EUROPEAN RHABDOID REGISTRY EU-RHAB PDF

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EUROPEAN RHABDOID REGISTRY V2.2010 15.11.2010

A multinational registry for rhabdoid tumors of any anatomical site

EUROPEAN RHABDOID REGISTRY

EU-RHAB

Contact:

michael.fruehwald@klinikum-augsburg.de, graf@uks.eu

EUROPEAN RHABDOID REGISTRY V2.2010 15.11.2010

EUROPEAN RHABDOID REGISTRY EU-RHAB............................................................................................7

1 GENERAL INFORMATION.................................................................................................................................9

1.1 Investigators ........................................................................................................................................9

1.2 Signature Page..................................................................................................................................10

1.3 Synopsis............................................................................................................................................11

1.4 Important Note...................................................................................................................................12

1.5 Abbreviations.....................................................................................................................................13

2 INTRODUCTION............................................................................................................................................15

3 BACKGROUND..............................................................................................................................................16

3.1 Rationale of a registry for rhabdoid tumors.......................................................................................16

3.2 Rhabdoid tumors - Current knowledge.............................................................................................16

3.2.1 The genetics of rhabdoid tumors..................................................................................................................16

3.2.2 The pathology of rhabdoid tumors................................................................................................................17

3.3 Historical overview of the treatment of rhabdoid tumors...................................................................20

3.3.1 Results of a retrospective analysis of rhabdoid tumors in Germany.............................................................20

3.3.2 The treatment of intracranial rhabdoid tumors (AT/RT)................................................................................20

3.3.3 The treatment of rhabdoid tumors of the kidney (RTK) ................................................................................21

3.3.4 The treatment of rhabdoid tumors of soft tissue (MRT)................................................................................21

3.4 The role of radiotherapy in rhabdoid tumors of the CNS (AT/RT).....................................................22

3.5 The role of intra-ventricular therapy in rhabdoid tumors of the CNS (AT/RT)...................................24

3.6 The role of high dose chemotherapy (HDCT) therapy in rhabdoid tumors .......................................27

4 OBJECTIVES................................................................................................................................................32

4.1 Primary objectives .............................................................................................................................32

4.2 Secondary objectives ........................................................................................................................32

5 INCLUSION INTO THE REGISTRY.....................................................................................................................33

5.1 Inclusion criteria.................................................................................................................................33

5.2 Exclusion criteria ...............................................................................................................................33

6 EUROPEAN RHABDOID REGISTRY - PRIMARY ENDPOINTS....................................................................34

6.1 Institution of a comprehensive registry for rhabdoid tumors .............................................................34

6.2 Pathology review of rhabdoid tumors................................................................................................34

6.3 Molecular genetic evaluation of rhabdoid tumors..............................................................................37

7 DATA MANAGEMENT AND STATISTICAL CONSIDERATIONS................................................................................41

8 ETHICAL AND LEGAL CONSIDERATIONS..........................................................................................................42

9 APPENDIX....................................................................................................................................................43

9.1 References ........................................................................................................................................43

9.2 Participating groups...........................................................................................................................47

9.3 Important addresses..........................................................................................................................51

9.4 Informed consent forms.....................................................................................................................53

9.4.1 Informed consent forms - German...............................................................................................................53

9.4.2 Informed consent forms - English................................................................................................................61

9.5 Case Report Forms ...........................................................................................................................69

9.5.1 Case Report Forms - German.....................................................................................................................69

9.5.2 Case Report Forms - English.......................................................................................................................81

9.6 Forms for Reference Evaluation........................................................................................................93

9.6.1 Forms for Reference Evaluation - German...................................................................................................93

9.6.2 Forms for reference evaluation - English......................................................................................................99

EUROPEAN RHABDOID REGISTRY V2.2010 15.11.2010

PART I: .......................................................................................................................................................107

CONSENSUS THERAPY RECOMMENDATIONS.........................................................................................107

FOR PATIENTS WITH RHABDOID TUMORS OF THE CNS........................................................................107

(AT/RT - ATYPICAL TERATOID / RHABDOID TUMORS)............................................................................107

I.1 DIAGNOSTIC EVALUATION...................................................................................................................... 109

I.2 IMAGING STUDIES - ATYPICAL TERATOID, RHABDOID TUMORS (AT/RT) .................................................... 115

I.3 SURGICAL APPROACH TO PATIENTS WITH AT/RT.................................................................................... 116

I.4 CHEMOTHERAPEUTIC APPROACH TO PATIENTS WITH AT/RT.................................................................... 118

I.4.1 Schematic diagrams for chemotherapy.......................................................................................... 120

I.4.2 Chemotherapy................................................................................................................................ 122

I.4.3 Intraventricular chemotherapy (via rickham reservoir) for patients with AT/RT............................. 127

I.4.4 High Dose Chemotherapy approach (HDCT)................................................................................. 129

I.5 RADIOTHERAPY APPROACH TO PATIENTS WITH AT/RT............................................................................ 132

PART II: .......................................................................................................................................................137

CONSENSUS THERAPY RECOMMENDATIONS.........................................................................................137

FOR PATIENTS WITH RHABDOID TUMORS OF THE KIDNEY ..................................................................137

(RTK - RHABDOID TUMOR OF THE KIDNEY)............................................................................................137

II.1 DIAGNOSTIC EVALUATION...................................................................................................................... 139

II.2 IMAGING STUDIES................................................................................................................................. 145

II.3 SURGICAL APPROACH TO PATIENTS WITH RENAL RHABDOID TUMORS (RTK)............................................. 147

II.4 CHEMOTHERAPEUTIC APPROACH TO PATIENTS WITH RENAL RHABDOID TUMORS (RTK)............................. 148

II.4.1 Schematic diagram of chemotherapy......................................................................................... 150

II.4.2 Chemotherapy............................................................................................................................ 152

II.4.3 High Dose Chemotherapy approach (HDCT)............................................................................. 157

II.5 RADIOTHERAPEUTIC APPROACH TO PATIENTS WITH EXTRACRANIAL RHABDOID TUMORS............................ 160

PART III: .......................................................................................................................................................165

CONSENSUS THERAPY RECOMMENDATIONS.........................................................................................165

FOR PATIENTS WITH RHABDOID TUMORS OF SOFT TISSUE................................................................165

(MRT - MALIGNANT RHABDOID TUMOR OF THE SOFT TISSUE)...........................................................165

III.1 DIAGNOSTIC EVALUATION...................................................................................................................... 167

III.2 IMAGING STUDIES................................................................................................................................. 173

III.3 SURGICAL APPROACH TO PATIENTS WITH EXTRACRANIAL RHABDOID TUMORS........................................... 175

III.4 CHEMOTHERAPEUTIC APPROACH TO PATIENTS WITH MRT ...................................................................... 176

III.4.1 Schematic diagram of chemotherapy......................................................................................... 178

III.4.2 Chemotherapy............................................................................................................................ 180

III.4.3 High Dose Chemotherapy approach (HDCT)............................................................................. 185

III.5 RADIOTHERAPEUTIC APPROACH TO PATIENTS WITH EXTRACRANIAL RHABDOID TUMORS............................ 188

EUROPEAN RHABDOID REGISTRY V2.2010 15.11.2010

5PART IV: .......................................................................................................................................................193

GENERAL INFORMATION, RECOMMENDATIONS AND FORMS...............................................................193

IV.1 DRUG INFORMATION.............................................................................................................................. 195

IV.2 ADVERSE REACTIONS........................................................................................................................... 201

IV.3 SUPPORTIVE CARE................................................................................................................................ 203

IV.4 IMAGING PROTOCOL FOR PATIENTS IN EUROPEAN SIOP BRAIN TUMOUR STUDIES (16.09.09).................. 209

IV.5 INFORMED CONSENT FORMS GERMAN / ENGLISH.................................................................................... 213

IV.5.1: Information and Consent Forms - German................................................................................. 215

IV.5.2: Information and Consent Forms - English................................................................................. 243

IV.6 THERAPEUTIC INTERVENTIONS (OVERVIEW)............................................................................................ 257

IV.6.1 AT/RT (<18 months)................................................................................................................... 259

IV.6.2 AT/RT (>18 months)................................................................................................................... 260

IV.6.3 DOX chemotherapy AT/RT.........................................................................................................261

IV.6.4 ICE chemotherapy AT/RT .......................................................................................................... 262

IV.6.5 VCA chemotherapy AT/RT.........................................................................................................263

IV.6.6 High-dose chemotherapy AT/RT................................................................................................ 264

IV.6.7 RTK / MRT < 18 months............................................................................................................. 265

IV.6.8 RTK / MRT > 18 months............................................................................................................. 266

IV.6.9 DOX chemotherapy RTK / MRT................................................................................................. 267

IV.6.10 ICE chemotherapy RTK / MRT.................................................................................................. 268

IV.6.11 VCA chemotherapy RTK / MRT ................................................................................................ 269

IV.6.12 High-dose chemotherapy RTK / MRT ....................................................................................... 270

IV.7 CASE REPORT FORMS.......................................................................................................................... 273

IV.7.1 Case report forms - German....................................................................................................... 273

IV.7.1.1 Meldung.................................................................................................................................................275

IV.7.1.2 Ersterhebung .........................................................................................................................................277

IV.7.1.3 Chemotherapie ......................................................................................................................................287

IV.7.1.4 intrathekale MTX-Therapie.....................................................................................................................293

IV.7.1.5 Stammzellapherese ...............................................................................................................................297

IV.7.1.6 Hochdosis-Chemotherapie (HDCT) .......................................................................................................299

IV.7.1.7 Second-look-OP.....................................................................................................................................307

IV.7.1.8 Abschluss-Erhebung..............................................................................................................................313

IV.7.1.9 Status-Erhebung....................................................................................................................................315

IV.7.1.10 Ereignismeldung ....................................................................................................................................319

IV.7.1.11 SAE-Meldung.........................................................................................................................................321

IV.7.1.12 Radiotherapie - Basisdaten....................................................................................................................325

IV.7.2 Case report forms - English........................................................................................................ 327

IV.7.2.1 Registration............................................................................................................................................329

IV.7.2.2 Clinical extent at diagnosis.....................................................................................................................331

IV.7.2.3 Chemotherapy .......................................................................................................................................341

IV.7.2.4 intrathecal MTX......................................................................................................................................347

IV.7.2.5 Stem-cell harvest ...................................................................................................................................351

IV.7.2.6 High-dose-chemotherapy (HDCT) .........................................................................................................353

IV.7.2.7 Second look surgery ..............................................................................................................................361

IV.7.2.8 End of treatment ....................................................................................................................................367

IV.7.2.9 Follow-up ...............................................................................................................................................369

IV.7.2.10 Event report............................................................................................................................................373

IV.7.2.11 SAE........................................................................................................................................................375

IV.7.2.12 Radiotherapy - basic data .....................................................................................................................379

IV.8 FORMS FOR REFERENCE EVALUATION.................................................................................................... 381

IV.8.1 Forms for reference evaluation - German................................................................................ 381

IV.8.2 Forms for reference evaluation - English................................................................................... 381

IV.9 CHECKLISTS FOR DOCUMENTATION AND EVALUATION OF PATIENTS.......................................................... 383

IV.10 DECLARATION OF HELSINKI.................................................................................................................... 391

IV.11 ETHICS COMMITTEE APPROVAL.............................................................................................................. 395

EUROPEAN RHABDOID REGISTRY V2.2010 15.11.2010

EUROPEAN RHABDOID REGISTRY EU-RHAB

EUROPEAN RHABDOID REGISTRY V2.2010 15.11.2010

1 General information

1.1 Investigators

Prinicipal Investigator

Coordination Centre: Klinik für Kinder und Jugendliche, Klinikum Augsburg,

Germany

Name: Michael C. Frühwald

Address: Stenglinstr. 2; 86156 Augsburg, Germany

Phone: +49 (0) 821 400-3405

Fax: +49 (0) 821 400-3642

E-Mail: michael.fruehwald@klinikum-augsburg.de

Registry-Mail: eurhab@uni-muenster.de

Data centre (until 03/2011)

University Children's Hospital Münster, Department of

Pediatric Haematology and Oncology

Name: Barbara Krefeld

Address: Domagkstr. 24

Phone: +49 (0) 251 83 56487

Fax: +49 (0) 251 83 47828

E-Mail: barbara.krefeld@ukmuenster.de

Co Investigator

Coordination Centre: University of Saarland, Hospital for Paediatric Oncology and Haematology, Germany

Name: Norbert Graf

Address: Building 9; 66421 Homburg (Saar)

Phone: 0049 6841 1628397

Fax: 0049 6841 1628302

E-Mail: graf@uks.eu

Biometrics

Name: Joachim Gerß

Function/Qualification: Expert Statistician Address: IMIB (Institute for Medical Informatics and

Biomathematics)

Domagkstraße 9, 48149 Münster

Telefon: +49 (0)251 83 57205

Fax: +49 (0)251 83 55277

E-Mail: joachim.gerss@ukmuenster.de

EUROPEAN RHABDOID REGISTRY V2.2010 15.11.2010

1.2 Signature Page

Principal Investigator:

Germany

Name:

Michael Frühwald MD, PhD

Münster 20.10.2010

___________________________

Location, Date

_________________________

Signature

Co-Investigator:

Germany

Name:

Norbert Graf MD

Homburg (Saar) 20.10.2010

___________________________

Location, Date

________________________

Signature

Biometrician:

Germany

Name:

Joachim Gerß PhD Münster 20.10.2010

___________________________

Location, Date

___________________________

Signature

EUROPEAN RHABDOID REGISTRY V2.2010 15.11.2010

1.3 Synopsis

Title:

EUROPEAN RHABDOID REGISTRY

A multinational registry for rhabdoid tumors of any anatomical site

Short title:

EU-RHAB

Investigators / Germany:

Michael C. Frühwald MD, PhD and Norbert Graf MD

Indication:

Rhabdoid tumors of the brain, kidney and soft tissue

Primary objectives:

Creation of a comprehensive database for patients with rhabdoid tumors of any anatomical site diagnosed in European countries. Development of a structured plan for central review of histology (including SMARCB1 immunhistochemistry) and molecular genetics. To improve (neuro-) pathological, clinical and molecular genetic characterization of rhabdoid tumors. To render support to existing tumor banks and to perform biological studies, to identify future therapeutic targets. To cooperate with: Groups specialized in pediatric Soft Tissue Sarcoma (e.g. CWS, EPSSG) and Nephroblastoma, in studying similarities between extra- (RTK and MRT) and intra-CNS (AT/RT) rhabdoid tumors and in defining common treatment elements used in AT/RT and extra-CNS rhabdoid tumours. To communicate with groups in the USA and Australia, to define points of reciprocal interest and potential for cooperation.

Secondary objectives:

To determine event free and overall survival of patients.quotesdbs_dbs1.pdfusesText_1

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[PDF] EUROPEAN RHABDOID REGISTRY EU-RHAB

EUROPEAN RHABDOID REGISTRY

EU-RHAB

Contact:

Table of Contents

1 GENERAL INFORMATION.................................................................................................................................9

1.1 Investigators ........................................................................................................................................9

1.2 Signature Page..................................................................................................................................10

1.3 Synopsis............................................................................................................................................11

1.4 Important Note...................................................................................................................................12

1.5 Abbreviations.....................................................................................................................................13

2 INTRODUCTION............................................................................................................................................15

3 BACKGROUND..............................................................................................................................................16

3.1 Rationale of a registry for rhabdoid tumors.......................................................................................16

3.2 Rhabdoid tumors - Current knowledge.............................................................................................16

3.2.1 The genetics of rhabdoid tumors..................................................................................................................16

3.2.2 The pathology of rhabdoid tumors................................................................................................................17

3.3 Historical overview of the treatment of rhabdoid tumors...................................................................20

3.3.1 Results of a retrospective analysis of rhabdoid tumors in Germany.............................................................20

3.3.2 The treatment of intracranial rhabdoid tumors (AT/RT)................................................................................20

3.3.3 The treatment of rhabdoid tumors of the kidney (RTK) ................................................................................21

3.3.4 The treatment of rhabdoid tumors of soft tissue (MRT)................................................................................21

3.4 The role of radiotherapy in rhabdoid tumors of the CNS (AT/RT).....................................................22

3.5 The role of intra-ventricular therapy in rhabdoid tumors of the CNS (AT/RT)...................................24

3.6 The role of high dose chemotherapy (HDCT) therapy in rhabdoid tumors .......................................27

4 OBJECTIVES................................................................................................................................................32

4.1 Primary objectives .............................................................................................................................32

4.2 Secondary objectives ........................................................................................................................32

5 INCLUSION INTO THE REGISTRY.....................................................................................................................33

5.1 Inclusion criteria.................................................................................................................................33

5.2 Exclusion criteria ...............................................................................................................................33

6 EUROPEAN RHABDOID REGISTRY - PRIMARY ENDPOINTS....................................................................34

6.1 Institution of a comprehensive registry for rhabdoid tumors .............................................................34

6.2 Pathology review of rhabdoid tumors................................................................................................34

6.3 Molecular genetic evaluation of rhabdoid tumors..............................................................................37

7 DATA MANAGEMENT AND STATISTICAL CONSIDERATIONS................................................................................41

8 ETHICAL AND LEGAL CONSIDERATIONS..........................................................................................................42

9 APPENDIX....................................................................................................................................................43

9.1 References ........................................................................................................................................43

9.2 Participating groups...........................................................................................................................47

9.3 Important addresses..........................................................................................................................51

9.4 Informed consent forms.....................................................................................................................53

9.4.1 Informed consent forms - German...............................................................................................................53

9.4.2 Informed consent forms - English................................................................................................................61

9.5 Case Report Forms ...........................................................................................................................69

9.5.1 Case Report Forms - German.....................................................................................................................69

9.5.2 Case Report Forms - English.......................................................................................................................81

9.6 Forms for Reference Evaluation........................................................................................................93

9.6.1 Forms for Reference Evaluation - German...................................................................................................93

9.6.2 Forms for reference evaluation - English......................................................................................................99

5PART IV: .......................................................................................................................................................193

EUROPEAN RHABDOID REGISTRY EU-RHAB

1 General information

1.1 Investigators

Prinicipal Investigator

Germany

Name: Michael C. Frühwald

Phone: +49 (0) 821 400-3405

Fax: +49 (0) 821 400-3642

Registry-Mail: eurhab@uni-muenster.de

Data centre (until 03/2011)

Pediatric Haematology and Oncology

Name: Barbara Krefeld

Phone: +49 (0) 251 83 56487

Fax: +49 (0) 251 83 47828

E-Mail: barbara.krefeld@ukmuenster.de

Co Investigator

Name: Norbert Graf

Phone: 0049 6841 1628397

Fax: 0049 6841 1628302

E-Mail: graf@uks.eu

Biometrics

Name: Joachim Gerß

Biomathematics)

Domagkstraße 9, 48149 Münster

Telefon: +49 (0)251 83 57205

Fax: +49 (0)251 83 55277

E-Mail: joachim.gerss@ukmuenster.de

1.2 Signature Page

Principal Investigator: