Search En/Fr

PATIENTS ELIGIBLE
FOR THE ACT.IN.SARC STUDY

01

Patients with locally advanced soft tissue sarcoma of the extremities and trunk wall may participate the study. The duration of each patient will include up to 21 days screening phase, an app. 78 days of study treatment (with or without NBTXR3) and a post-surgery safety period (14 days). The end of treatment visit will happen at app. 94 to 101 days, followed by a follow-up period.

02

Patients will be randomized in a 1:1 ratio, stratified by histologic subtype (mixoid liposarcoma versus others) to one of the treatment arms.

03

The inclusion criteria are as follows:

Empty section. Edit page to add content here.

Primary tumor

Relapsed tumor, localized out of previously irradiated area

White Blood Cell (WBC) ≥ 3 x 109 /L

Platelet count ≥ 75 x 109 /L

Haemoglobin ≥ 8 g/dL

Creatinine < 1.5 x ULN

ASAT ≤ 3.0 x ULN

ALAT ≤ 3.0 x ULN

Bilirubin ≤ 1.5 mg/dL

A negative serum/urinary pregnancy test within the 7 days prior to NBTXR3 administration. Patients must be post-menopausal, surgically sterile, or using effective contraception. The definition of effective contraception will be based on the judgment of the investigator.

04

Patients presenting with at least one of the following criterion will be excluded from the study:

Embryonal or alveolar rhabdomyosarcoma
Ewing’s sarcoma
Osteosarcoma
Primitive neuroectodermal tumor
Angiosarcoma
Aggressive fibromatosis
Dermatofibrosarcoma protuberans

The region defined cranially by the xiphoid process of the sternum and the costal margins, and caudally by the line joining the anterior superior iliac spines, both limited by the perpendicular lines crossing both nipples

Chemotherapy
Immunotherapy
Targeted therapy
Gene therapy
Patients planning to receive these treatments during the study

A negative serum/urinary pregnancy test within the 7 days prior to NBTXR3 administration. Patients must be post-menopausal, surgically sterile, or using effective contraception. The definition of effective contraception will be based on the judgment of the investigator.

You are here: HEALTHCARE PROFESSIONAL