Trabectedin for Soft tissue sarcoma

Inclusion criteria

• {"criterion_text":"- 1.\tThe patient must voluntarily sign the informed consent form before performing any study-specific test that is not part of the patient's usual care."}
• {"criterion_text":"- 2.\tAged between 18 and 75 years."}
• {"criterion_text":"- 3.\tThe following histological subtypes may be included in the cohort C: High grade leiomyosarcoma (G2-3), liposarcoma (G2-3), if at least 30% of the tumour is dedifferentiated, pleomorphic liposarcoma. The following histological subtypes may be included in the cohort D: Well differentiated liposarcoma (WD liposarcoma) and G2 dedifferentiated liposarcorcoma, if less than 30% of the tumour is dedifferentiated. A centralised diagnosis will be made to confirm that the patient can be included in the study."}
• {"criterion_text":"- 4.\tThe tumour must be located in the retroperitoneum and it must be resectable and without evidence of regional or distal spread after the appropriate staging process. This point must be confirmed by the central surgeon reviewer."}
• {"criterion_text":"- 5.\tThe location and size of the disease in the retroperitoneum must allow for compliance with radiotherapy limitations in healthy tissue. This point must be confirmed by the site's radiation oncologist and the central radiation oncologist reviewer."}
• {"criterion_text":"- 6.\tMeasurable disease according to CHOI criteria for cohort, and RECIST V 1.1 criteria for cohort D."}
• {"criterion_text":"- 7.\tECOG performance status 0–1."}
• {"criterion_text":"- 8.\tAdequate haematological parameters (haemoglobin >10 g/dl, leukocytes ≥3,000/mm3, neutrophils ≥1,500/mm3, platelets ≥100,000/mm3). Patients with plasma creatinine ≤1.6 mg/dl, transaminases ≤2.5 times the ULN, total bilirubin ≤ ULN, CPK ≤2.5 times ULN, alkaline phosphatase ≤2.5 times ULN are acceptable. If the increase in alkaline phosphatase is >2.5 times the ULN, the liver fraction of alkaline phosphatase and/or GGT should be ≤ULN."}
• {"criterion_text":"- 9.\tFertile men or women must use an effective contraceptive method before starting the study, during the study and for 6 months following the conclusion thereof. Women of childbearing potential who participate in the study must undergo a pregnancy test before starting the study."}
• {"criterion_text":"- 10.\tNormal cardiac function with LVEF ≥50% by echocardiogram or MUGA."}
• {"criterion_text":"- 11.\tHBV and HCV serology must be performed before including the patient in the study. If HbsAg is positive, it is advisable to rule out a replicative phase (HbsAg*, DNA HBV+). If positive, the patient's inclusion in the trial is not recommended, and it is at the discretion of the investigator to administer preventive treatment with lamivudine. If a potential patient is positive to anti-HCV antibodies, the presence of the virus will be ruled out with a qualitative PCR, or the patient cannot be included in the study (if the qualitative PCR test cannot be performed on the patient, they cannot be included in the study)."}
• {"criterion_text":"- 12.\tPatient may have had one previous chemotherapy line (Only Cohort D)."}
• {"criterion_text":"- 13.\tThe patient must have a central venous catheter for the administration of the treatment. -- For cohort A abd B please see the protocol--"}

Exclusion criteria

• {"criterion_text":"- 1.\tUnresectable tumours."}
• {"criterion_text":"- 2.\tLocation other than the retroperitoneum."}
• {"criterion_text":"- 3.\tPatients who have previously received systemic treatment with chemotherapy (trabectedin included). For cohort D, patients may have received one previous line of chemotherapy with any other agent."}
• {"criterion_text":"- 4.\tPatients who underwent prior local treatment for retroperitoneal sarcoma: surgery or radiotherapy in the tumour bed."}
• {"criterion_text":"- 5.\tECOG performance status ≥2."}
• {"criterion_text":"- 6.\tPresence of metastasis or lymph node involvement of the tumour."}
• {"criterion_text":"- 7.\tPrevious history of another neoplastic disease with less than 5 years free of disease except for basal cell carcinoma or properly treated in situ cervical cancer."}
• {"criterion_text":"- 8.\tSignificant cardiovascular disease (e.g. dyspnoea >2 NYHA)."}
• {"criterion_text":"- 9.\tA significant grade 3 or greater systemic disease on the NCI-CTCAE v4.03 scale, which may limit the availability of the patient or which, in the opinion of the investigator, may contribute to the toxicity caused by the study treatment."}
• {"criterion_text":"- 10.\tUncontrolled viral, mycotic or bacterial infections."}
• {"criterion_text":"- 11.\tKnown HIV-positive patients."}
• {"criterion_text":"- 12.\tPregnant or breast-feeding women."}
• {"criterion_text":"- 13.\tPsychological, familial, social or geographical circumstances that limit the patient's ability to comply with the protocol or informed consent form."}
• {"criterion_text":"- 14.\tPatients who have participated in another clinical trial and/or have received another investigational product in the 30 days prior to inclusion in the trial. -- For Cohort A and B please see the protocol --"}

Primary endpoints

• {"endpoint_text":"- To determine the maximum tolerated dose (MTD) or the recommended phase II dose of trabectedin for the combination with radiation therapy. RECIST response for the combination of trabectedin plus radiation therapy in cohorts A, B. CHOI response for the combination of trabectedin plus radiation therapy in cohort C. In cohort D to improve 5-year relapse-free survival (RFS), decreasing the 5-year relapse percentage from 30% to 10% in cohort D patients.","definition_or_measurement_approach":"MTD/RP2D determined by dose-limiting toxicities and safety assessments using CTCAE v4.03; RECIST response assessed per RECIST v1.1 for cohorts A and B; CHOI response criteria used for cohort C; 5-year relapse-free survival (RFS) for cohort D measured as RFS at 5 years (aiming to decrease relapse percentage from 30% to 10%)."}

France

Earliest CTIS Part Ii Submission Date

11-11-2024

Latest Decision Or Authorization Date

27-11-2024

Processing Time Days

16

Number Of Sites

6

Number Of Participants

17

Italy

Earliest CTIS Part Ii Submission Date

30-10-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

33

Number Of Sites

4

Number Of Participants

42

Spain

Earliest CTIS Part Ii Submission Date

30-10-2024

Latest Decision Or Authorization Date

25-11-2024

Processing Time Days

26

Number Of Sites

10

Number Of Participants

104

Primary sponsor

Full Name

Asoc Grupo Espanol De Investigacion En Sarcomas

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain

Contract research organisations

Name

Sofpromed Investigacion Clinica S.L.

Responsibilities

Data Management and Statistical Study (CRO involvement indicated in planDescription: "The information captured in the CRF will be shared with the CRO Softpromed for Data Management and Statistical Study.")

Third parties

• {"country":"Spain","full_name":"Sofpromed Investigacion Clinica S.L.","duties_or_roles":"sponsorDuties codes: 6, 7","organisation_type":"Hospital/Clinic/Other health care facility"}