Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01502241
Status:
COMPLETED
Last Update Posted:
2011-12-30
First Post:
2011-12-24
Brief Title:
Phase III Trial of Primary Radio- or Chemotherapy in Malignant Astrocytoma of the Elderly
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Temozolomid One Week onOne Week Off Versus Strahlentherapie in Der Primärtherapie Anaplastischer Astrozytome Und Glioblastome Bei älteren Patienten Eine Randomisierte Phase III-Studie Methvsalem
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Methusalem
Brief Summary:
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 onone 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
Detailed Description:
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 wolfgangwickmeduni-heidelbergde or CRO Alcedis Giessen at Alcedis GmbH I Helm Winchester Str 2 35394 Gießen Tel 0641 944360 Fax 0641 94436 70 E-mail ihealcedisde
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
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 wolfgangwickmeduni-heidelbergde or CRO Alcedis Giessen at Alcedis GmbH I Helm Winchester Str 2 35394 Gießen Tel 0641 944360 Fax 0641 94436 70 E-mail ihealcedisde
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-01 | REGISTRY | German Cancer Society | None |