International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing's Sarcoma Family of Tumours

Phase 1

• Conditions: Ewing's Sarcoma Family of Tumours; MedDRA version: 20.0Level: PTClassification code 10015560Term: Ewing's sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002107-17-DK
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-04
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Randomisation R1:
* Any histologically and genetically confirmed ESFT of bone or soft tissue, or round cell sarcomas which are ‘Ewing’s-like’ but negative for EWSR1 gene rearrangement
* Age >2 years and <50 years (from second birthday to 49 years 364 days) at the date of randomisation
* Randomisation =45 days after diagnostic biopsy/surgery
* Patient assessed as medically fit to receive the treatment in either of the R1 treatment arms
* No prior treatment for ESFT other than surgery
* Documented negative pregnancy test for female patients of childbearing potential
* Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where applicable
* Written informed consent from the patient and/or the parent/legal guardian

Randomisation 2:
* Age >5 years (from fifth birthday) at date of randomisation
* Localised tumour
OR
* Metastatic disease and/or regional lymph node(s) involvement only at diagnosis and at least partial response of the metastases and/or regional lymph node(s)
* Consolidation chemotherapy as per protocol intended
* Patient assessed as medically fit to receive zoledronic acid if allocated
* Written informed consent from the patient and/or the parent/legal guardian
Are the trial subjects under 18? yes
Number of subjects for this age range: 470
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Randomisation R1
• 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
Randomisation 2:
* History of dental surgery (extraction or jaw surgery) in the 6 months preceding the start of zoledronic acid treatment, or planned dental surgery within the treatment period or within 6 months after the end of treatment.
*History of jaw fracture
* Ewing’s tumour of the maxilla or of the mandible
* Progression of the primary tumour or appearance of new lesions

Study & Design

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