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Phase III Trial of Primary Radio- or Chemotherapy in Malignant Astrocytoma of the Elderly

Study Purpose

The study aims to optimize the treatment of elderly subjects (> 65) with anaplastic astrocytoma and glioblastoma. Current treatment policies tend to be no more than palliative. There is no consensus as to how radical the surgery should be. Involved-field radiotherapy is the treatment most likely to be accepted apart from supportive and palliative measures. The role of chemotherapy is barely defined. Study data available to date does not suggest that this patient population would benefit from combined radiochemotherapy. The aim of the study is to verify the hypothesis that first-line chemotherapy with one week on/one week off temozolomide is not inferior to extended-field radiotherapy in the first-line treatment of anaplastic astrocytoma and glioblastoma in the elderly (> 65 age group). The primary endpoint is median survival, as life expectancy is limited to several months. Secondary endpoints are response rates in both arms (CR, PR, MacDonald et al. 1990), median progression-free survival, 1-year and 2-year survival rates, definition of MGMT as molecular genetic prognostic or predictive markers, and quality of life. Theoretically, it should be possible to preserve quality of life in the first-line chemotherapy arm of the study.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 65 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically confirmed supratentorial anaplastic astrocytoma or glioblastoma.
  • - Age > 65.
  • - Karnofsky performance score > 60% - Neutrophilic granulocyte count > 1500/µl.
  • - Platelet count > 100 000/µl.
  • - Hemoglobin > 10 g/dl.
  • - Serum creatinine < 1.5 times the lab's upper normal limit.
  • - AST or ALT < 3 times the lab's upper normal limit.
  • - Alkaline phosphatase < 3 times the lab's upper normal limit.
  • - No previous systemic chemotherapy.
  • - No previous radiotherapy to the brain.
  • - Written consent.

Exclusion Criteria:

  • - Serious medical or neurological condition with a poor prognosis.
  • - HIV infection.
  • - Second cancer requiring radiotherapy or chemotherapy (contact the study coordinat if necessary) - Hypersensitivity to temozolomide.
  • - Conditions associated with regular vomiting that might affect oral administration of the drugs.
  • - Psychological, familial, social or geographical circumstances with major implications for compliance with the study visit schedule.
- Patient was taking part in other intervention studies within a month of starting this study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01502241
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Heidelberg University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michael WellerWolfgang Wick
Principal Investigator Affiliation University of ZurichHeidelberg University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Germany, Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Anaplastic Astrocytoma
Additional Details

This study is a prospective, randomized Phase III intervention study. Following histological documentation of the diagnosis by biopsy or resection of an anaplastic astrocytoma or glioblastoma, patients will be randomized either to receive postoperative extended-field radiotherapy (arm A) or to receive postoperative chemotherapy with temozolomide (arm B). Randomization will be done for all sites at the CRO, Alcedis GmbH. For patients intending to participate in the study, the procedure is as follows:

  • - Request a reference neuropathological review from the brain tumor reference center in Bonn (Prof.
Dr. G. Reifenberger) through the local neuropathology department. This review need not be present at randomization because anaplastic astrocytoma and glioblastoma cases are eligible.
  • - Contact: Prof.
Dr. W. Wick, Dep. Neurooncology, National Center for Tumor Diseases and Neurology Clinic, University of Heidelberg, [email protected] or CRO: Alcedis, Giessen at Alcedis GmbH,
  • I. Helm, Winchester Str.
2, 35394 Gießen, Tel.: 0641 944360, Fax: 0641 94436 70, E-mail: [email protected].
  • - Provide written confirmation that the patient signed the ethics committee-approved consent form.
  • - Submit the registration form and a copy of the EORTC-QLQ given in Annexes.
In subjects with progressive or recurrent disease, the investigating site will verify whether specific tumor treatment is justified. If yes, chemotherapy with temozolomide is recommended in arm A, possibly after further surgery. Subjects in arm B will receive radiotherapy, possible after further surgery. As all-cause mortality is the primary endpoint, all therapeutic measures following first-line therapy should be documented. If study treatment is discontinued (first-line therapy) because of progressive disease or if progression occurs after completion of study treatment, the pertinent images should be submitted to the reference center for neuroradiology in Tübingen for reference review. The treatment modalities employed in the study are chemotherapeutic and radiotherapeutic procedures licensed in the Federal Republic of Germany for use in human subjects. Temozolomide is currently licensed for treating subjects with recurrent disease and since 2006 in newly diagnosed glioblastoma together with radiotherapy. The time allotted for the individual treatment sections is 6 weeks for radiotherapy, while chemotherapy will be continued until progression or unacceptable adverse effects occur. The precise chemotherapy sequence is shown in the protocol. The criteria for withdrawal from the study are defined in in the protocol. Four years is the period scheduled for recruiting all patients.

Arms & Interventions

Arms

Active Comparator: Radiotherapy

6 weeks standard partial brain treatment.

Experimental: Temozolomide

Temozolomide in a one week on/one week off schedule per Wick et al. 2004 and A. Wick et al. 2007

Interventions

Drug: - Temozolomide

100 mg/m2 per day on seven out of fourteen days.

Radiation: - Radiotherapy of the partial brain.

60 Gy in 30 fractions à 2 Gy.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University of Heidelberg, Heidelberg, Baden-Württemberg, Germany

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University of Heidelberg

Heidelberg, Baden-Württemberg, 69120

University of Frankfurt, Frankfurt, Hessen, Germany

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University of Frankfurt

Frankfurt, Hessen, 60528

Charite Berlin, Berlin, Germany

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Charite Berlin

Berlin, ,

University of Bochum, Bochum, Germany

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University of Bochum

Bochum, ,

University of Bonn, Bonn, Germany

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University of Bonn

Bonn, ,

University of Dresden, Dresden, Germany

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University of Dresden

Dresden, ,

University of Düsseldorf, Düsseldorf, Germany

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University of Düsseldorf

Düsseldorf, ,

University of Erlangen, Erlangen, Germany

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University of Erlangen

Erlangen, ,

University of Essen, Essen, Germany

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University of Essen

Essen, ,

University of Freiburg, Freiburg, Germany

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University of Freiburg

Freiburg, ,

University of Hamburg, Hamburg, Germany

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University of Hamburg

Hamburg, ,

University of Hannover II, Hannover, Germany

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University of Hannover II

Hannover, ,

University of Hannover, Hannover, Germany

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University of Hannover

Hannover, ,

University of Homburg, Homburg, Germany

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University of Homburg

Homburg, ,

University of Kiel, Kiel, Germany

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University of Kiel

Kiel, ,

University of Leipzig, Leipzig, Germany

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University of Leipzig

Leipzig, ,

University of Mainz, Mainz, Germany

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University of Mainz

Mainz, ,

University of Heidelberg, Mannheim, Germany

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University of Heidelberg

Mannheim, ,

University of Marburg, Marburg, Germany

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University of Marburg

Marburg, ,

University of Regensburg, Regensburg, Germany

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University of Regensburg

Regensburg, ,

University of Tübingen, Tübingen, Germany

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University of Tübingen

Tübingen, ,

University of Ulm, Ulm, Germany

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University of Ulm

Ulm, ,

University of Zurich, Zurich, Switzerland

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University of Zurich

Zurich, , 8091

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