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Carbon Ion Radiotherapy for Recurrent Gliomas (CINDERELLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01166308
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : May 17, 2018
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Brief Summary:

Treatment of patients with recurrent glioma includes neurosurgical resection, chemotherapy, or radiation therapy. In most cases, a full course of radiotherapy has been applied after primary diagnosis, therefore application of re-irradiation has to be applied cautiously. With modern precision photon techniques such as fractionated stereotactic radiotherapy (FSRT), a second course of radiotherapy is safe and effective and leads to survival times of 22, 16 and 8 months for recurrent WHO grade II, III and IV tumors.

Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the Glioblastoma (GBM) cell line as well as the endpoint analyzed. Protons, however, offer an RBE which is comparable to photons.

First Japanese Data on the evaluation of carbon ion radiation therapy for the treatment of primary high-grade gliomas showed promising results in a small and heterogeneous patient collective.

In the current Phase I/II-CINDERELLA-trial re-irradiation using carbon ions will be compared to FSRT applied to the area of contrast enhancement representing high-grade tumor areas in patients with recurrent gliomas. Within the Phase I Part of the trial, the Recommended Dose (RD) of carbon ion radiotherapy will be determined in a dose escalation scheme. In the subsequent randomized Phase II part, the RD will be evaluated in the experimental arm, compared to the standard arm, FSRT with a total dose of 36 Gy in single doses of 2 Gy.

Primary endpoint of the Phase I part is toxicity. Primary endpoint of the randomized part II is survival after re-irradiation at 12 months, secondary endpoint is progression-free survival.

Condition or disease Intervention/treatment Phase
Glioma Radiation: Carbon Ion Radiotherapy Radiation: Fractionated Stereotactic Radiotherapy (FSRT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Phase I/II Study to Evaluate Carbon Ion Radiotherapy Versus Fractionated Stereotactic Radiotherapy in Patients With Recurrent or Progressive Gliomas: The CINDERELLA Trial
Actual Study Start Date : December 2010
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Carbon Ion Radiotherapy
Carbon Ion Radiotherapy in the RD determined within the Phase I Part of the Trial
Radiation: Carbon Ion Radiotherapy
Carbon Ion Radiotherapy in the RD determined within the Phase I part of the Study (10 x 3Gy E to 16 x 3 Gy E)

Active Comparator: Standard Treatment: Fractionated Stereotacitc Radiotherapy
Standard Precision Radiotherapy performed as Fractionated Stereotactic Radiotherapy (FSRT) up to 36 Gy in single dosis of 2 Gy
Radiation: Fractionated Stereotactic Radiotherapy (FSRT)
Standard Treatment as Re-Irradiation performed as Fractionated Stereotactic Radiotherapy (FSRT)up to 36 Gy in single doses of 2 Gy

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: at 12 months ]

Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: at 12 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • unifocal, supratentorial recurrent glioma
  • contrast enhancement on T1-weighted MRI and/or Amino-Acid-PET-positive high-grade tumor areas
  • indication re-irradiation
  • age ≥ 18 years of age
  • Karnofsky Performance Score ≥60
  • 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:

  • Multifocal Glioma or Gliomatosis cerebri
  • refusal of the patients to take part in the study
  • previous re-irradiation or prior radiosurgery or prio treatment with interstitial radioactive seeds
  • time interval of < 6 months after primary radiotherapy
  • 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.

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 identifier (NCT number): NCT01166308

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University Hospital of Heidelberg, Department of Radiation Oncology
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Juergen Debus, Prof. Dr. Dr. Jürgen Debus, University Hospital Heidelberg Identifier: NCT01166308    
Other Study ID Numbers: CINDERELLA
2009-017352-26 ( EudraCT Number )
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Keywords provided by Juergen Debus, University Hospital Heidelberg:
Recurrent Glioma
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue