Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma

• Status: Active, not recruiting
• Trial end date: 2021-12-20
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Italian Sarcoma Group
• Treatments: Busulfan; Cyclophosphamide; Dactinomycin; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin; Melphalan; Vincristine

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)