patients in paediatric age (> 6 months & < 21 years old) with localized rhabdomyosarcoma MedDRA version: 16.0 Level: PT Classification code 10039022 Term: Rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214-92-8
Pharmaceutical Form:
INN or Proposed INN: VINORELBINE
CAS Number: 71486-22-1
Sponsors
Hôpital Universitaire Des Enfants Reine Fabiola (H.U.D.E.R.F.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients with: a)age > 6 months =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: patients with a)age > 21 years; b)metastatic disease; c)previously treated with CT and/or RT; d) pre-existing illness preventing treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the role of doxorubicin dose intensity and vinorelbine maintenance chemotherapy in patients included in the High Risk Group (randomised trial) ;Secondary Objective: to give an homogeneous local and systemic treatment Europe-wide according to the risk of local and metastatic relapse in patients categorized in Low, Standard and Very High risk Groups (observational study) ;Primary end point(s): Intensification question : - Primary end point is "event free survival" Maintenance question - Primary end point is "disease free survival", measured as time from date of second randomisation up to relapse or death. ;Timepoint(s) of evaluation of this end point: Intensification question : "Event free survival" measured as time from date of first randomisation up to an event. Event is defined as: death for all reasons, progression of a residual tumour, relapse following previous complete remission, appearance of a new tumour and switch for a second line chemotherapy in patients without good response. Maintenance question : "disease free survival" measured as time from date of second randomisation up to relapse or death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points for intensification question are: • Overall survival • Progression free survival • response rate in according to classification criteria reported in chapter 19. • toxicity according to NCI-CTC version 3 Secondary end points for maintenance question are: • overall survival • toxicity according to NCI-CTC version 3 ;Timepoint(s) of evaluation of this end point: Secondary end points for intensification question are: • Overall survival, measured as time from date of first randomisation up to death for all reasons. • Progression free survival, measured as time from date of first randomisation up to tumour progression. • response rate in according to classification criteria reported in chapter 19. • toxicity according to NCI-CTC version 3 Secondary end points for maintenance question are: • overall survival, measured as time from date of second randomisation up to death for all reasons. • toxicity according to NCI-CTC version 3 | — |
Countries
Argentina, Belgium, Czech Republic, France, Ireland, Israel, Italy, Netherlands, Norway, Slovakia, Spain, Switzerland, United Kingdom
Contacts
Public ContactChristine Devalck
Hôpital Universitaire Des Enfants Reine Fabiola
Outcome results
None listed