age 6 Months to 21 Years
Item
age 6 Months to 21 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
Item
written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
boolean
C0021430 (UMLS CUI 2011AA)
pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
Item
pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
boolean
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C1979599 (UMLS CUI 2011AA)
MTHU000098 (LOINC Version 232)
C0456369 (UMLS CUI 2011AA)
277025001 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0035412 (UMLS CUI 2011AA)
302847003 (SNOMED CT 2011_0131)
10039022 (MedDRA 14.1)
C2348205 (UMLS CUI 2011AA)
CL353068 (UMLS CUI 2011AA)
2424003 (SNOMED CT 2011_0131)
Rhabdomyosarcoma of the High Risk Group, i.e.:
Item
Rhabdomyosarcoma of the High Risk Group, i.e.:
boolean
C0035412 (UMLS CUI 2011AA)
302847003 (SNOMED CT 2011_0131)
10039022 (MedDRA 14.1)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
CL415249 (UMLS CUI 2011AA)
RGRP (HL7 V3 2006_05)
RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
Item
RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
boolean
C0206656 (UMLS CUI 2011AA)
404051002 (SNOMED CT 2011_0131)
10065868 (MedDRA 14.1)
C0035412 (UMLS CUI 2011AA)
302847003 (SNOMED CT 2011_0131)
10039022 (MedDRA 14.1)
C0441959 (UMLS CUI 2011AA)
62455006 (SNOMED CT 2011_0131)
C0445034 (UMLS CUI 2011AA)
30893008 (SNOMED CT 2011_0131)
C1320617 (UMLS CUI 2011AA)
405916000 (SNOMED CT 2011_0131)
C0439069 (UMLS CUI 2011AA)
257470002 (SNOMED CT 2011_0131)
C0439070 (UMLS CUI 2011AA)
257471003 (SNOMED CT 2011_0131)
RME, N1, M0, any IRS-group, any size or age
Item
RME, N1, M0, any IRS-group, any size or age
boolean
C0206656 (UMLS CUI 2011AA)
404051002 (SNOMED CT 2011_0131)
10065868 (MedDRA 14.1)
C0441962 (UMLS CUI 2011AA)
53623008 (SNOMED CT 2011_0131)
C0445034 (UMLS CUI 2011AA)
30893008 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C1320617 (UMLS CUI 2011AA)
405916000 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C0456389 (UMLS CUI 2011AA)
246115007 (SNOMED CT 2011_0131)
MTHU010347 (LOINC Version 232)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
Item
RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
boolean
C0206655 (UMLS CUI 2011AA)
404053004 (SNOMED CT 2011_0131)
10065867 (MedDRA 14.1)
C0441959 (UMLS CUI 2011AA)
62455006 (SNOMED CT 2011_0131)
C0445034 (UMLS CUI 2011AA)
30893008 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C1320617 (UMLS CUI 2011AA)
405916000 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C0456389 (UMLS CUI 2011AA)
246115007 (SNOMED CT 2011_0131)
MTHU010347 (LOINC Version 232)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C1562297 (UMLS CUI 2011AA)
415990002 (SNOMED CT 2011_0131)
C0206655 (UMLS CUI 2011AA)
404053004 (SNOMED CT 2011_0131)
10065867 (MedDRA 14.1)
Rhabdomyosarcoma of the Very High Risk Group, i.e.:
Item
Rhabdomyosarcoma of the Very High Risk Group, i.e.:
boolean
C0035412 (UMLS CUI 2011AA)
302847003 (SNOMED CT 2011_0131)
10039022 (MedDRA 14.1)
C0442824 (UMLS CUI 2011AA)
260358002 (SNOMED CT 2011_0131)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
CL415249 (UMLS CUI 2011AA)
RGRP (HL7 V3 2006_05)
RMA, N1, MO, IRS II&III, any size or age or
Item
RMA, N1, MO, IRS II&III, any size or age or
boolean
C0206655 (UMLS CUI 2011AA)
404053004 (SNOMED CT 2011_0131)
10065867 (MedDRA 14.1)
C0441962 (UMLS CUI 2011AA)
53623008 (SNOMED CT 2011_0131)
C0445034 (UMLS CUI 2011AA)
30893008 (SNOMED CT 2011_0131)
C1320617 (UMLS CUI 2011AA)
405916000 (SNOMED CT 2011_0131)
C0439069 (UMLS CUI 2011AA)
257470002 (SNOMED CT 2011_0131)
C0439070 (UMLS CUI 2011AA)
257471003 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C0456389 (UMLS CUI 2011AA)
246115007 (SNOMED CT 2011_0131)
MTHU010347 (LOINC Version 232)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
Item
localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
boolean
C0392752 (UMLS CUI 2011AA)
255471002 (SNOMED CT 2011_0131)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0035412 (UMLS CUI 2011AA)
302847003 (SNOMED CT 2011_0131)
10039022 (MedDRA 14.1)
C2348205 (UMLS CUI 2011AA)
CL353068 (UMLS CUI 2011AA)
2424003 (SNOMED CT 2011_0131)
EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
Item
EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
boolean
C0852530 (UMLS CUI 2011AA)
10015759 (MedDRA 14.1)
C0206663 (UMLS CUI 2011AA)
39781001 (SNOMED CT 2011_0131)
10057846 (MedDRA 14.1)
CL364379 (UMLS CUI 2011AA)
SySa, any N, M0, any size or age (exception: SySa IRSI&II, not T2b, N0, M0 are not eligible)
Item
Synovioma, malignant
boolean
C0039101 (UMLS CUI 2011AA)
63211008 (SNOMED CT 2011_0131)
10042863 (MedDRA 14.1)
no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction, hypersensitivity)
Item
no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction, hypersensitivity)
boolean
C1518422 (UMLS CUI 2011AA)
C2347662 (UMLS CUI 2011AA)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
CL414898 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1522601 (UMLS CUI 2011AA)
C0311400 (UMLS CUI 2011AA)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C1848822 (UMLS CUI 2011AA)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
no previous malignant tumours
Item
no previous malignant tumours
boolean
C1518422 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
available for long term follow up through the treating centre
Item
available for long term follow up through the treating centre
boolean
C0470187 (UMLS CUI 2011AA)
103328004 (SNOMED CT 2011_0131)
C1517942 (UMLS CUI 2011AA)
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
Item
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
boolean
C0544452 (UMLS CUI 2011AA)
277022003 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C2828392 (UMLS CUI 2011AA)
C0009429 (UMLS CUI 2011AA)
pregnant or lactating women
Item
pregnant or lactating women
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
Item
other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
CL411789 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)
Item
for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)
boolean
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0077375 (UMLS CUI 2011AA)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
C0015133 (UMLS CUI 2011AA)
56928005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2733540 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)