Randomised Phase I/II Study to Evaluate Carbon Ion Radiotherapy Versus Fractionated Stereotactic Radiotherapy in Patients With Recurrent or Progressive Gliomas: The CINDERELLA Trial
Inclusion Criteria:
- unifocal, supratentorial recurrent glioma
- contrast enhancement on T1-weighted MRI and/or Amino-Acid-PET-positive high-grade
tumor areas
- indication re-irradiation
- age ≥ 18 years of age
- Karnofsky Performance Score ≥60
- For women with childbearing potential, (and men) 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:
- Multifocal Glioma or Gliomatosis cerebri
- refusal of the patients to take part in the study
- previous re-irradiation or prior radiosurgery or prio treatment with interstitial
radioactive seeds
- time interval of < 6 months after primary radiotherapy
- Patients who have not yet recovered from acute toxicities of prior therapies
- 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.