CWS-2007-HR: A randomised phase-III trial of the Cooperative Weichteilsarkom Studiengruppe for localised high-risk Rhabdomyosarcoma and localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in children, adolescents and young adults.

Phase 1

• Conditions: localized High Risk Soft Tissue Sarcoma in patients younger than 18 years; MedDRA version: 14.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-001478-10-PL
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-08
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

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
• age > 6 months and <18 years at the time of randomisation
• 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
• no previous malignant tumours
• available for long term follow up through the treating centre
• in remission at the time of randomisation after standard multimodal therapy
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• pregnant or lactating women
• other medical condition precluding treatment with protocol
(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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified