Trial Information

Temozolomid (One Week on/One Week Off) Versus Strahlentherapie in Der Primärtherapie Anaplastischer Astrozytome Und Glioblastome Bei älteren Patienten: Eine Randomisierte Phase III-Studie (Methvsalem)

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, wolfgang.wick@med.uni-heidelberg.de or CRO:
Alcedis, Giessen at Alcedis GmbH, I. Helm, Winchester Str. 2, 35394 Gießen, Tel.: 0641
944360, Fax: 0641 94436 70, E-mail: ihe@alcedis.de

- 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.