Trial record 9 of 56 for:    Open Studies | "Sarcoma, Ewing's"

Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma (EW-1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Italian Sarcoma Group
Sponsor:
Information provided by (Responsible Party):
Italian Sarcoma Group
ClinicalTrials.gov Identifier:
NCT02063022
First received: February 21, 2013
Last updated: February 13, 2014
Last verified: February 2013
  Purpose

Controlled, randomized phase III study, with the intent of optimizing the treatment of not metastatic Ewing Sarcoma. The patients will be randomized into 2 arms: standard treatment vs intensive treatment. Both arms will receive an induction treatment followed by surgery (wherever is possible) and/or radiotherapy. The maintenance treatment will be different on the basis of the response to the induction treatment (good or poor)


Condition Intervention Phase
Ewing's Sarcoma
Drug: Standard treatment (as per protocol ISG SSG III)
Drug: Intensified chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study on Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma.

Resource links provided by NLM:


Further study details as provided by Italian Sarcoma Group:

Primary Outcome Measures:
  • Event Free Survival (EFS) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The EFS (event defined as Progressive Disease , onset of local relapse and/or metastasis, death due to chemotherapy toxicity or for other causes) will be calculated from the first treatment day up to the event onset or to last follow-up


Secondary Outcome Measures:
  • Disease Free Survival (DFS) [ Time Frame: expected average 3 years ] [ Designated as safety issue: No ]
    The DFS will be calculated from the day that the patient will be free from disease (surgery date and/or radiotherapy completion) up to the date of progression disease or last follow-up

  • Metastasis Free Survival [ Time Frame: expected average 2 years ] [ Designated as safety issue: No ]
    The Metastasis free Survival will be evaluated from the time of disease free (surgery performed and/or radiotherapy completed) to the onset of distance metastasis or last follow-up

  • Overall Survival (OS) [ Time Frame: expected average 5 years ] [ Designated as safety issue: Yes ]
    The OS will be evaluated for the start treatment day to the day of death (for any causes)


Estimated Enrollment: 220
Study Start Date: February 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard treatment (as per ISG SSG III protocol)

Standard treatment for non metastatic Ewing's Sarcoma (as defined by the ISG/SSG III protocol).

It is based on a 6 drugs pre-local treatment (Vincristin, dactinomycin, cyclophosphamide,ifosfamide,etoposide and doxorubicin) followed by local treatment (surgery and/or radiotherapy)and by a maintenance treatment based on induction response

Drug: Standard treatment (as per protocol ISG SSG III)
Induction treatment with: 4 cycle of Vincristine (9mg/,2), Dactinomycin (6mg/m2), Doxorubicin (160mg/m2), Cyclophosphamide (2.4g/m2), Ifosfamide (18g/M2) and Etoposide (450mg/m2) given every 3 weeks Maintenance treatment for poor responder (25 weeks): Vincristine (12mg/m2), Dactinomycin (1.5mg/m2), Doxorubicin (320mg/m2), Ifosfamide (27g/m2), Cyclophosphamide (8.8g/m2), Etoposide (1.5g/m2) and peripheral Cells Steam Transplant after Busulfan and Melphalan treatment Maintenance treatment (37 week) for good responder: Vincristine (18mg/m2), Dactinomycin (6mg/m2), Doxorubicin (400mg/m2), Ifosfamide (72g/m2), Cyclosphosphamide(6g/m2), Etoposide (1.8 g/m2)
Other Names:
  • Vincristine
  • Dactinomycin
  • Doxorubicin
  • Ifosfamide
  • Cyclophosphamide
  • Etoposide
  • Busulfan
  • Melphalan
Experimental: Intensified treatment
Dose intense treatment for non metastatic Ewing's Sarcoma It is based on a 3 drug pre-local treatment (Vincristin, ifosfamide and doxorubicin)followed by local treatment (surgery and/or radiotherapy)and by a maintenance treatment based on induction response
Drug: Intensified chemotherapy
  • Induction treatment with: 4 cycle of Vincristine (10.5 mg/m2), Doxorubicin (320 mg/m2) and Ifosfamide (36 mg/m2) given every 3 weeks
  • Maintenance treatment for poor responder (25 weeks): Vincristine (12mg/m2), Doxorubicin (400mg/m2), Ifosfamide (63g/m2), Cyclophosphamide (4g/m2), Etoposide (1.5g/m2) and Cells Steam Transplant after Busulfan and Melphalan treatment
  • Maintenance treatment (25 week) for good responder: Vincristine (12mg/m2), Doxorubicin (400mg/m2), Ifosfamide (72g/m2), Etoposide (1.8g/m2)
Other Names:
  • Vincristine,
  • Doxorubicin
  • Ifosfamide
  • Cyclophosphamide
  • Etoposide
  • Busulfan
  • Melphalan

Detailed Description:

Eligible patients with non metastatic Ewing's Sarcoma will be randomized into 2 different arms: standard treatment arm A (based on the ISG/SSG III protocol) or into the experimental arm B(chemotherapy with dose intensification and shorter length of treatment).

Both arm will receive an induction treatment with higher dose intensity of doxorubicin and ifosfamide in Arm B.

After the induction treatment all the patient will undergo to local treatment (surgery and/or radiotherapy)that will be followed by a maintenance therapy.

The maintenance therapy will be different for both arms and, within each arm, on the basis of the response (histologically evaluated) of the pre-local treatment therapy.

Maintenance for Arm A: Poor responders will undergo to stem cells apheresis and their reinfusion after treatment with high doses of Busulfan and Melphalan 25 weeks.

Good responders will receive a 6 drugs maintenance treatment for 37 weeks (as per standard ISG/SSG III protocol)

Maintenance for Arm B: Poor responders will undergo to stem cells apheresis and their reinfusion after an intensified treatment with high doses of Busulfan and Melphalan (25 weeks).

Good responders will receive a maintenance treatment for 25 weeks

The primary aim of the study is to assess the Event Free Survival (EFS) that is expected to be similar in both arms

The secondary objectives are:

To assess if the induction treatment in Arm B is able to increase the percentage of good responders compared to those who receive standard treatment.

To assess the toxicity and the Quality of Life related to the chemotherapy treatment

  Eligibility

Ages Eligible for Study:   up to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Ewing Sarcoma or PNET diagnosis centrally confirmed
  • Age ≤ 40 years
  • Absence of evident metastasis or lung met < 0.5 cm Presence of skip metastasis in the bone compartment of the primary tumor is to be considered as local disease and not metastatic.
  • Adeguate bone marrow, hepatic and renal function
  • Left Ventricular Ejection Fraction > 50%
  • No primary Ewing Sarcoma treatments (both chemotherapy and/or radiotherapy)
  • Voluntarily signed an informed consent form
  • Radiological and histological documentation available for central review.

Exclusion Criteria

  • Presence of lung or extra-pulmonary lesions
  • Bone Marrow involvement
  • In case of chest disease: presence of plural effusion
  • Elapsed time between histological diagnosis and chemotherapy start, more than 4 weeks
  • Any medical contraindication to the use of the study drugs
  • Any psychological or social conditions that can compromise the protocol compliance and/or follow-up
  • Previous malignancies (excluded in situ cervix carcinoma)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02063022

Contacts
Contact: Stefano Ferrari, MD +390516366 ext 4111 stefano.ferrari@ior.it
Contact: Piero Picci, MD +390516366 ext 6759 piero.picci@ior.it

Locations
Italy
Centro di Riferimento Oncologico - Unit of Medical Oncology Recruiting
Aviano, Pordenone, Italy, 33081
Contact: Maurizio Mascarin, MD    +390434659 ext 536    mascarin@cro.it   
Contact: Maurizio Mascarin, MD    +390434659    mascarin@cro.it   
Principal Investigator: Maurizio Mascarin, MD         
I.R.C.C. - Unit of Medical Oncology Recruiting
Candiolo, Torino, Italy, 10060
Contact: Massimo Aglietta, MD    +39.011.9933 ext 628    massimo.aglietta@ircc.it   
Contact: Luisa Gioeni, Pharmacist    +39.011.9933 ext 278    luisa.gioeni@ircc.it   
Principal Investigator: Massimo Aglietta, MD         
Sub-Investigator: Giovanni Grignani, MD         
Presidio Sanitario Gradenigo Recruiting
Torino, TO, Italy, 10153
Contact: Alessandro Comandone, MD    +390118151 ext 211    alessandro.comandone@gradenigo.it   
Principal Investigator: Alessandro Comandone, MD         
A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna Recruiting
Bologna, Italy, 40138
Contact: Arcangelo Prete, MD    +390516363 ext 111    tmoped@aosp.bo.it   
Principal Investigator: Arcangelo Prete, MD         
Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Stefano Ferrari, MD    +390516366 ext 411    stefano.ferrari@ior.it   
Contact: Emanuela Marchesi, PhD    +390516366 ext 400    emanuela.marchesi@ior.it   
Principal Investigator: Stefano Ferrari, MD         
Servizio di Oncoematologi Pediatrica Ospedale microcitemico ASL 8 Recruiting
Cagliari, Italy, Rosamaria
Contact: Rosamaria Mura, MD         
Principal Investigator: Rosamaria Mura, MD         
A.O. Universitaria Meyer Recruiting
Firenze, Italy, 50139
Contact: Angela Tamburini, MD    +3905556 ext 621    a.tamburini@meyer.it   
Principal Investigator: Angela Tamburini, MD         
Istituto Giannina Gaslini Recruiting
Genova, Italy
Contact: Alberto Garaventa, MD    +390105636 ext 694    albertogaraventa@ospedale-gaslini.ge.it   
Principal Investigator: Alberto Garaventa, MD         
FONDAZIONE IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Italy
Contact: Roberto Luksch, MD         
Principal Investigator: Roberto Luksch, MD         
Azienda Ospedaliera di Padova Recruiting
Padova, Italy
Contact: Gianni Bisogno, MD         
Principal Investigator: Gianni Bisogno, MD         
Ospedale Pediatrico Bambin Gesu' Recruiting
Roma, Italy
Contact: Raffaele Cozza, MD         
Principal Investigator: Raffaele Cozza, MD         
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I Recruiting
Roma, Italy, 00144
Contact: Virginia Ferraresi, MD    +390652666 ext 773    ferraresi@ifo.it   
Contact: , MD         
Principal Investigator: Virginia Ferraresi, MD         
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology Recruiting
Torino, Italy, 10126
Contact: Franca Fagioli, MD    +39.011.3135 ext 230    franca.fagioli@unito.it   
Principal Investigator: Franca Fagioli, MD         
Sponsors and Collaborators
Italian Sarcoma Group
Investigators
Principal Investigator: Stefano Ferrari, MD Italian Sarcoma Group
  More Information

Additional Information:
No publications provided

Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT02063022     History of Changes
Other Study ID Numbers: ISG/AIEOP EW-1
Study First Received: February 21, 2013
Last Updated: February 13, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Italian Sarcoma Group:
Non metastatic Ewing's Sarcoma

Additional relevant MeSH terms:
Sarcoma, Ewing
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Cyclophosphamide
Melphalan
Busulfan
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Etoposide phosphate
Vincristine
Doxorubicin
Etoposide
Dactinomycin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on October 19, 2014