Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma (EW-1)
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| ClinicalTrials.gov Identifier: NCT02063022 |
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Recruitment Status :
Completed
First Posted : February 14, 2014
Last Update Posted : September 19, 2022
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| 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 : | 278 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase III Study on Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma. |
| Actual Study Start Date : | January 22, 2009 |
| Actual Primary Completion Date : | April 14, 2022 |
| Actual Study Completion Date : | April 14, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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:
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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
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Drug: Intensified chemotherapy
Other Names:
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- 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)
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| Ages Eligible for Study: | up to 40 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
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
| Italy | |
| 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 | |
| Genova, Italy | |
| FONDAZIONE IRCCS Istituto Nazionale dei Tumori | |
| Milano, Italy | |
| Azienda Ospedaliera Universitaria "Federico Ii" . | |
| Napoli, Italy, 80131 | |
| Azienda Ospedaliera di Padova | |
| Padova, Italy | |
| Azienda Ospedaliero Universitaria Pisana | |
| Pisa, Italy, 56126 | |
| Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I | |
| Roma, Italy, 00144 | |
| Ospedale Pediatrico Bambin Gesu' | |
| Roma, Italy | |
| Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology | |
| Torino, Italy, 10126 | |
| Principal Investigator: | Roberto Luksch, MD | Italian Sarcoma Group |
| Responsible Party: | Italian Sarcoma Group |
| ClinicalTrials.gov Identifier: | NCT02063022 |
| Other Study ID Numbers: |
ISG/AIEOP EW-1 |
| First Posted: | February 14, 2014 Key Record Dates |
| Last Update Posted: | September 19, 2022 |
| Last Verified: | September 2022 |
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Non metastatic Ewing's Sarcoma |
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Sarcoma Sarcoma, Ewing Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Dactinomycin Cyclophosphamide Melphalan Busulfan Ifosfamide Isophosphamide mustard Doxorubicin |
Liposomal doxorubicin Etoposide Etoposide phosphate Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors |