Status:
COMPLETED
Carbon Ion Radiotherapy for Primary Glioblastoma
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Primary Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Treatment standard for patients with primary glioblastoma (GBM) is combined radiochemotherapy with temozolomide (TMZ). Radiation is delivered up to a total dose of 60 Gy using photons. Using this trea...
Detailed Description
Study design The purpose of the trial is to compare a carbon ion boost to a proton boost delivered to the macroscopic tumor in combination with combined radiochemotherapy with TMZ in patients with pr...
Eligibility Criteria
Inclusion
- histologically confirmed unifocal, supratentorial primary glioblastoma
- macroscopic tumor after biopsy or subtotal resection
- indication for combined radiochemotherapy with temozolomide
- prior photon irradiation of 48-52 Gy to the T2-hyperintense area, resection cavity, areas of contrast enhancement adding 2-3cm safety margin in combination with standard temozolomide
- registration prior to photon RT or within photon RT allowing the beginning of particle therapy ≤ 4 days after completion of photon irradiation
- beginning of study treatment (proton or carbon ion RT) no later than 12 weeks after primary diagnosis
- age ≥ 18 years
- Karnofsky Performance Score ≥ 60
- adequate contraception.
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Exclusion
- refusal of the patients to take part in the study
- previous radiotherapy of the brain or chemotherapy with DTIC or TMZ other than during the radiochemotherapy stated in the inclusion criteria
- more than 52 Gy applied via photon-RT prior to particle therapy
- time interval of \> 12 weeks after primary diagnosis (neurosurgical intervention) and beginning of study treatment (proton or carbon ion RT)
- Patients who have not yet recovered from acute toxicities of prior therapies
- Clinically active kidney, liver or cardiac disease
- Known carcinoma \< 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
- Pregnant or lactating women
- Participation in another clinical study or observation period of competing trials, respectively.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01165671
Start Date
July 1 2010
End Date
January 1 2015
Last Update
April 3 2020
Active Locations (1)
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1
University Hospital of Heidelberg, Department of Radiation Oncology
Heidelberg, Germany, 69120