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Randomized Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.

This study is not yet open for participant recruitment.
Verified February 2013 by University Hospital Heidelberg
Sponsor:
Information provided by (Responsible Party):
Stephanie Combs, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01795300
First received: February 18, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

In PINOCCHIO-Triayl, carbon ion radiotherapy is compared to proton and advanced photon radiotherapy in patients with skull base meningiomas. There will be two treatment arms with photons, one arm with hypofractionated photon radiotherapy, and one arm with conventional fractionation. The study is designed as descriptive study on feasibility of the investigated therapies aiming at a comparison of toxicities. The study will serve as a basis for further larger randomized protocols comparing efficacy of the therapies, assuming toxicity is comparable in all four treatment arms. Primary endpoint is toxicity, secondary endpoints are overall survival, progression-free survival and quality of life.


Condition Intervention Phase
Skull Base Meningioma
 Radiation: Carbon Ion Radiotherapy
Radiation: Proton Therapy
Radiation: Hypofractionated Photon Radiotherapy
Radiation: Conventional Photon Radiotherapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.

Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Toxicity graded according to CTCAE Version 4.1 after 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Toxicity graded according to CTCAE Version 4.1 after 1 year


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Overall survival

  • Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Progression-free survival

  • Quality of Life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carbon Ion Radiotherapy
Treatment Schedule Carbon Ion Radiation Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose
 Radiation: Carbon Ion Radiotherapy

Patients will be immobilized using an individually manufactured head mask for treatment planning and RT. Contrast-enhanced CT as well as MR-imaging will be performed for target volume definition. OAR such as the brain stem, optic nerves, chiasm and spinal chord will be contoured. The fractionation scheme will be taken into account for dose prescription, as well as DVH-characteristics and clinical parameters of the invidivual patient.

The Gross Tumor Volume (GTV) will be defined as the contrast-enhancing lesion on MRI on T1-weighted MR-imaging. Amino-Acid-PET or DOTATOC-PET may be used in addition to contrast-enhanced MRI for target volume definition but is not mandatory.The Clinical Target Volume (CTV) will be defined adding 1-2mm safety margin to the GTV.
Experimental: Proton Therapy
Treatment Schedule Proton Radiation Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose
 Radiation: Proton Therapy

As described previously, patients will be immobilized using an individually manufactured head mask for treatment planning and RT. Contrast-enhanced CT as well as MR-imaging will be performed for target volume definition. OAR such as the brain stem, optic nerves, chiasm and spinal chord will be contoured. Dose constraints of normal tissue will be respected according to Emami et al. (33). The fractionation scheme will be taken into account for dose prescription, as well as DVH-characteristics and clinical parameters of the invidivual patient.

The Gross Tumor Volume (GTV) will be defined as the contrast-enhancing lesion on MRI on T1-weighted MR-imaging. Amino-Acid-PET or DOTATOC-PET may be used in addition to contrast-enhanced MRI for target volume definition but is not mandatory.The Clinical Target Volume (CTV) will be defined adding 1-2mm safety margin to the GTV.
Experimental: Hypofractionated Photon Therapy
Treatment Schedule Photon Radiation 3 Gy E Total Dose 45 Gy E, 15 fractions, 3 Gy E single dose
 Radiation: Hypofractionated Photon Radiotherapy

Treatment Planning for Photon Radiotherapy will be performed using the Planning Systems available at the Department of Radiation Oncology in Heidelberg, Germany (including Masterplan/Nucletron, Virtuos-Konrad/Siemens, or Precisis/STP/Stryker-Leibinger, or the Tomotherapy Software). Carbon ion and proton RT planning is performed using the treatment planning software PT-Planning (Siemens, Erlangen, Germany) including biologic plan optimization. Biologically effective dose distributions will be calculated using the a/ß ratio for meningioma as well as for the endpoint late toxicity to the brain. Patient positioning prior to radiotherapy will be evaluated by comparison of x-rays to the DRRs. Set up deviations >3mm are corrected prior to radiotherapy.

To the target volume defined for photon treatment, a total dose of 52.2 Gy E - 57.6 Gy E is applied in single fractions of 1.8Gy E. In the 3Gy E Photon arm, photon radiotherapy will be delivered to a total dose of 45 Gy E in 15 fractions.
Active Comparator: Conventional Photon Radiotherapy
Treatment Schedule Photon Radiation 1.8 Gy E Total Dose 57.6 Gy Gy E, 32 fractions, 1.8 Gy E single dose
 Radiation: Conventional Photon Radiotherapy
Treatment Planning for Photon Radiotherapy will be performed using the Planning Systems available at the Department of Radiation Oncology in Heidelberg, Germany (including Masterplan/Nucletron, Virtuos-Konrad/Siemens, or Precisis/STP/Stryker-Leibinger, or the Tomotherapy Software). Carbon ion and proton RT planning is performed using the treatment planning software PT-Planning (Siemens, Erlangen, Germany) including biologic plan optimization. Biologically effective dose distributions will be calculated using the a/ß ratio for meningioma as well as for the endpoint late toxicity to the brain. Patient positioning prior to radiotherapy will be evaluated by comparison of x-rays to the DRRs. Set up deviations >3mm are corrected prior to radiotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients meeting all of the following criteria will be considered for admission to the trial:

  • Histologically or imaging confirmed skull base meningioma
  • macroscopic tumor - Simpson Grade 4 or 5
  • age ≥ 18 years of age
  • Karnofsky Performance Score >=60
  • For women with childbearing potential, (and men) adequate contraception (sexual abstinence, estrogen- or gestagen containing contraceptive medication etc.)
  • Female participants: No pregnancy present (pregnancy test required)
  • 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:

Patients presenting with any of the following criteria will not be included in the trial:

  • refusal of the patients to take part in the study
  • previous radiotherapy of the brain
  • histologically confirmed atypical or anaplastic meningioma
  • optic nerve sheath meningioma (ONSM)
  • Patients who have not yet recovered from acute toxicities of prior therapies
  • Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
  • Pregnant or lactating women
  • Participation in another clinical study or observation period of competing trials, respectively.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01795300

Locations
Germany
University Hospital of Heidelberg, Radiation Oncology Not yet recruiting
Heidelberg, Germany, 69120
Contact: Stephanie E Combs, Prof. Dr.     +49-6221-56 ext 8202     stephanie.combs@med.uni-heidelberg.de    
Contact: Renate Haselmann     +49-6221-56 ext 8202     renate.haselmann@med.uni-heidelberg.de    
Sponsors and Collaborators
University Hospital Heidelberg
  More Information

No publications provided

Responsible Party: Stephanie Combs, Prof. Dr. Stephanie E. Combs, Leitende Oberärztin, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01795300     History of Changes
Other Study ID Numbers: PINOCCHIO
Study First Received: February 18, 2013
Last Updated: February 18, 2013
Health Authority: Germany: Ethics Commission
Germany: Bundesamt für Strahlenschutz (BfS)

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

ClinicalTrials.gov processed this record on May 22, 2013