ISRCTN01460925
Completed
Not Applicable
Randomised phase I/II study to evaluate carbon ion radiotherapy versus fractionated stereotactic radiotherapy in patients with recurrent or progressive gliomas
niversity Hospital of Heidelberg (Germany)0 sites436 target enrollmentFebruary 7, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recurrent glioma
- Sponsor
- niversity Hospital of Heidelberg (Germany)
- Enrollment
- 436
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Unifocal, supratentorial recurrent glioma
- •2\. Contrast enhancement on T1\-weighted magnetic resonance imaging (MRI) and/or amino acid positron emission tomography (PET)\-positive high\-grade tumour areas
- •3\. Indication re\-irradiation
- •4\. Aged greater than or equal to 18 years of age, either sex
- •5\. Karnofsky Performance Score greater than or equal to 60
- •6\. For women with childbearing potential, (and men) adequate contraception
- •7\. Ability of subject to understand character and individual consequences of the clinical trial
- •8\. Written informed consent (must be available before enrolment in the trial)
Exclusion Criteria
- •1\. Multifocal glioma or gliomatosis cerebri
- •2\. Refusal of the patients to take part in the study
- •3\. Previous re\-irradiation or prior radiosurgery or prior treatment with interstitial radioactive seeds
- •4\. Time interval of less than 6 months after primary radiotherapy
- •5\. Patients who have not yet recovered from acute toxicities of prior therapies
- •6\. 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
- •7\. Pregnant or lactating women
- •8\. Participation in another clinical study or observation period of competing trials, respectively
Outcomes
Primary Outcomes
Not specified
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