Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Neuro-Oncology Working Group of the German Cancer Society University Hospital Tuebingen Heinrich-Heine University, Duesseldorf University of Heidelberg Charite University, Berlin, Germany University Hospital, Essen University of Leipzig University Hospital, Bonn German Cancer Research Center, Heidelberg University of Zurich |
---|---|
Information provided by: | Neuro-Oncology Working Group of the German Cancer Society |
ClinicalTrials.gov Identifier: | NCT00717210 |
Background: The optimal treatment of anaplastic gliomas is controversial. Standard of care in most centers is still radiotherapy. This phase III study compared the efficacy and safety of radiotherapy vs chemotherapy in patients (pts) with newly-diagnosed, supratentorial gliomas of WHO grade III.
Methods: Pts were randomized 2:1:1 between June 1999 and February 2005 in 34 German centers to receive (i) a 6-week course of radiotherapy (1,8-2 Gy fractions, total dose 54-60 Gy) or (ii) four 6-week cycles of CCNU at 110 mg mg/m2 on day 1, vincristine at 2 mg on days 8 and 29 and procarbazine at 60 mg/m2 on days 8-21 or eight 4-week cycles of 200 mg/m2 temozolomide on days 1-5. Treatment was stopped prematurely at disease progression or occurrence of unacceptable toxicity. At this time or at disease progression, treatment in the radiotherapy group was continued with one of the chemotherapies (1:1 randomization) and with radiotherapy in both chemotherapy groups. The primary endpoint was time-to-treatment-failure (TTF) defined as progression after radiotherapy and one chemotherapy in either sequence, or any time before if further therapy could not be employed. Assuming a 50% improvement in TTF of starting with chemotherapy, 318 pts were to be enrolled to provide 80% power to achieve statistical significance at a one-sided level of 0.05.
Condition | Intervention | Phase |
---|---|---|
Anaplastic Astrocytoma Oligodendroglioma Oligoastrocytoma |
Drug: Temozolomide Radiation: Focal radiotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | NOA-04 Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide |
Enrollment: | 318 |
Study Start Date: | June 1999 |
Study Completion Date: | March 2008 |
Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Conventional Radiotherapy
|
Radiation: Focal radiotherapy
54-60 Gy in 28-30 fractions over 6-7 weeks
|
B1/2: Experimental
1:1 randomization between temozolomide and procarbazine/lomustine/vincristine (PCV)
|
Drug: Temozolomide
200 mg/m2 body surface on days 1-5 every 28 days for 8 cycles; and again for another 4 cycles at primary progression
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Klinikum Aschaffenburg | |
Aschaffenburg, Germany | |
Nervenklinik | |
Bamberg, Germany | |
Charite | |
Berlin, Germany | |
Neurology | |
Essen, Germany | |
Radiotherapy | |
Erlangen, Germany | |
Neurosurgery | |
Düsseldorf, Germany | |
Neurosurgery | |
Frankfurt, Germany | |
Neurosurgery | |
Kiel, Germany | |
Neurosurgery | |
Mainz, Germany | |
County District Hospital | |
Regensburg, Germany | |
Germany, Baden-Württemberg | |
University of Heidelberg | |
Heidelberg, Baden-Württemberg, Germany, 69120 | |
Neurology and Radiotherapy | |
Tübingen, Baden-Württemberg, Germany, 72076 |
Principal Investigator: | Michael Weller, MD | Department of Neurology, University of Zurich, Switzerland |
Study Director: | Wolfgang Wick, MD | Department of Neurooncology, University of Heidelberg |
Responsible Party: | NOA ( Prof. Dr. Michael Weller ) |
Study ID Numbers: | NOA-04 |
Study First Received: | July 15, 2008 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00717210 History of Changes |
Health Authority: | Germany: Ethics Commission |
1p/19q loss MGMT prognostic factors PCV temozolomide |
Neuroectodermal Tumors Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma |
Antineoplastic Agents, Alkylating Glioma Alkylating Agents Temozolomide Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Neoplasms, Nerve Tissue Temozolomide Pharmacologic Actions Neuroectodermal Tumors Neoplasms |
Therapeutic Uses Neoplasms, Germ Cell and Embryonal Oligodendroglioma Glioma Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Neoplasms, Glandular and Epithelial |