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Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas (PANAMA)

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ClinicalTrials.gov Identifier: NCT02978677
Recruitment Status : Not yet recruiting
First Posted : December 1, 2016
Last Update Posted : June 20, 2017
Sponsor:
Collaborators:
German Cancer Consortium (DKTK)
Radiation Oncology Working Group of the German Cancer Society
Information provided by (Responsible Party):
Mechthild Krause, Technische Universität Dresden

Brief 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.

Condition or disease Intervention/treatment Phase
Meningioma Radiation: Radiotherapy 68 Gy(RBE) Radiation: Radiotherapy 72 Gy(RBE) Radiation: Radiotherapy 60 Gy(RBE) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Grade II tumors (macroscopic)
Radiotherapy 68 Gy(RBE)
Radiation: Radiotherapy 68 Gy(RBE)
Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton

Experimental: Grade III tumors (macroscopic)
Radiotherapy 72 Gy(RBE)
Radiation: 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

Active Comparator: Grade II/III tumors (completely resected)
Radiotherapy 60 Gy(RBE)
Radiation: Radiotherapy 60 Gy(RBE)
Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 5 years after start of radiotherapy ]

Secondary Outcome Measures :
  1. late toxicity [ Time Frame: 5 years after start of radiotherapy ]
    CTC-AE 4.0

  2. acute toxicity [ Time Frame: 5 years after start of radiotherapy ]
    CTC-AE 4.0

  3. overall survival [ Time Frame: 5 years after start of radiotherapy ]
  4. patterns of recurrence using MRI [ Time Frame: 5 years after start of radiotherapy ]
  5. quality of life by validated quality of life questionnaires [ Time Frame: 5 years after start of radiotherapy ]
    EORTC-QLQ-C30, EORTC-QLQ-BN20



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978677


Contacts
Contact: Mechthild Krause, Prof. +49 351 458 5441 mechthild.krause@uniklinikum-dresden.de

Sponsors and Collaborators
Technische Universität Dresden
German Cancer Consortium (DKTK)
Radiation Oncology Working Group of the German Cancer Society
Investigators
Study Chair: Mechthild Krause, Prof. Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf

Responsible Party: Mechthild Krause, Principal Investigator, Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02978677     History of Changes
Other Study ID Numbers: STR-PANAMA-2015
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mechthild Krause, Technische Universität Dresden:
brain tumors
proton radiotherapy
photon radiotherapy

Additional relevant MeSH terms:
Meningioma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases