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RNOP-09: Pegylated Liposomal Doxorubicine and Prolonged Temozolomide in Addition to Radiotherapy in Newly Diagnosed Glioblastoma - a Phase II Study


Phase 1/Phase 2
18 Years
70 Years
Not Enrolling
Both
Glioblastoma

Thank you

Trial Information

RNOP-09: Pegylated Liposomal Doxorubicine and Prolonged Temozolomide in Addition to Radiotherapy in Newly Diagnosed Glioblastoma - a Phase II Study


Inclusion Criteria:



- newly diagnosed glioblastoma

- centrally confirmed histology

- Karnofsky performance score (KPS) > 70%

- stable corticosteroids within 2 weeks before inclusion

- leucocytes > 3/ul, thrombocytes > 100/ul, Hb > 10 g/dl

- additional standard criteria

Exclusion Criteria:

- other tumor in history

- pretreatment with radiotherapy to the brain

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival probability at 12 months to detect an improvement of the PFS-12 of 15.6% as compared to EORTC26981/NCIC-CE.3 combination arm (PFS-12: 26.9%)

Outcome Time Frame:

12 months after inclusion of last patient

Safety Issue:

No

Principal Investigator

Ulrich Bogdahn, MD, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Neurology, University of Regensburg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

RNOP-09

NCT ID:

NCT00944801

Start Date:

July 2002

Completion Date:

May 2009

Related Keywords:

  • Glioblastoma
  • glioblastoma
  • first-line
  • clinical trial
  • PEG-liposomal doxorubicin
  • temozolomide
  • radiotherapy
  • phase 1
  • phase 2
  • Glioblastoma

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