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11 February 2012
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| [ Print-friendly version ] |
| Carbon ion boost versus proton boost after radiochemotherapy with temozolomide in patients with primary glioblastoma |
| ISRCTN | ISRCTN37428883 |
| ClinicalTrials.gov identifier | NCT01165671 |
| Public title | Carbon ion boost versus proton boost after radiochemotherapy with temozolomide in patients with primary glioblastoma |
| 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 |
| Serial number at source | 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. |
| Lay summary | Not provided at time of registration |
| 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 |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Primary glioblastoma |
| Participants - 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) |
| Participants - 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 |
| Anticipated start date | 01/11/2009 |
| Anticipated end date | 31/10/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 150 |
| Interventions |
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. |
| Primary outcome measure(s) | Overall survival during the follow-up phase of at least 12 months (starting with initial diagnosis) |
| Secondary outcome measure(s) |
1. Progression-free survival
2. Safety 3. Toxicity |
| Sources of funding | German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) - Klinische Forschergruppe Schwerionentherapie (ref: KFO 214) |
| Trial website | |
| Publications | 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20819220 |
| Contact name | Prof Dr. Jürgen Debus |
| Address |
Department of Radiation Oncology
University Hospital of Heidelberg Im Neuenheimer Feld 400 |
| City/town | Heidelberg |
| Zip/Postcode | 69120 |
| Country | Germany |
| Sponsor | University Hospital of Heidelberg (Germany) |
| Address |
c/o Prof. Dr. Jürgen Debus
Department of Radiation Oncology Im Neuenheimer Feld 400 |
| City/town | Heidelberg |
| Zip/Postcode | 69120 |
| Country | Germany |
| Sponsor website: | http://www.uni-heidelberg.de/university/welcome/medics-hd.html |
| Date applied | 19/07/2009 |
| Last edited | 29/11/2011 |
| Date ISRCTN assigned | 08/07/2010 |
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