Meningioma AtypicalNCT04127760
Efficacy of Postoperative Radiotherapy for Atypical Meningioma Without Venous Sinus Invasion After Gross-total Resection
A study testing radiotherapy in people with Meningioma Atypical and Radiotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Postoperative adjuvant radiotherapy is a key component of comprehensive treatment of meningioma. However, for atypical meningioma after total resection, there is still a huge controversy in patients who need adjuvant radiotherapy after surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Meningioma Atypical, Radiotherapy, Progression-Free Survival
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jan 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent gross total resection at each center and were diagnosed as atypical meningioma (WHO class II) according to the WHO 2016 diagnostic criteria.
- Gross total resection was defined as modified Simpson 1-3 and confirmed by postoperative magnetic resonance imaging.
Who cannot join
- age less than 18 years old or older than 70 years
- meningioma recurrence
- patients had previous radiotherapy
- multiple meningioma
- optic nerve sheath meningioma or other extracranial meningioma
- tumor involving venous sinus
Show all 12Show fewer
- ECOG score ≥ 2 points
- preoperative ASA grade ≥ 3
- previous or current malignant tumors
- pregnant or lactating women
- Patients with Gd-DTPA allergies, spatial claustrophobia or pacemaker implantation that can not be conducted constract-enhanced head magnetic resonance examination
- patients who were unable to obtain informed consent or refused to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Randomized Controlled Trial of the Efficacy of Postoperative Radiotherapy for Atypical Meningioma Without Venous Sinus Invasion After Gross-total Resection
Postoperative adjuvant radiotherapy is a key component of comprehensive treatment of meningioma. However, for atypical meningioma after total resection, there is still a huge controversy in patients who need adjuvant radiotherapy after surgery.
Many scholars have focused on this problem and carried out some small-scale retrospective studies, but they have contradictory results. Some of the studies found that postoperative adjuvant radiotherapy could not improve the prognosis of patients, but was questioned because the sample size was too small, resulting in insignificant results, while other studies found that postoperative adjuvant radiotherapy can improve progression free survival. A study based on the National Cancer Database found that postoperative adjuvant radiotherapy and gross tumor resection are associated with a good prognosis. A recent meta-analysis enrolled a total of 757 patients and found that postoperative adjuvant radiotherapy reduced the risk of tumor recurrence but did not improve survival time. Our team reviewed the meningioma data in the SEER database and conducted a study previously. The study found that postoperative adjuvant radiotherapy did not improve the overall survival of these patients. The relevant research results were recently published in Frontiers in oncology. We further reviewed and summarized the single-center data of our hospital and found that postoperative adjuvant radiotherapy could not improve the progression free survival and overall survival of patients. Besides, we also performed a meta-analysis and found that postoperative adjuvant radiotherapy had a trend to improve progression-free survival, but there was no statistical difference.
Because there are many deficiencies in previous researches, and the research results are also contradictory, it is still unclear whether patients with atypical meningioma who have undergone gross total resection can benefit from postoperative adjuvant radiotherapy. Further high quality clinical trials is still needed to be conducted in order to guide the postoperative care of patients. Therefore, we intend to conduct this multicenter randomized controlled trial to determine the value of postoperative adjuvant radiotherapy in patients with atypical meningioma who underwent gross total resection.
Read the detailed description
The study aims to enroll a total of 140 participants. Subjects would be enrolled with the following information: name, age, gender, contact, KPS score, preoperative ASA score, current ECOG score, tumor location, date of surgery, degree of tumor resection (modified Simpson grade), pathology type, Ki-67 Proliferation index, etc. The preoperative magnetic resonance image of the subject is stored. Tissue specimens are genetically examined.
Using a simple randomization method and random assignment in a 1:1 ratio, a random sequence was first generated, and SAS version 9.1 statistical software was used to generate an allocation sequence table including subject numbers, 140 random numbers, and random groupings. 140 Subjects would be assigned to the test group (n=70) and the control group (n=70) in a 1:1 ratio. The table of the assignment sequence is duplicated and saved by the neurosurgical secretary and the trial designer of the Second Affiliated Hospital of Zhejiang University. The secretary puts the group mark into the 140 opaque kraft envelopes with the serial number 1 to 140 according to the order of the allocation sequence table, and submits them to the test designer. Zhige Guo is responsible for enrolling the participants according to the inclusion criteria, assigning the subjects numbers according to the order of the treatment, and Qiang Zeng is responsible for disassembling the corresponding opaque envelopes according to the number of the subjects, and exerting interventions according to the group marks. Chenhan Ling is responsible for follow-up and regular measurement of various indicators, and Fei Dong is responsible for the images reports. Until the end of the trial, Zhige Guo, Chenhan Ling and Fei Dong would not know the grouping of the subjects.
The test level of the study was α=0.05, and the two-sided test was used. All statistical analysis was performed by SPSS 16.0 statistical software.
- For PFS, OS, and DSS data, the COX proportional hazards model was used to calculate the hazard ratio (HR) of radiotherapy and to assess the statistical difference between the corresponding prognostic data between the two groups.
- For the 3-year progression-free survival, 3-year survival rate, and 5-year progression-free survival, 5-year survival rate data, the chi-square test was used to compare the differences between the two groups.
- Conditions
- Meningioma Atypical, Radiotherapy, Progression-Free Survival, Adverse Effect of Radiation Therapy
- Being tested
- radiotherapy
- Keywords
- Meningioma Atypical, radiotherapy
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
Radiotherapy would start within 2 months after the operation, and 5 days of radiotherapy is performed every week. The dose of each radiotherapy is 1.8 Gy for 6 weeks, and the total dose is 54 Gy.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Follow-up at several time frames |
| treatment | Experimental | Radiotherapy would be carried out. Follow-up at the same time frames as the control arm Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
the length of time during and after medication or treatment during which the disease being treated does not get worse
Measured: 60months
Secondary outcomes (7)
3-year survival rate
the percentage of people in a study or treatment group still alive for 3 years after diagnosis
Measured: 36months
3-year progression-free survival
3 years during and after medication or treatment during which the disease being treated does not get worse
Measured: 36months
5-year survival rate
the percentage of people in a study or treatment group still alive for 5 years after diagnosis
Measured: 60months
10-year progression-free survival
10 years during and after medication or treatment during which the disease being treated does not get worse
Measured: 120 months
10-year survival rate
the percentage of people in a study or treatment group still alive for 10 years after diagnosis
Measured: 120 months
Disease-specific survival
the percentage of people in a study or treatment group who have not died from a specific disease in a defined period of time. The time period usually begins at the time of diagnosis or at the start of treatment and ends at the time of death. Patients who died from causes other than the disease being studied are not counted in this measurement
Measured: from diagnosis up to 10 years
overall survival
From randomization to death due to any cause
Measured: from diagnosis up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningioma AtypicalStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Zhejiang Provincial People's Hospital, Ningbo Medical Center Lihuili Hospital, Jinhua Central Hospital, Taizhou Hospital, Shaoxing Hospital of Zhejiang University, People's Hospital of Quzhou, Huzhou Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127760
- Sponsor's protocol ID
- ns20191111
- Status last verified
- Oct 2019
- First submitted
- 14 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of the Efficacy of Postoperative Radiotherapy for Atypical Meningioma Without Venous Sinus Invasion After Gross-total Resection
- ClinicalTrials.gov ID
- NCT04127760
- Acronym / sponsor ID
- ns20191111
- Conditions
- Meningioma Atypical, Radiotherapy, Progression-Free Survival, Adverse Effect of Radiation Therapy
- Keywords
- Meningioma Atypical, radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Zhejiang Provincial People's Hospital, Ningbo Medical Center Lihuili Hospital, Jinhua Central Hospital, Taizhou Hospital, Shaoxing Hospital of Zhejiang University, People's Hospital of Quzhou, Huzhou Central Hospital
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2033 (estimated)
- First posted
- 16 Oct 2019 (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.
Postoperative adjuvant radiotherapy is a key component of comprehensive treatment of meningioma. However, for atypical meningioma after total resection, there is still a huge controversy in patients who need adjuvant radiotherapy after surgery.
Many scholars have focused on this problem and carried out some small-scale retrospective studies, but they have contradictory results. Some of the studies found that postoperative adjuvant radiotherapy could not improve the prognosis of patients, but was questioned because the sample size was too small, resulting in insignificant results, while other studies found that postoperative adjuvant radiotherapy can improve progression free survival. A study based on the National Cancer Database found that postoperative adjuvant radiotherapy and gross tumor resection are associated with a good prognosis. A recent meta-analysis enrolled a total of 757 patients and found that postoperative adjuvant radiotherapy reduced the risk of tumor recurrence but did not improve survival time. Our team reviewed the meningioma data in the SEER database and conducted a study previously. The study found that postoperative adjuvant radiotherapy did not improve the overall survival of these patients. The relevant research results were recently published in Frontiers in oncology. We further reviewed and summarized the single-center data of our hospital and found that postoperative adjuvant radiotherapy could not improve the progression free survival and overall survival of patients. Besides, we also performed a meta-analysis and found that postoperative adjuvant radiotherapy had a trend to improve progression-free survival, but there was no statistical difference.
Because there are many deficiencies in previous researches, and the research results are also contradictory, it is still unclear whether patients with atypical meningioma who have undergone gross total resection can benefit from postoperative adjuvant radiotherapy. Further high quality clinical trials is still needed to be conducted in order to guide the postoperative care of patients. Therefore, we intend to conduct this multicenter randomized controlled trial to determine the value of postoperative adjuvant radiotherapy in patients with atypical meningioma who underwent gross total resection.
Detailed description
The study aims to enroll a total of 140 participants. Subjects would be enrolled with the following information: name, age, gender, contact, KPS score, preoperative ASA score, current ECOG score, tumor location, date of surgery, degree of tumor resection (modified Simpson grade), pathology type, Ki-67 Proliferation index, etc. The preoperative magnetic resonance image of the subject is stored. Tissue specimens are genetically examined.
Using a simple randomization method and random assignment in a 1:1 ratio, a random sequence was first generated, and SAS version 9.1 statistical software was used to generate an allocation sequence table including subject numbers, 140 random numbers, and random groupings. 140 Subjects would be assigned to the test group (n=70) and the control group (n=70) in a 1:1 ratio. The table of the assignment sequence is duplicated and saved by the neurosurgical secretary and the trial designer of the Second Affiliated Hospital of Zhejiang University. The secretary puts the group mark into the 140 opaque kraft envelopes with the serial number 1 to 140 according to the order of the allocation sequence table, and submits them to the test designer. Zhige Guo is responsible for enrolling the participants according to the inclusion criteria, assigning the subjects numbers according to the order of the treatment, and Qiang Zeng is responsible for disassembling the corresponding opaque envelopes according to the number of the subjects, and exerting interventions according to the group marks. Chenhan Ling is responsible for follow-up and regular measurement of various indicators, and Fei Dong is responsible for the images reports. Until the end of the trial, Zhige Guo, Chenhan Ling and Fei Dong would not know the grouping of the subjects.
The test level of the study was α=0.05, and the two-sided test was used. All statistical analysis was performed by SPSS 16.0 statistical software.
- For PFS, OS, and DSS data, the COX proportional hazards model was used to calculate the hazard ratio (HR) of radiotherapy and to assess the statistical difference between the corresponding prognostic data between the two groups.
- For the 3-year progression-free survival, 3-year survival rate, and 5-year progression-free survival, 5-year survival rate data, the chi-square test was used to compare the differences between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Follow-up at several time frames |
| treatment | Experimental | Radiation: radiotherapyRadiotherapy would be carried out. Follow-up at the same time frames as the control arm |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who underwent gross total resection at each center and were diagnosed as atypical meningioma (WHO class II) according to the WHO 2016 diagnostic criteria.
- Gross total resection was defined as modified Simpson 1-3 and confirmed by postoperative magnetic resonance imaging.
Key exclusion criteria (12 listed)
- age less than 18 years old or older than 70 years
- meningioma recurrence
- patients had previous radiotherapy
- multiple meningioma
- optic nerve sheath meningioma or other extracranial meningioma
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 |
|---|---|---|
| radiotherapyRadiotherapy would start within 2 months after the operation, and 5 days of radiotherapy is performed every week. The dose of each radiotherapy is 1.8 Gy for 6 weeks, and the total dose is 54 Gy. | Radiation | treatment |
Primary outcome
Progression-free survival
Time frame: 60months
the length of time during and after medication or treatment during which the disease being treated does not get worse
7 secondary outcomes
3-year survival rate
Time frame: 36months
3-year progression-free survival
Time frame: 36months
5-year survival rate
Time frame: 60months
10-year progression-free survival
Time frame: 120 months
10-year survival rate
Time frame: 120 months
Disease-specific survival
Time frame: from diagnosis up to 10 years
overall survival
Time frame: from diagnosis up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Meningioma Atypical
RecruitingPhase 2
A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
Meningioma
RecruitingPhase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Central Nervous System Neoplasms, Glioblastoma
RecruitingObservational study
Frequency and Clinical Phenotype of BAP1 Hereditary Predisposition Syndrome
Uveal Melanoma, Cutaneous Melanoma
Active, not recruitingPhase 2
An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent Meningioma
Meningiomas
Active, not recruiting
Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma
Brain Cancer
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.
Questions about this trial
What is this clinical trial studying?
A study testing radiotherapy in people with Meningioma Atypical and Radiotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 2 inclusion and 12 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: opening soon, as of the sponsor's last update on 16 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Zeng, MD (+86 0571 87784715, zengqiang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 60months). 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 16 Oct 2019.