Ifosfamide for Resectable non-metastatic soft-tissue sarcoma (STS)

Inclusion criteria

• {"criterion_text":"- Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network, as recommended by the French NCI,\n- Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for one year after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier. Subjects of childbearing potential are those who have not been surgically sterilized (e.g., vasectomy for males and hysterectomy for females) or have not been free from menses for ≥ 1 year,\n- Voluntarily signed and dated written informed consents prior to any study specific procedure,\n- Patients with a social security in compliance with the French law.\n- Grade 2 or 3 according to the FNCLCC grading system,\n- Available archived tumour sample for research purpose,\n- Non-metastatic and resectable disease,\n- No prior treatment for the disease under study,\n- Age ≥ 18 years,\n- Life expectancy ≥ 3 months,\n- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,\n- Patients must have measurable disease (lesion in previously irradiated field can be considered as measurable if progressive at inclusion according to RECIST 1.1) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm or ≥ 15mm in case of adenopathy,"}

Exclusion criteria

• {"criterion_text":"- Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, embryonal and alveolar rhabdomyosarcoma,\n- Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,\n- Any other contraindication to anthracycline, ifosfamide or dacarbazine,\n- Participation to a study involving a medical or therapeutic intervention in the last 28 days,\n- Known infection with HIV, hepatitis B, or hepatitis C,\n- Females who are pregnant or breast-feeding,\n- Other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study,\n- Individuals deprived of liberty or placed under legal guardianship,\n- Unwillingness or inability to comply with the study protocol for any reason."}

Primary endpoints

• {"endpoint_text":"- Metastasis progression-free survival (M-PFS) is defined as the time interval between the randomization date and the date of death (whatever the cause), or distant progression, whichever occurs first (DATECAN guidelines, Bellera et al. Annals Oncol 2014).","definition_or_measurement_approach":"Time interval between randomization date and date of death (any cause) or distant progression, whichever occurs first (DATECAN guidelines, Bellera et al. Annals Oncol 2014)."}

Secondary endpoints

• {"endpoint_text":"- Loco-regional relapse-free survival (LR-RFS) is defined as the time interval between the randomization date and the date of death (whatever the cause), or loco-regional progression, whichever occurs first (DATECAN guidelines, Bellera et al. Annals Oncol 2015). Progression-free survival is defined as the time interval between the randomization date and the date of death (whatever the cause) or progression (as per RECIST v1.1), whichever occurs first.\n- Overall survival is defined as the time interval between the randomization date and the date of death (whatever the cause).\n- Best overall response is defined as the best response recorded from randomization until the end of neoadjuvant chemotherapy taking into account any requirement for confirmation as per RECIST v1.1 criteria\n- Histological response is defined based on tumour sample as the average proportion of recognizable cells on the tumour sample [Huvos et al, Arch Pathol Lab Med 1977]. Good histological response is defined as <10% viable cells on the tumour sample.\n- Safety will be described using the common toxicity criteria from the NCI v5.","definition_or_measurement_approach":"LR-RFS, PFS, OS and Best overall response defined as time intervals from randomization to event (death/progression) or best response per RECIST v1.1; Histological response defined by proportion of viable tumour cells (<10% = good response) on tumour sample; Safety described using NCI CTCAE v5."}

France

Earliest CTIS Part Ii Submission Date

14-11-2023

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

832

Number Of Sites

11

Number Of Participants

351

Primary sponsor

Full Name

Institut Bergonie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France