Carbon ion radiotherapy versus fractionated stereotactic radiotherapy in patients with recurrent or progressive gliomas: the CINDERELLA trial

ISRCTN ISRCTN01460925
DOI https://doi.org/10.1186/ISRCTN01460925
EudraCT/CTIS number 2009-017352-26
Secondary identifying numbers EudraCT No.: 2009-017352-26
Submission date
10/07/2010
Registration date
07/02/2011
Last edited
07/02/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jürgen Debus
Scientific

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

Study information

Study designRandomised phase I/II controlled non-blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised phase I/II study to evaluate carbon ion radiotherapy versus fractionated stereotactic radiotherapy in patients with recurrent or progressive gliomas
Study acronymCINDERELLA
Study objectivesPhase 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(s)Local medical ethics committee (Ethikkommission der Medizinischen Fakultät Heidelberg) approved on the 21st January 2010 (ref: S442-2009)
Health condition(s) or problem(s) studiedRecurrent glioma
InterventionPhase 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 typeOther
Primary outcome measure1. 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 measures1. Phase I: Survival after re-irradiation
2. Phase II:
2.1. Progression-free survival at 12 months
2.2. Toxicity
2.3. Safety
Overall study start date01/09/2010
Completion date31/08/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target number of participants436
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/09/2010
Date of final enrolment31/08/2014

Locations

Countries of recruitment

  • Germany

Study participating centre

University Hospital of Heidelberg
Heidelberg
69120
Germany

Sponsor information

Funders

Funder type

Hospital/treatment centre

University Hospital of Heidelberg (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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