Soft Tissue Sarcoma MedDRA version: 20.0 Level: PT Classification code 10075333 Term: Soft tissue sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: DOXORUBICIN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214-92-8
Product Name: IFOSFAMIDE
Pharmaceutical Form: Powder for solution for inje
Sponsors
INSTITUT CLAUDIUS REGAUD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network 2.According to FNCLCC grading system, grade 2 and grade 1 tumors 3.Resectable and localized disease after appropriate extension work-up (including at least a chest-CT) 4.Available archived FFPE tumor sample in sufficient quantity to allow CINSARC qualification 5.Age = 18 years 6.Eastern Cooperative Oncology Group (ECOG) performance status = 2 7.Life expectancy of at least 12 weeks after the start of the treatment 8.Acceptable hematologic function (within 72 hours of eligibility assessment): Absolute neutrophil count (ANC) = 1.5 G/L, Platelet count = 100 G/L and Hemoglobin > 9g/dL 9.Acceptable renal function within 72 hours of eligibility assessment: Serum creatinine = 1.5 x ULN or calculated creatinine clearance = 60 mL/min (by the Cockcroft and Gault formula) 10.Acceptable liver function: Bilirubin = 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) = 2.5 x ULN 11.Normal LVEF (>50%) measured by echocardiography or isotopic ventriculography 12.Women should be post-menopaused or willing to accept the use an effective contraceptive regimen during the treatment period and at least 12 months after the end of the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to registration. 13.Signed written informed consent 14.Patient affiliated to a Social Health Insurance in France. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcomas, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, epithelioid sarcoma, alveolar or embryonal rhabdomyosarcoma 2.Primitive cutaneous, retroperitoneal, uterus or visceral STS 3.Metastatic disease 4.Previous or ongoing treatment for the sarcoma (with the exception of a surgery for diagnosis intend) 5.Contra-indication for Doxorubicin, Ifosfamide and Dacarbazine treatments 6.Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards, and prior therapy with anthracyclines 7.Prior mediastinal/cardiac radiotherapy 8.History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia, myocardial infarction within 6 months prior to study entry 9.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 10.Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy 11.Known infection with HIV, hepatitis B, or hepatitis C 12.Women who are breastfeeding, pregnant or who plan to become pregnant while in the trial 13.Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study 14.Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice) 15.Patient unable to comply with the protocol for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable FNCLCC grade 1/2 STS, considered as high-risk according to CINSARC.;Secondary Objective: The secondary objectives are: -To compare the two therapeutics strategies in high-risk CINSARC patients with grade 1/2 resectable soft-tissue sarcoma (STS), in terms of: oDisease-free survival, oOverall survival, oSafety profile. -To prospectively validate the prognostic value of CINSARC signature in grade 1/2 STS treated by standard treatment.;Primary end point(s): The primary endpoint is Metastasis-free survival (MFS). MFS is defined by the delay between randomization and the appearance of metastatic disease or death from any cause.;Timepoint(s) of evaluation of this end point: Five years post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: •Disease-free survival (DFS) is defined by the delay between randomization and first relapse (local, regional, or distant) or death from any cause. Patients still alive at the time of analysis (including lost to follow-up) without appearance of relapse will be censored at the last disease assessment date. •Overall survival (OS) is defined by the delay between randomization and death from any cause. Patients still alive at the time of analysis (including lost to follow-up) will be censored at the last known alive date. •Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5.0).;Timepoint(s) of evaluation of this end point: Five years post-randomisation faor each endpoint | — |
Countries
France
Contacts
Public ContactCoordinating Investigator
INSTITUT CLAUDIUS REGAUD
Outcome results
None listed