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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 Research Center
Radiation Oncology Working Group of the German Cancer Society
Information provided by (Responsible Party):
Mechthild Krause, Technische Universität Dresden

October 19, 2016
December 1, 2016
June 20, 2017
January 2018
December 2027   (Final data collection date for primary outcome measure)
progression-free survival [ Time Frame: 5 years after start of radiotherapy ]
Same as current
Complete list of historical versions of study NCT02978677 on ClinicalTrials.gov Archive Site
  • late toxicity [ Time Frame: 5 years after start of radiotherapy ]
    CTC-AE 4.0
  • acute toxicity [ Time Frame: 5 years after start of radiotherapy ]
    CTC-AE 4.0
  • 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 ]
    EORTC-QLQ-C30, EORTC-QLQ-BN20
Same as current
Not Provided
Not Provided
 
Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas
Proton Dose Escalation for Patients With Atypical or Anaplastic Meningiomas
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.

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.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Meningioma
  • Radiation: Radiotherapy 68 Gy(RBE)
    Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton
  • 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
  • Radiation: Radiotherapy 60 Gy(RBE)
    Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton
  • Experimental: Grade II tumors (macroscopic)
    Radiotherapy 68 Gy(RBE)
    Intervention: Radiation: Radiotherapy 68 Gy(RBE)
  • Experimental: Grade III tumors (macroscopic)
    Radiotherapy 72 Gy(RBE)
    Intervention: Radiation: Radiotherapy 72 Gy(RBE)
  • Active Comparator: Grade II/III tumors (completely resected)
    Radiotherapy 60 Gy(RBE)
    Intervention: Radiation: Radiotherapy 60 Gy(RBE)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
90
Same as current
December 2028
December 2027   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Mechthild Krause, Prof. +49 351 458 5441 mechthild.krause@uniklinikum-dresden.de
Not Provided
 
 
NCT02978677
STR-PANAMA-2015
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Mechthild Krause, Technische Universität Dresden
Technische Universität Dresden
  • German Cancer Research Center
  • Radiation Oncology Working Group of the German Cancer Society
Study Chair: Mechthild Krause, Prof. Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf
Technische Universität Dresden
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP