Carbon Ion Radiotherapy for Recurrent Gliomas (CINDERELLA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital Heidelberg
Sponsor:
Information provided by (Responsible Party):
Stephanie Combs, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01166308
First received: July 19, 2010
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival [ Designated as safety issue: No ]

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166308

Contacts
Contact: Stephanie E Combs, MD +49-6221-56 ext 8202 stephanie.combs@med.uni-heidelberg.de
Contact: Jürgen Debus, MD PhD +49-6221-56 ext 8201 juergen.debus@med.uni-heidelberg.de

Locations
Germany
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

No publications provided by University Hospital Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephanie Combs, Leitende Oberärtzin, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01166308     History of Changes
Other Study ID Numbers: CINDERELLA, 2009-017352-26
Study First Received: July 19, 2010
Last Updated: February 18, 2013
Health Authority: Germany: Federal Office for Radiation Protection

Keywords provided by University Hospital Heidelberg:
Recurrent Glioma

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 22, 2014