Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma (EW-1)
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|ClinicalTrials.gov Identifier: NCT02063022|
Recruitment Status : Active, not recruiting
First Posted : February 14, 2014
Last Update Posted : April 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ewing's Sarcoma||Drug: Standard treatment (as per protocol ISG SSG III) Drug: Intensified chemotherapy||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||242 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Study on Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma.|
|Actual Study Start Date :||January 22, 2009|
|Estimated Primary Completion Date :||December 20, 2021|
|Estimated Study Completion Date :||December 20, 2021|
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)
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
- Event Free Survival (EFS) [ Time Frame: 5 years ]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
- Disease Free Survival (DFS) [ Time Frame: expected average 3 years ]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 ]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 ]The OS will be evaluated for the start treatment day to the day of death (for any causes)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063022
|Centro di Riferimento Oncologico - Unit of Medical Oncology|
|Aviano, Pordenone, Italy, 33081|
|I.R.C.C. - Unit of Medical Oncology|
|Candiolo, Torino, Italy, 10060|
|IRCCS materno infantile Burlo Garofolo|
|Trieste, T, Italy, 34137|
|Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari|
|Bari, Italy, 70124|
|Istituto Ortopedico Rizzoli|
|Bologna, Italy, 40136|
|A.O. Universitaria Meyer|
|Firenze, Italy, 50139|
|Istituto Giannina Gaslini|
|FONDAZIONE IRCCS Istituto Nazionale dei Tumori|
|Azienda Ospedaliera Universitaria "Federico Ii" .|
|Napoli, Italy, 80131|
|Azienda Ospedaliera di Padova|
|Azienda Ospedaliero Universitaria Pisana|
|Pisa, Italy, 56126|
|Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I|
|Roma, Italy, 00144|
|Ospedale Pediatrico Bambin Gesu'|
|Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology|
|Torino, Italy, 10126|
|Principal Investigator:||Roberto Luksch, MD||Italian Sarcoma Group|