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Carbon Ion Radiotherapy for Recurrent Gliomas (CINDERELLA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by University Hospital Heidelberg.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Stephanie Combs, University Hospital Heidelberg Identifier:
First received: July 19, 2010
Last updated: February 18, 2013
Last verified: February 2013

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 Intervention Phase
Radiation: Carbon Ion Radiotherapy
Radiation: Fractionated Stereotactic Radiotherapy (FSRT)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University Hospital Heidelberg:

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

Secondary Outcome Measures:
  • Progression-free Survival

Estimated Enrollment: 436
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01166308

Contact: Stephanie E Combs, MD +49-6221-56 ext 8202
Contact: Jürgen Debus, MD PhD +49-6221-56 ext 8201

University Hospital of Heidelberg, Department of Radiation Oncology Recruiting
Heidelberg, Germany, 69120
Sub-Investigator: Stephanie E Combs, MD         
Principal Investigator: Jürgen Debus, MD PhD         
Sponsors and Collaborators
University Hospital Heidelberg
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stephanie Combs, Leitende Oberärtzin, University Hospital Heidelberg Identifier: NCT01166308     History of Changes
Other Study ID Numbers: CINDERELLA
2009-017352-26 ( EudraCT Number )
Study First Received: July 19, 2010
Last Updated: February 18, 2013

Keywords provided by University Hospital Heidelberg:
Recurrent Glioma

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue processed this record on April 28, 2017