Condition category
Cancer
Date applied
10/07/2010
Date assigned
07/02/2011
Last edited
07/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.uni-heidelberg.de

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

Publication citations

Additional files

Editorial Notes