ISRCTN37428883
Completed
Phase 2
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
niversity Hospital of Heidelberg (Germany)0 sites150 target enrollmentJuly 8, 2010
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Primary glioblastoma
- Sponsor
- niversity Hospital of Heidelberg (Germany)
- Enrollment
- 150
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2010 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/20819220 results
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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