Clinical Trial: Protocol for the Treatment of Metastatic Ewing Sarcoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Study With High Doses of Chemotherapy, Radiotherapy and Consolidation Therapy With Ciclofosfamide and Anticyclooxygenase 2, for the Metastatic Ewing Sarcoma

Brief Summary: Study for the treatment of metastatic Ewing sarcoma with high doses chemotherapy, radiotherapy and maintenance therapy.

Detailed Summary:

Study for the treatment of Ewing metastatic sarcoma with and induction phase with Vincristine (VIN), Adriamycin (ADM), Ciclofosfamide(CYC), Ifosfamide(IFO), Etoposide(ETO) and radiotherapy (RT)followed by a consolidation phase with Busulfan and Melfalan (BUMEL) and Peripheral Blood Stem Cells Transplantation (PBSCT) and a subsequent maintenance phase with Ciclofosfamide and Celecoxib for High Risk (HR) patients.

Very High Risk (VHR) patients will receive a prior frontline therapy with Temozolomide and Irinotecan (TEMIRI), while patient with lung metastasis only will undergo to total lung irradiation after PBSCT

Sponsor: Italian Sarcoma Group

Current Primary Outcome:

• Overall Survival (OS) [ Time Frame: Expected average 3 year ]
  Evaluation of the OS in patients treated according to the protocol
• Event Free Survival (DFS) [ Time Frame: Expected average 1 year ]
  Evaluation of the time in which the patient do not experience any progression, relapse of toxicity event when treated according to the protocol

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Safety - Incidence and grade of treatment-emergent Adverse Events [ Time Frame: every 21 days up to 1 year ]
  Incidence and grade of treatment-emergent Adverse Events
• Quality of life [ Time Frame: every 3 weeks for the first 6 months and 3 monthly up to 1 year ]
  Evaluation of patient's quality of life: data will be collected by using specific oncologic Quality of Life instruments

Original Secondary Outcome: Same as current

Information By: Italian Sarcoma Group

Dates:
Date Received: March 23, 2016
Date Started: May 2009
Date Completion: May 2020
Last Updated: March 17, 2017
Last Verified: March 2017