Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing’s Sarcoma

This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing’s sarcoma

Official Title

EURO-E.W.I.N.G. 99 – European Ewing Tumour Working Initiative of National Groups – Ewing Tumour Studies 1999 – EE 99

Conditions

Ewing’s Sarcoma

Study Type

Interventional

Study Design

Treatment, Randomized, Active Control

Further Details

Primary Outcome Measures:

• Event-free survival
• Overall survival

Secondary Outcome Measures:

• Feasibility, toxicity, and response at 1 month following induction therapy
• Feasibility and toxicity of consolidation regimens at 1 month following consolidation therapy

Study Start

February 2001 to approximately 2008

Eligibility & Criteria

• Ages Eligible for Study: up to 49 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• Histologically confirmed tumor of the Ewing’s family of bone or soft tissue (Ewing’s sarcoma or Peripheral primitive neuroectodermal tumor)
• Disease meeting one of the following criteria: Resectable localized disease (tumor volume less than 200 mL); Localized disease previously resected at diagnosis; Unresectable disease (at least 200 mL tumor volume) but radiotherapy as local control can be delayed; Localized disease with early radiotherapy required; Pulmonary and/or pleural metastases only; Extrapulmonary/pleural metastases (skeleton, bone marrow, lymph nodes)
• No more than 45 days since definitive biopsy
• Age: Under 50
• Renal: Renal function normal; Glomerular filtration rate at least 60 mL/min
• Cardiovascular: Normal cardiac function; Fractional shortening at least 29%; Ejection fraction at least 40%
• No prior chemotherapy
• No medical, psychiatric, or social condition that would preclude study participation

Total Enrolment

1200

Contact Details

Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales, 2145, Australia; Recruiting

• Geoffrey McCowage 61298452122

Royal Children’s Hospital, Herston, Brisbane, Queensland, 4029, Australia; Recruiting

• Helen Irving 617-3636-8671

Women’s and Children’s Hospital, North Adelaide, South Australia, 5006, Australia; Recruiting

• Maria L. Kirby 61881617411

Princess Margaret Hospital for Children, Perth, Western Australia, 6001, Australia; Recruiting

• David Baker 011-6189340-8234

Further information from The National Cancer Institute