CWS-2007-HR: Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00876031

Collaborator

Cooperative Weichteilsarkom Study Group (Other), Deutsche Kinderkrebsstiftung (Other), Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany (Other), Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria (Other), The Swedish Childhood Solid Tumor Working Group (Other), Polish Paediatric Solid Tumours Study Group (Other), Swiss Pediatric Oncology Group (Other)

320

Enrollment

Locations

Arms

180

Duration (Months)

4.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate whether the addition of oral maintenance chemotherapy with O-TIE (Etoposide, Idarubicin, Trofosfamide) for 6 months improves the event free survival (EFS) in patients with localised high-risk RMS and RMS-like Soft Tissue Sarcoma.

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcoma	Drug: trofosfamide, idarubicin, etoposide	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomised Phase-III Trial of the Cooperative Weichteilsarkom Study Group (CWS) for Localised High-risk Rhabdomyosarcoma and Localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in Children, Adolescents, and Young Adults

Study Start Date :

Jul 1, 2009

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: O-TIE oral maintenance therapy with trofosfamide, idarubicin, and etoposide	Drug: trofosfamide, idarubicin, etoposide oral maintenance therapy for 6 months
No Intervention: control

Arm

Intervention/Treatment

Experimental: O-TIE

oral maintenance therapy with trofosfamide, idarubicin, and etoposide

Drug: trofosfamide, idarubicin, etoposide

oral maintenance therapy for 6 months

No Intervention: control

Outcome Measures

Primary Outcome Measures

event free survival (EFS) [3 years]

Secondary Outcome Measures

Overall survival [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
Rhabdomyosarcoma of the "High Risk" Group, i.e.:
RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
RME, N1, M0, any IRS-group, any size or age
RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
Rhabdomyosarcoma of the "Very High Risk" Group, i.e.:
RMA, N1, MO, IRS II&III, any size or age or
localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
SySa, any N, M0, any size or age (exception: SySa IRSI&II, not T2b, N0, M0 are not eligible)
no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction; hypersensitivity)
no previous malignant tumours
available for long term follow up through the treating centre
in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance

Exclusion Criteria:

pregnant or lactating women
other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)

Contacts and Locations

Locations

	Site	City	Country
1	Universitätsklinik für Kinder- und Jugendheilkunde	Graz	Austria
2	St. Johanns Spital / Landeskrankenhaus	Salzburg	Austria
3	St. Anna Kinderspital	Wien	Austria
4	Charité	Berlin	Germany
5	Helios Klinikum Berlin-Buch	Berlin	Germany
6	Krankenhaus Bielefeld	Bielefeld	Germany
7	Universitätskinderklinik	Bonn	Germany
8	Klinikum Braunschweig	Braunschweig	Germany
9	Prof. Hess Kinderklinik	Bremen	Germany
10	Vestische Kinderklinik	Datteln	Germany
11	Westfälisches Kinderzentrum, Klinikum Dortmund	Dortmund	Germany
12	Universitätsklinikum	Dresden	Germany
13	Universitätskinderklinik	Düsseldorf	Germany
14	Helios Klinikum	Erfurt	Germany
15	Universitätsklinikum	Erlangen	Germany
16	Universitätsklinikum	Essen	Germany
17	Universitätsklinikum	Frankfurt	Germany
18	Universitätsklinikum	Freiburg	Germany
19	Universitätsklinikum	Giessen	Germany
20	Universitätsklinikum	Greifswald	Germany
21	Universitätsklinikum	Göttingen	Germany
22	Universitätsklinikum	Halle	Germany
23	Universitätsklinikum	Hamburg	Germany
24	Medizinische Hochschule	Hannover	Germany
25	Universitätsklinikum	Heidelberg	Germany
26	Universitätsklinikum	Homburg	Germany
27	Universitätsklinikum	Jena	Germany
28	Klinikum Kassel	Kassel	Germany
29	Universitätsklinikum	Kiel	Germany
30	Kliniken der Stadt Köln	Köln	Germany
31	Universitätsklinikum	Köln	Germany
32	Universitätsklinikum	Leipzig	Germany
33	Universitätsklinikum	Lübeck	Germany
34	Universitätsklinikum	Magdeburg	Germany
35	Universitätsklinikum	Mainz	Germany
36	Universitätsklinikum	Mannheim	Germany
37	Dr. von Haunersches Kinderspital	München	Germany
38	Krankenhaus München Schwabing	München	Germany
39	Universitätsklinikum	Münster	Germany
40	Cnopf'sche Kinderklinik	Nürnberg	Germany
41	Klinikum Oldenburg	Oldenburg	Germany
42	Universitätsklinikum	Regensburg	Germany
43	Universitätsklinikum	Rostock	Germany
44	Asklepios Kinderklinik	Sankt Augustin	Germany
45	Olgahospital	Stuttgart	Germany
46	Mutterhaus der Borromäerinnen	Trier	Germany
47	Universitätsklinikum	Tübingen	Germany
48	Universitätsklinikum	Ulm	Germany
49	Universitätsklinikum	Würzburg	Germany
50	Medical University	Białystok	Poland
51	Collegium Medicum	Bydgoszcz	Poland
52	Medical Academy	Gdansk	Poland
53	Silesian Medical Academy	Katowice	Poland
54	Polish-American Institute of Paediatrics Jagiellonian University Medical College	Kraków	Poland
55	Medical Academy	Lublin	Poland
56	Pian Medical University	Szczecin	Poland
57	Department of Surgical Oncology for Children and Youth	Warszawa	Poland
58	Medical University	Wroclaw	Poland
59	Medical Academy	Łódź	Poland
60	Sahlgrenska University Hospital, The Queen Siliva Childrens Hospital	Göteborg	Sweden
61	University Hospital, Dept. of Pediatrics	Linköping	Sweden
62	University Hospital, Dept. of Pediatric Hematology and Oncology	Lund	Sweden
63	Karolinska University Hospital, Astrid Lindgrens Children's Hospital	Stockholm	Sweden
64	Norrland's University Hospital, Dept. of Pediatrics	Umea	Sweden
65	Children's University Hospital	Uppsala	Sweden
66	Kantonsspital	Aarau	Switzerland
67	Universitätskinderklinik beider Basel	Basel	Switzerland
68	Ospedale San Giovanni	Bellinzona	Switzerland
69	Inselspital University hospital	Bern	Switzerland
70	Hopital Cantonal de Geneve	Geneve	Switzerland
71	CHUV	Lausanne	Switzerland
72	Kinderspital	Luzern	Switzerland
73	Ostschweizer Kinderspital	Sankt Gallen	Switzerland
74	University Children's Hospital	Zurich	Switzerland