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

Primary Purpose

Meningioma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radiotherapy 68 Gy(RBE)
Radiotherapy 72 Gy(RBE)
Radiotherapy 60 Gy(RBE)
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningioma focused on measuring brain tumors, proton radiotherapy, photon radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Grade II tumors (macroscopic)

    Grade III tumors (macroscopic)

    Grade II/III tumors (completely resected)

    Arm Description

    Radiotherapy 68 Gy(RBE)

    Radiotherapy 72 Gy(RBE)

    Radiotherapy 60 Gy(RBE)

    Outcomes

    Primary Outcome Measures

    progression-free survival

    Secondary Outcome Measures

    late toxicity
    CTC-AE 4.0
    acute toxicity
    CTC-AE 4.0
    overall survival
    patterns of recurrence using MRI
    quality of life by validated quality of life questionnaires
    EORTC-QLQ-C30, EORTC-QLQ-BN20

    Full Information

    First Posted
    October 19, 2016
    Last Updated
    August 2, 2022
    Sponsor
    Technische Universität Dresden
    Collaborators
    German Cancer Research Center, Radiation Oncology Working Group of the German Cancer Society
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02978677
    Brief Title
    Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas
    Acronym
    PANAMA
    Official Title
    Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    December 2028 (Anticipated)
    Study Completion Date
    December 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Technische Universität Dresden
    Collaborators
    German Cancer Research Center, Radiation Oncology Working Group of the German Cancer Society

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Meningioma
    Keywords
    brain tumors, proton radiotherapy, photon radiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Grade II tumors (macroscopic)
    Arm Type
    Experimental
    Arm Description
    Radiotherapy 68 Gy(RBE)
    Arm Title
    Grade III tumors (macroscopic)
    Arm Type
    Experimental
    Arm Description
    Radiotherapy 72 Gy(RBE)
    Arm Title
    Grade II/III tumors (completely resected)
    Arm Type
    Active Comparator
    Arm Description
    Radiotherapy 60 Gy(RBE)
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiotherapy 68 Gy(RBE)
    Intervention Description
    Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiotherapy 72 Gy(RBE)
    Intervention Description
    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
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiotherapy 60 Gy(RBE)
    Intervention Description
    Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton
    Primary Outcome Measure Information:
    Title
    progression-free survival
    Time Frame
    5 years after start of radiotherapy
    Secondary Outcome Measure Information:
    Title
    late toxicity
    Description
    CTC-AE 4.0
    Time Frame
    5 years after start of radiotherapy
    Title
    acute toxicity
    Description
    CTC-AE 4.0
    Time Frame
    5 years after start of radiotherapy
    Title
    overall survival
    Time Frame
    5 years after start of radiotherapy
    Title
    patterns of recurrence using MRI
    Time Frame
    5 years after start of radiotherapy
    Title
    quality of life by validated quality of life questionnaires
    Description
    EORTC-QLQ-C30, EORTC-QLQ-BN20
    Time Frame
    5 years after start of radiotherapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mechthild Krause, Prof.
    Phone
    +49 351 458 5441
    Email
    mechthild.krause@uniklinikum-dresden.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mechthild Krause, Prof.
    Organizational Affiliation
    Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas

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