Contact information
Type
Scientific
Primary contact
Prof Jürgen Debus
ORCID ID
Contact details
University Hospital of Heidelberg
Department of Radiation Oncology
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
+49 (0)6221 56 8201
juergen.debus@med.uni-heidelberg.de
Additional identifiers
EudraCT number
2009-017352-26
ClinicalTrials.gov number
Protocol/serial number
EudraCT No.: 2009-017352-26
Study information
Scientific title
Randomised phase I/II study to evaluate carbon ion radiotherapy versus fractionated stereotactic radiotherapy in patients with recurrent or progressive gliomas
Acronym
CINDERELLA
Study hypothesis
Phase I:
Phase I part of this study is conducted to choose the recommended dose (RD) of carbon ion radiotherapy for the phase II part between seven dose levels based on the dose escalation scheme.
Phase II:
The phase II part of this study is designed to demonstrate superiority in survival of carbon ion radiotherapy (experimental) to fractionated stereotactic radiotherapy (FSRT - standard) in patients with recurrent or progressive gliomas. The primary endpoints variable is overall survival time after at least 12 months of follow-up defined as time to death for any reason during the follow-up period of at least 12 months starting from date of randomisation.
Ethics approval
Local medical ethics committee (Ethikkommission der Medizinischen Fakultät Heidelberg) approved on the 21st January 2010 (ref: S442-2009)
Study design
Randomised phase I/II controlled non-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Recurrent glioma
Intervention
Phase I: Dose Escalation -
Patients fulfilling the inclusion criteria will be treated with increasing total dose of carbon ion radiotherapy to evaluate the optimal carbon ion dose with respect to toxicity. The aim of this part is to determine the recommended dose (RD) of carbon ion radiotherapy for re-irradiation of recurrent gliomas.
Patients will be treated within seven increasing dose regimens starting at 10 x 3 GyE up to 16 x 3 GyE.
Phase II: Randomised Part -
Patients fulfilling the inclusion criteria will be randomised into two arms:
Arm A (Experimental Arm): Carbon Ion Radiation Therapy - total dose applied will be the RD determined in the Phase I part of the study protocol
Arm B (Standard Arm): Fractionated Stereotactic Radiotherapy with Photons - total Dose 36 Gy, 18 fractions, 2 Gy single dose
Duration of the treatment:
Control arm: 18 treatment days (standard photon precision radiotherapy 36 Gy, 2 Gy single dose)
Experimental Arm: 10 to 16 treatment days, depending on MTD determined within the phase I part of the study
Follow-up: 12 months after study treatment
Intervention type
Other
Phase
Phase I/II
Drug names
Primary outcome measures
1. Phase I: Any Grade IV toxicity related to the study treatment according to Common Toxicity Criteria for Adverse Events (CTCAE) Grade IV
2. Phase II: Survival after re-irradiation at 12 months
Secondary outcome measures
1. Phase I: Survival after re-irradiation
2. Phase II:
2.1. Progression-free survival at 12 months
2.2. Toxicity
2.3. Safety
Overall trial start date
01/09/2010
Overall trial end date
31/08/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Unifocal, supratentorial recurrent glioma
2. Contrast enhancement on T1-weighted magnetic resonance imaging (MRI) and/or amino acid positron emission tomography (PET)-positive high-grade tumour areas
3. Indication re-irradiation
4. Aged greater than or equal to 18 years of age, either sex
5. Karnofsky Performance Score greater than or equal to 60
6. For women with childbearing potential, (and men) adequate contraception
7. Ability of subject to understand character and individual consequences of the clinical trial
8. Written informed consent (must be available before enrolment in the trial)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
436
Participant exclusion criteria
1. Multifocal glioma or gliomatosis cerebri
2. Refusal of the patients to take part in the study
3. Previous re-irradiation or prior radiosurgery or prior treatment with interstitial radioactive seeds
4. Time interval of less than 6 months after primary radiotherapy
5. Patients who have not yet recovered from acute toxicities of prior therapies
6. Known carcinoma less than 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
7. Pregnant or lactating women
8. Participation in another clinical study or observation period of competing trials, respectively
Recruitment start date
01/09/2010
Recruitment end date
31/08/2014
Locations
Countries of recruitment
Germany
Trial participating centre
University Hospital of Heidelberg
Heidelberg
69120
Germany
Sponsor information
Organisation
University Hospital of Heidelberg (Germany)
Sponsor details
c/o Irmtraud Gürkan
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
+49 (0)6221 56 7002
irmtraud.guerkan@med.uni-heidelberg.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital of Heidelberg (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary