Clinical Trial: Study of Intensive Chemotherapy, Surgery and Radiotherapy to Treat Ewing's Sarcoma in Children and Young Adults

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase 2, Open-label, Uncontrolled, Multicenter and Prospective Study of Intensive Chemotherapy, Surgery and Radiotherapy to Treat Ewing's Sarcoma in Children and Young Adu

Brief Summary:

Tumors of the Ewing sarcoma family (ES) affect children, adolescents and young adults. The reported incidence is 0.6 cases per million inhabitants every year. The peak incidence occurs between 10 and 20 years and it is rarely diagnosed beyond 30. The ES is a severe disease with a progression-free survival after 5 years of 60% in cases without metastasis and deadly in the majority of patients presenting metastasis. The ES is considered a systemic disease because, despite receiving an adequate local treatment, over 90% of patients deaths occur due to disseminated disease. Combined therapy of surgery, radiotherapy and chemotherapy has led to an improvement in the prognosis, achieving a survival of about 60% in most series

The MSKCC P6 protocol was developed for the treatment of high risk ES. In 2003, Kolb et al. reported the MSKCC experience after a 4-years follow-up of 68 patients who had been included from 1990 to 2001. Following the MSKCC P6 protocol, a survival rate of 82% was achieved in patients without metastasis, superior to the achieved with less intensive protocols. Following the guidelines of the MSKCC P6 protocol, in 2002 we modified the treatment schedule to create the modified P6 protocol (MP6). GEIS intends to develop MP6 as a clinical trial, which could provide the following potential advantages about current treatments:

  1. Lower total dose of alkylating agents.
  2. Early cardioprotection with dexrazoxane.
  3. Radiotherapy adjusted to the initial response.
  4. Pilot trial with the combination of Gemcitabine + Docetaxel for high-risk patients.

Detailed Summary:
Sponsor: Grupo Espanol de Investigacion en Sarcomas

Current Primary Outcome: Progression Free Survival [ Time Frame: Assessment of the progression free survival in all the patients enrolled in the study 3 years after the completion of the treatment under study. ]

Assessment of the progression free survival in all the patients enrolled in the study 3 years after the completion of the treatment under study.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Objective response rate (ORR) [ Time Frame: two months ]
    To assess the objective response rate to treatment (ORR) defined following EMEA criteria (CPMP/EWP/205/95/Rev.3/Corr.2) in high risk patients with Ewing's sarcoma treated with an early window phase of Gemcitabine + docetaxel (G + D).
  • Assessment of disease progression [ Time Frame: to reach an index of disease progression < 20% for high risk patients during the maintenance phase with Gemcitabine + Docetaxel. ]
    To assess the disease progression, aiming to reach an index of disease progression < 20% for high risk patients during the maintenance phase with Gemcitabine + Docetaxel.
  • evaluate the toxicity and tolerance to the treatment Gemcitabine + Docetaxel in high risk patients, and toxicity and tolerance of mP6 treatment in all patients. [ Time Frame: 12 months ]
    To evaluate the toxicity and tolerance to the treatment Gemcitabine + Docetaxel in high risk patients, and toxicity and tolerance of mP6 treatment in all patients.
  • Assessment of bone marrow condition. [ Time Frame: 24 months ]
    Molecular diagnosis and extension study of bone marrow in all patients included in the trial. Assessment of prognostic significance of the type of translocation and the molecular effect in the bone marrow.
  • Study the impact of patients treated with Cardioxane in cardioprotection [ Time Frame: 6 months ]
    Creation of a cohort of patients treated with anthracyclines at high doses and early cardioprotection with dexrazoxane (Cardioxane). Long-term study of cardioprotection in these patients compared with historical series from the P6 protocol that did not received cardioprotection.


Original Secondary Outcome: Same as current

Information By: Grupo Espanol de Investigacion en Sarcomas

Dates:
Date Received: June 30, 2011
Date Started: April 2010
Date Completion: December 2016
Last Updated: August 17, 2015
Last Verified: August 2015