EWING 2008

EWING 2008 - EWING 2008

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46854

Enrollment

Registered

2011-09-12

Start date

2011-10-18

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bone tumour Ewing sarcoma

Interventions

R1 patients. Standard chemotherapy will be given. After local therapy 10 infusion with zoledronic acid will be given. R2 patients: The standard seven courses of consolidation therapy are exchanged

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Histologically confirmed Ewing tumour of bone or soft tissue. ;- Either sex, age >48 months (for GPOH patients) and <50 years at the date of diagnostic biopsy.;- Registration within 45 days after diagnostic biopsy/surgery.;- Start of chemotherapy within 45 days after diagnostic biopsy/surgery.;- Informed consent signed prior to study entry. ;- Lansky or Karnofsky score > 50%, may be modified for handicapped patients.;- Haemoglobin > 8 g/dl, Platelets > 80.000/µl, WBC > 2000/µl.;- LVSF > 40%, FS >28%.

Exclusion criteria

Exclusion criteria: - More than one cycle of chemotherapy prior to registration;- Second malignancy;- Pregnancy and lactation;- Any other medical, psychiatric, or social condition incompatible with the protocol treatment

Design outcomes

Primary

Measure	Time frame
Outcome: To analyse outcome (EFS, OS) of the entire group of patients. Quality of life: To describe the quality of life (QOL) longitudinally (i.e. during the course of treatment and thereafter) in patients and to determine the impact on QOL of the additional treatment (R1 and R3) after randomisation for consolidation treatment. Also when R2 patients have to remain consistent with EURO-E.W.I.N.G. 99, the assessment of QOL within the current trial does not violate any of the basic codes of practice defined within this treatment protocol. Value of Positron Emission Tomography: To examine the value of positron emission tomography in the diagnosis and treatment response of Ewing sarcomas. Time to Diagnosis: To investigate the impact of the time to diagnosis on the presentation and outcome of the patients. Add-on studies: Pharmacogenetic study: SNP-analysis data correlated with response and outcome data	—

Measure

Time frame

Outcome: To analyse outcome (EFS, OS) of the entire group of patients. Quality of life: To describe the quality of life (QOL) longitudinally (i.e. during the course of treatment and thereafter) in patients and to determine the impact on QOL of the additional treatment (R1 and R3) after randomisation for consolidation treatment. Also when R2 patients have to remain consistent with EURO-E.W.I.N.G. 99, the assessment of QOL within the current trial does not violate any of the basic codes of practice defined within this treatment protocol. Value of Positron Emission Tomography: To examine the value of positron emission tomography in the diagnosis and treatment response of Ewing sarcomas. Time to Diagnosis: To investigate the impact of the time to diagnosis on the presentation and outcome of the patients. Add-on studies: Pharmacogenetic study: SNP-analysis data correlated with response and outcome data

—

Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)