Condition category
Cancer
Date applied
19/07/2009
Date assigned
08/07/2010
Last edited
29/11/2011
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 Dr. Jürgen Debus

ORCID ID

Contact details

Department of Radiation Oncology
University Hospital of Heidelberg
Im Neuenheimer Feld 400
Heidelberg
69120
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01165671

Protocol/serial number

CLEOPATRA

Study information

Scientific title

Randomised phase II study evaluating a carbon ion boost applied after combined radiochemotherapy with temozolomide versus a proton boost after radiochemotherapy with temozolomide in patients with primary glioblastoma

Acronym

CLEOPATRA

Study hypothesis

The purpose of the trial is to compare a carbon ion boost to a proton boost delivered to the macroscopic tumour after combined radiochemotherapy (RT) with temozolomide (TMZ) in patients with primary glioblastoma multiforme (GBM). The aim of the study is to compare overall survival as a primary endpoint, and progression free survival, toxicity and safety as secondary endpoints.

Ethics approval

Ethics Committee of the Medical Faculty of Heidelberg (Ethikkommission der Medizinischen Fakultät Heidelberg) approved on the 2nd of November 2009

Study design

Randomised controlled phase II study

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

Primary glioblastoma

Intervention

Arm A – Experimental Arm
Carbon Ion Radiation Therapy as a Boost to the macroscopic tumour
Total Dose 18 Gy E, 6 fractions, 3 Gy E single dose

Arm B – Standard Arm
Proton Radiation Therapy as a Boost to the macroscopic tumour
Total Dose 10 Gy E, 5 fractions, 2 Gy E single dose

In both treatment arms, the minimum follow-up will be 12 months after study treatment (for the last patient included). All other patients will be followed until 12 months after the last patient was included or until death.

Intervention type

Drug

Phase

Phase II

Drug names

Temozolomide

Primary outcome measures

Overall survival during the follow-up phase of at least 12 months (starting with initial diagnosis)

Secondary outcome measures

1. Progression-free survival
2. Safety
3. Toxicity

Overall trial start date

01/11/2009

Overall trial end date

31/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed unifocal, supratentorial primary glioblastoma
2. Macroscopic tumour after biopsy or subtotal resection
3. Indication for combined radiochemotherapy with temozolomide
4. Prior photon irradiation of 50 Gy to the T2-hyperintense area, resection cavity, areas of contrast enhancement adding 2 - 3 cm safety margin
5. Registration prior to photon RT or within photon RT allowing the beginning of C12 greater than or equal to 4 days after completion of photon irradiation
6. Beginning of study treatment (proton or carbon ion RT) no later than 10 weeks after primary diagnosis
7. Aged greater than or equal to 18 years, either sex
8. Karnofsky Performance Score less than or equal to 60
9. Life expectancy greater than 12 weeks
10. For women with childbearing potential, (and men) adequate contraception
11. Ability of subject to understand character and individual consequences of the clinical trial
12. Written informed consent (must be available before enrolment in the trial)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Refusal of the patients to take part in the study
2. Previous radiotherapy of the brain or chemotherapy with dacarbazine (DTIC) or TMZ
3. More than 50.4 Gy applied via photon-RT prior to carbon ion RT
4. Time interval of greater than 10 weeks after primary diagnosis and beginning of study treatment (proton or carbon ion RT)
5. Patients who have not yet recovered from acute toxicities of prior therapies
6. Clinically active kidney-liver or cardiac disease
7. 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
8. Human immunodeficiency virus (HIV)
9. Pregnant or lactating women
10. Participation in another clinical study or observation period of competing trials, respectively

Recruitment start date

01/11/2009

Recruitment end date

31/10/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Radiation Oncology
Heidelberg
69120
Germany

Sponsor information

Organisation

University Hospital of Heidelberg (Germany)

Sponsor details

c/o Prof. Dr. Jürgen Debus
Department of Radiation Oncology
Im Neuenheimer Feld 400
Heidelberg
69120
Germany

Sponsor type

University/education

Website

http://www.uni-heidelberg.de/university/welcome/medics-hd.html

Funders

Funder type

Research council

Funder name

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) - Klinische Forschergruppe Schwerionentherapie (ref: KFO 214)

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20819220

Publication citations

  1. Results

    Combs SE, Kieser M, Rieken S, Habermehl D, Jäkel O, Haberer T, Nikoghosyan A, Haselmann R, Unterberg A, Wick W, Debus J, Randomized phase II study evaluating a carbon ion boost applied after combined radiochemotherapy with temozolomide versus a proton boost after radiochemotherapy with temozolomide in patients with primary glioblastoma: the CLEOPATRA trial., BMC Cancer, 2010, 10, 478, doi: 10.1186/1471-2407-10-478.

Additional files

Editorial Notes