Clinical Trial Details
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NCT01165671 : Carbon Ion Radiotherapy for Primary Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- 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

- 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 Criteria:

- 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,
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