MeningiomaPANAMANCT02978677
Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas
A study testing Radiotherapy 68 Gy(RBE), Radiotherapy 72 Gy(RBE) and Radiotherapy 60 Gy(RBE) in people with Meningioma, run by Technische Universität Dresden.
Trial summary
The trial evaluates the effect of a moderately increased radiation dose in patients with atypical (grade II) and anaplastic (grade III) meningioma after incomplete or no surgery. Endpoint is recurrence-free survival after 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- Radiotherapy 68 Gy(RBE), Radiotherapy 72 Gy(RBE) and Radiotherapy 60 Gy(RBE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed atypical (WHO grade II) or anaplastic (WHO grade III) meningioma with the indication for radiotherapy
- MRI (within 24h post-operative, if not available than with a time interval of ~ 6 weeks) including contrast-enhanced T1 weighted 3D dataset and PET for evaluation of macroscopic tumour (residuum)
- Karnofsky Performance Score ≥ 60, ECOG ≤2
- For women with childbearing potential, (and men) adequate contraception.
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Who cannot join
- refusal of the patients to take part in the study
- previous radiotherapy of the brain
- several manifestations of the meningioma in different regions of the brain or additional spinal manifestations
- distant metastases
- patients who are not suitable for radiotherapy
- known other malignant disease within 5 years before radiotherapy (except tumours that likely do not impact prognosis and likely not require treatment interfering with study therapy, e.g. in-situ carcinoma of the breast or cervix uteri)
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- pregnant or lactating women
- patients with non-MRI compatible metal implants, pacemaker or non-MRI compatible external automatic defibrillators
- patients not able to understand character and individual consequences of the clinical trial
- claustrophobic patients
- current participation in another clinical intervention 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
The trial evaluates the effect of a moderately increased radiation dose in patients with atypical (grade II) and anaplastic (grade III) meningioma after incomplete or no surgery. Endpoint is recurrence-free survival after 5 years.
Read the detailed description
The trial intends to optimize treatment for grade II and grade III (atypical or anaplastic) meningioma. Standard treatment for atypical or anaplastic meningioma is surgery. For grade III (anaplastic) meningiomas, post-operative radiotherapy would be performed in all cases using standard fractionation schedules to a total dose of ~60 Gy. For grade II (atypical) meningiomas, although some small patient datasets support early onset of radiotherapy, the standard treatment is still to irradiate if tumours are recurrent or if resection was macroscopically incomplete. Total doses of 54 to ~60 Gy are applied using standard fractionation schedules.
A major problem of the treatment of atypical or anaplastic meningioma is that beyond surgery and radiotherapy, there are only experimental treatment options and the probability of local recurrences is 50-100% within the first 5 years for grade II and grade III meningioma.
The present trial has been developed to evaluate efficacy of a dose-intensified radiotherapy treatment schedule for incompletely or not resected meningioma to a total dose of 68 (grade II) or 72 Gy (grade III). To minimize normal tissue toxicity, the boost dose or the complete radiotherapy is applied using protons. The expectation is a higher recurrence-free survival compared to previous reports on outcome of standard dose (60 Gy) radiotherapy.
- Conditions
- Meningioma
- Being tested
- Radiotherapy 68 Gy(RBE), Radiotherapy 72 Gy(RBE), Radiotherapy 60 Gy(RBE)
- Keywords
- brain tumors, proton radiotherapy, photon radiotherapy
- Medical subject headings
- Meningioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy 68 Gy(RBE)Radiation
Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton
Radiotherapy 72 Gy(RBE)Radiation
Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton and boost 2 to 4 Gy(RBE) proton
Radiotherapy 60 Gy(RBE)Radiation
Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton
| Study group | Role | What they receive |
|---|---|---|
| Grade II tumors (macroscopic) | Experimental | Radiotherapy 68 Gy(RBE) Receives: Radiation: Radiotherapy 68 Gy(RBE) |
| Grade III tumors (macroscopic) | Experimental | Radiotherapy 72 Gy(RBE) Receives: Radiation: Radiotherapy 72 Gy(RBE) |
| Grade II/III tumors (completely resected) | Active comparator | Radiotherapy 60 Gy(RBE) Receives: Radiation: Radiotherapy 60 Gy(RBE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 5 years after start of radiotherapy
Secondary outcomes (5)
late toxicity
CTC-AE 4.0
Measured: 5 years after start of radiotherapy
acute toxicity
CTC-AE 4.0
Measured: 5 years after start of radiotherapy
overall survival
Measured: 5 years after start of radiotherapy
patterns of recurrence using MRI
Measured: 5 years after start of radiotherapy
quality of life by validated quality of life questionnaires
EORTC-QLQ-C30, EORTC-QLQ-BN20
Measured: 5 years after start of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startOct 2022 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center, Radiation Oncology Working Group of the German Cancer Society
- Responsible party
- Principal investigator, Mechthild Krause, Technische Universität Dresden
- Investigators
- Mechthild Krause, Prof., Study chair, Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978677
- Sponsor's protocol ID
- STR-PANAMA-2015
- Acronym
- PANAMA
- Status last verified
- Aug 2022
- First submitted
- 19 Oct 2016
- Last updated
- 3 Aug 2022
- 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 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas
- ClinicalTrials.gov ID
- NCT02978677
- Acronym / sponsor ID
- PANAMA / STR-PANAMA-2015
- Conditions
- Meningioma
- Keywords
- brain tumors, proton radiotherapy, photon radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Cancer Research Center, Radiation Oncology Working Group of the German Cancer Society
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 1 Dec 2016 (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 trial evaluates the effect of a moderately increased radiation dose in patients with atypical (grade II) and anaplastic (grade III) meningioma after incomplete or no surgery. Endpoint is recurrence-free survival after 5 years.
Detailed description
The trial intends to optimize treatment for grade II and grade III (atypical or anaplastic) meningioma. Standard treatment for atypical or anaplastic meningioma is surgery. For grade III (anaplastic) meningiomas, post-operative radiotherapy would be performed in all cases using standard fractionation schedules to a total dose of ~60 Gy. For grade II (atypical) meningiomas, although some small patient datasets support early onset of radiotherapy, the standard treatment is still to irradiate if tumours are recurrent or if resection was macroscopically incomplete. Total doses of 54 to ~60 Gy are applied using standard fractionation schedules.
A major problem of the treatment of atypical or anaplastic meningioma is that beyond surgery and radiotherapy, there are only experimental treatment options and the probability of local recurrences is 50-100% within the first 5 years for grade II and grade III meningioma.
The present trial has been developed to evaluate efficacy of a dose-intensified radiotherapy treatment schedule for incompletely or not resected meningioma to a total dose of 68 (grade II) or 72 Gy (grade III). To minimize normal tissue toxicity, the boost dose or the complete radiotherapy is applied using protons. The expectation is a higher recurrence-free survival compared to previous reports on outcome of standard dose (60 Gy) radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grade II tumors (macroscopic) | Experimental | Radiation: Radiotherapy 68 Gy(RBE)Radiotherapy 68 Gy(RBE) |
| Grade III tumors (macroscopic) | Experimental | Radiation: Radiotherapy 72 Gy(RBE)Radiotherapy 72 Gy(RBE) |
| Grade II/III tumors (completely resected) | Active comparator | Radiation: Radiotherapy 60 Gy(RBE)Radiotherapy 60 Gy(RBE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically confirmed atypical (WHO grade II) or anaplastic (WHO grade III) meningioma with the indication for radiotherapy
- MRI (within 24h post-operative, if not available than with a time interval of ~ 6 weeks) including contrast-enhanced T1 weighted 3D dataset and PET for evaluation of macroscopic tumour (residuum)
- Karnofsky Performance Score ≥ 60, ECOG ≤2
- For women with childbearing potential, (and men) adequate contraception.
- Ability of subject to understand character and individual consequences of the clinical trial
Key exclusion criteria (11 listed)
- refusal of the patients to take part in the study
- previous radiotherapy of the brain
- several manifestations of the meningioma in different regions of the brain or additional spinal manifestations
- distant metastases
- patients who are not suitable for radiotherapy
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 |
|---|---|---|
| Radiotherapy 68 Gy(RBE)Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton | Radiation | Grade II tumors (macroscopic) |
| Radiotherapy 72 Gy(RBE)Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton and boost 2 to 4 Gy(RBE) proton | Radiation | Grade III tumors (macroscopic) |
| Radiotherapy 60 Gy(RBE)Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton | Radiation | Grade II/III tumors (completely resected) |
Primary outcome
progression-free survival
Time frame: 5 years after start of radiotherapy
5 secondary outcomes
late toxicity
Time frame: 5 years after start of radiotherapy
acute toxicity
Time frame: 5 years after start of radiotherapy
overall survival
Time frame: 5 years after start of radiotherapy
patterns of recurrence using MRI
Time frame: 5 years after start of radiotherapy
quality of life by validated quality of life questionnaires
Time frame: 5 years after start of radiotherapy
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 3 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Mechthild Krause, Prof. study chair
Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy 68 Gy(RBE), Radiotherapy 72 Gy(RBE) and Radiotherapy 60 Gy(RBE) in people with Meningioma, run by Technische Universität Dresden.
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 6 inclusion and 11 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 3 Aug 2022. 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 Mechthild Krause, Prof. (+49 351 458 5441, mechthild.krause@uniklinikum-dresden.de), 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: 5 years after start of radiotherapy). 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 3 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.