Ewing's Sarcoma Family of Tumours MedDRA version: 16.1 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Vincristine Sulphate
Product Name: Vincristine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Vincristine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed ESFT of bone or soft tissue • Localised or pulmonary and/or pleural metastatic disease • Age >2 years and =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Extrapulmonary metastatic disease • Contra-indication to the treatment in either of the R1 treatment arms • Second malignancy • Pregnant or breastfeeding women • Follow-up not possible due to social, geographic or psychological reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The objective of the zoledronic acid randomisation (R2) is to determine whether the addition of zoledronic acid to consolidation chemotherapy, as assigned at R1, is associated with improved clinical outcome in patients with localised ESFT or with pulmonary and/or pleural metastases only at diagnosis. ;Main Objective: The objective of the induction/consolidation chemotherapy randomisation (R1) is to compare the VIDE strategy (VIDE induction and VAI/VAC consolidation) with the VDC/IE strategy (compressed VDC/IE induction and IE/VC consolidation). The event-free survival (EFS) of the two chemotherapy regimens will be compared, and also the relative toxicity experienced by patients both before and after local control of the primary tumour.;Primary end point(s): Event-free survival (EFS);Timepoint(s) of evaluation of this end point: For each randomisation, EFS is defined as the time from randomisation to first event, where an event is progression without complete remission, recurrence (following complete remission), diagnosis of second malignancy or death. Patients who have not had an event will be censored at their last follow-up date. Patients lost to follow-up without an event will be censored at the date of their last consultation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall Survival (OS) • Adverse events and toxicity, defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0 • Histological response of the primary tumour to induction chemotherapy if surgery is performed as local control. • Primary tumour and lung and/or pleural metastases response • Achievement of local control at the end of treatment • Growth parameters and jaw osteonecrosis (R2 only) ;Timepoint(s) of evaluation of this end point: • Overall Survival (OS) – evaluated continually • Adverse events and toxicity – evaluated after each course of chemotherapy, or as reported • Histological response of the primary tumour to induction chemotherapy if surgery is performed as local control – evaluated at the time of surgery following induction chemotherapy • Primary tumour and lung and/or pleural metastases response-evaluated after 2 cycles (Arm A), or 3 cycles (Arm B). • Achievement of local control at the end of treatment – evaluated at the time of surgery following induction chemotherapy or at the end of treatment or six months after the end of treatment • Growth parameters (R2 only)– evaluated at baseline, end of treatment and at follow up • Jaw osteonecrosis (R2 only)– evaluated at the end of or during treatment | — |
Countries
France, Ireland, Israel, United Kingdom, United States
Contacts
Public ContactJennifer Anderton
University of Birmingham
Outcome results
None listed