CWS-2007-HR

автор: CWS, erstellt am: 2010/03/26, Последнее изменение: 2015/06/11

титул A randomised phase-III trial of the Cooperative Soft-Tissue-Study-Group for localised high-risk habdomyosarcoma and localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in children, adolescents, and young adults
Формы рака Localised high-risk rhabdomyosarcoma and localised RMS-like Soft Tissue Sarcoma in remission (according to the CWS-2007-HR definition (see 7.1.8)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-2006 guidance for 25 weeks
Вид исследования Randomised, open-label, multicentric, prospective, non-blinded, phase-IIItrial for localised high-risk Soft Tissue Sarcoma in children, adolescents and young adults <21 years
Цель исследования

Based on the model of SoTiSar the CWS-2007-HR is the first Phase-III-trial that starts on 01.07.2009. The Cooperative-Soft-Tissue-Sarcoma trial CWS-2007-HR is a multinational, multicentric, randomised, open-label, prospective, non-blinded, phase-IIIstudy
for localised high-risk rhadbomyosarcoma and localised high-risk RMS-like STS in children, adolescents, and young adults <21 years to improve treatment outcome.

Лечение

The object of the inquiry is an ambulant oral maintenance chemotherapy with an oral medication over six month. This oral therapy with Etoposide, Idarubicin and Trofosfamide will be randomized against the standard-arm, which is finished after the end of the intensive chemotherapy (no maintenance therapy).
• Arm A: no further therapy
or
• Arm B: 25 weeks of oral maintenace therapy with 8 courses O-TIE

The primary objective is:
1.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.

The secondary objectives are:
2. To investigate, whether the additon of oral maintenance therapy (O-TIE) for 6 months after multimodal standard therapy have impact on following outcomes: overall survival (OS), short-term toxicity and late effects in patients with localised high-risk RMS and RMS-like STS
3. To reassess the European consensus on risk-stratification for RMS within the network of the European paediatric Soft Tissue Sarcoma Study Group (EpSSG)
4. To compare the results of CWS-2007-HR with respect to EFS, OS, short- and long-term toxicities and quality of life (in a cooperation with the Late Effects Board of the GPOH) with the results of previous CWS trials and other trials within the European EpSSG-network:

Only with a randomization of the participating patients it is possible to prove or to disprove, if the additional oral therapy has an effect.

Кого берут в протокол
  • 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
  • age > 6 months and < 21 years at the time of randomisation
  • High-risk Group or Very High Risk Group RMS or eligible RMS-like STS: “High Risk” Group, i.e.:
  • - RME, N0, M0, IRS II&III, >5 cm or > 10 in EXT, HN-PM, OTH or UG-BP
  • - RME, N1, M0, any IRS-group, any size or age
  • - RMA, N0, M0, any IRS-group, any size or age (exception: paratesticular RMA – not eligible
  • or
  • “Very High Risk” Group, i.e.:
  • localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
  • - SySa, any N, M0, any size or age (exception: IRS I&II, not T2b, N0, M0 – not eligible)
  • no pre-existing illness preventing treatment
  • no previous malignant tumours
  • available for long term follow up through the treating centre
  • in remission according to the CWS-2007-HR definition at the time of randomisation* after standard multimodal treatment, e.g. according to CWS-2006 guidance
Кого не берут в протокол
  • pregnant or lactating women
  • other medical condition precluding treatment with protocol chemotherapy (e.g. HIV, psychiatric disorder, etc.)
  • for sexuall active persons in Arm O-TIE: refusal to use contraception
Сколько пациентов должно пройти через исследование 375 Patienten, 320 randomised
Status 01.07.2009-30.06.2015, End of observation: 30.06.2020
EudraCT 2007-001478-10
Entry Study Register
Руководитель протокола Prof. Dr. med. Ewa Koscielniak, Vertretung Prof. Dr. med. Thomas Klingebiel
E-Mail mailto:cws@olgahospital-stuttgart.de
URL http://www.cws.olgahospital-stuttgart.de
С кем можно связаться

Coordination

Dr. med. Tobias Dantonello
Klinikum Stuttgart - Olgahospital
Klinik für Kinder- und Jugendmedizin - Pädiatrie 5
Kriegsbergstrasse 62
70174 Stuttgart
Telefon +49 (711) 278 73870
Fax +49 (711) 278 72749
cws@olgahospital-stuttgart.de

Documentation

Simone Feuchtgruber, Erika Hallmen, Iris Veit-Friedrich
Klinikum Stuttgart - Olgahospital
Klinik f. Kinder-u.Jugendmedizin, Pädiatrie 5, Studienzentrale CWS
Kriegsbergstrasse 62
70174 Stuttgart
Telefon +49 (711) 278-73811/73875
Fax +49 (711) 278 72749
cws.dokumentation@olgahospital-stuttgart.de

Участники исследования Deutschland, Österreich, Polen, Schweden, Schweiz
Weitere Informationen Sponsor nach AMG: Universitätsklinikum Tübingen
Documents
Внутренние ссылки Studienliteratur Weichteilsarkome
Кто финансирует Die Deutsche Kinderkrebsstiftung fördert das Register SoTiSaR und die CWS-2007 HR-Studie.
Der Förderkreis Krebskranke Kinder Stuttgart e.V. unterstützt die Ausstattung der CWS-Studienzentrale.