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
Scientific
University Hospital of Heidelberg
Department of Radiation Oncology
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 8201 |
|---|---|
| juergen.debus@med.uni-heidelberg.de |
Study information
| Study design | Randomised phase I/II controlled non-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised phase I/II study to evaluate carbon ion radiotherapy versus fractionated stereotactic radiotherapy in patients with recurrent or progressive gliomas |
| Study acronym | CINDERELLA |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2010 |
| Completion date | 31/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 436 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 31/08/2014 |
Locations
Countries of recruitment
- Germany
Study participating centre
University Hospital of Heidelberg
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University Hospital of Heidelberg (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o Irmtraud Gürkan
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 7002 |
|---|---|
| irmtraud.guerkan@med.uni-heidelberg.de | |
| Website | http://www.uni-heidelberg.de |
"ROR" |
https://ror.org/013czdx64 |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
