Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide (NOA-04)

July 16, 2008 updated by: Neuro-Oncology Working Group of the German Cancer Society

NOA-04 Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

318

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aschaffenburg, Germany
        • Klinikum Aschaffenburg
      • Bamberg, Germany
        • Nervenklinik
      • Berlin, Germany
        • Charité
      • Düsseldorf, Germany
        • Neurosurgery
      • Erlangen, Germany
        • Radiotherapy
      • Essen, Germany
        • Neurology
      • Frankfurt, Germany
        • Neurosurgery
      • Kiel, Germany
        • Neurosurgery
      • Mainz, Germany
        • Neurosurgery
      • Regensburg, Germany
        • County District Hospital
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • University of Heidelberg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Neurology and Radiotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent
  • centrally confirmed anaplastic glioma according to the WHO-classification 1998/2000
  • age ≥ 18 years
  • Karnofsky performance status (KPS) of 70 or higher
  • no prior systemic chemotherapy or radiation therapy of the brain
  • no HIV infection
  • adequate bone marrow reserve, liver function, and renal function
  • Patients on corticosteroids had to be on a stable or decreasing dosage within the 14 days prior to randomization

Exclusion Criteria:

  • Glioblastoma
  • infratentorial localization of the tumor
  • pregnancy or lactation period
  • serious medical or neurological comorbidity
  • additional malignancy requiring radio- or chemotherapy
  • known hypersensitivity against study drugs
  • inability to swallow
  • frequent emesis
  • psychological. familial, sociological or geographical situations impairing compliance with F/U examinations
  • parallel participation in other studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Conventional Radiotherapy
Radiation: Focal radiotherapy
54-60 Gy in 28-30 fractions over 6-7 weeks
Experimental: B1/2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time-to-treatment-failure defined as progression after radiotherapy and one chemotherapy in either sequence
Time Frame: 1999-2008
1999-2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival Overall Survival Toxicity Response rates
Time Frame: 1999-2012
1999-2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuro-Oncology Working Group of the German Cancer Society

Collaborators

Charite University, Berlin, Germany
University of Zurich
University Hospital, Essen
Heinrich-Heine University, Duesseldorf
University of Leipzig
German Cancer Research Center
Heidelberg University
University Hospital, Bonn
University Hospital Tuebingen

Investigators

  • Principal Investigator: Michael Weller, MD, Department of Neurology, University of Zurich, Switzerland
  • Study Director: Wolfgang Wick, MD, Department of Neurooncology, University of Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1999

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

July 15, 2008

First Submitted That Met QC Criteria

July 16, 2008

First Posted (Estimate)

July 17, 2008

Study Record Updates

Last Update Posted (Estimate)

July 17, 2008

Last Update Submitted That Met QC Criteria

July 16, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOA-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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