe quantity of methotrexate is different in the two groups. | Drug | The high dose of group, The small dose of group |
Primary outcome
overall survival
Time frame: one year
2 secondary outcomes
The incidence of adverse reactions
Time frame: one year
KPS score
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
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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.
Hui principal investigator
The Second Hospital of Hebei Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methotrexate in people with Meningeal Carcinomatosis, run by Hui Bu.
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 5 inclusion and 3 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 28 Oct 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Hui Bu (86-13831106903, buhuimy1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: one year). 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 28 Oct 2016.