Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Histiocytoma, Malignant Fibrous

Hemangioendothelioma

Sarcoma, Synovial

Solitary Fibrous Tumors

Hemangiopericytoma

Neoplasms, Fibrous Tissue

Histiocytoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Hemangioma

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Undifferentiated Pleomorphic Sarcoma

Synovial Sarcoma

Epithelioid Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Trabectedin

Antineoplastic Agents, Alkylating

Alkylating Agents

This study is a single arm study with biomarker analysis

- Trabectedin will be prescribed as per market authorization and will be administered by intraveinous infusion (1,5 mg/m²) every 3 weeks. A treatment cycle is defined as a 3-weeks period

Antoine ITALIANO, MD, PhD

Simone MATHOULIN-PELISSIER, MD, PhD

Antoine ITALIANO

This is a biology driven, monocentric study, designed to identify biomarkers of activity of trabectedin in patients with advanced non-L soft-tissue sarcoma. The aim of this study is to implement high-throughput profiling technologies to identify predictive biomarkers of trabectedin efficacy through sequential tumor biopsies and blood sample collection in sarcoma patients.

The identification of predictive biomarkers of the clinical benefit of trabectedin is a crucial issue to identify potential responders particularly for non-L sarcomas. Considering that the molecular profile of STS can change over time, an analysis of archival tumor material may not be a reliable method to identify predictive biomarkers of response, and thus high-throughput technologies may be promising to identify STS markers for prediction of response to trabectedin. For study purpose, blood and tumor samples will be obtained for genetic and immunological profiling at baseline, during treatment by trabectedin and at disease progression.

Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients

Efficacy of trabectedin is defined as objective response \[OR\] or stable disease \[SD\] \> 6 months. Absence of efficacy is defined as progressive disease \[PD\] within 2 months.

Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.

Institut Bergonié

Anti-Infective Agents

Dacarbazine

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

trabectedin: 1.5 mg/m² - 1.3 mg/m² given in 24-hour continuous infusion every 21 days for 6 cycles

Adriamycin: 75 mg/m2/day, bolus, day 1 every 21 days for 6 cycles Dacarbazine: 400 mg/m2/day, days 1, 2 every 21 days for 6 cycles

Treatment with trabectedin repeated every 21 days for 6 cycles

Treatment with Adriamycin at day 1 every 21 days for 6 cycles

Adriamycin

Treatment with Dacarbazine at days 1 and 2 every 21 days for 6 cycles

Silvia Stacchiotti, MD

Phase II randomized study for the comparison of trabectedin versus doxorubicin plus dacarbazine in patients with advanced solitary fibrous tumor

Patients with solitary fibrous tumor will be randomized to receive 6 cycles of trabectedin or doxorubicin plus dacarbazine.

In case of progression or unacceptable toxicity while under the experimental treatment prior to the completion of the 6 cycles, the patients will be offered to cross to the other arm (trabectedin arm to doxorubicin plus dacarbazine arm and vice versa).

Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor

Solitary Fibrous Tumor: Phase II Study on Trabectedin Versus Adriamycin Plus Dacarbazine in Advanced Patients

evaluate the activity of trabectedin and of adriamycin in combination with dacarbazine, according to Response Evaluation Criteria in Solid Tumor (RECIST), version 1.1

Percentage of patient who experienced Complete or Partial Responses after treatment according to Choi Criteria.

Time from the date of enrollment to date of death

Survival free of progressive disease evaluated from enrollment up to progression according to RECIST, or death

Percentage of patients who have achieved complete response, partial response or stable disease ≥ 6 months

Percentage of patient who experienced Complete or Partial Responses according RECIST 1.1 after cross over

Survival free of progressive disease evaluated from

Safety profile of the treatment evaluated according to Common Terminology Criteria for Adverse Events version 4.03

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients	NCT04008238	Soft Tissue Sar... Undifferentiate... Epithelioid Sar... Solitary Fibrou... Hemangioendothe... Desmoplastic Ro... Synovial Sarcom...	Trabectedin	18 Years -	Institut Bergonié
Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor	NCT03023124	Solitary Fibrou...	Trabectedin Adriamycin Dacarbazine	18 Years -	Italian Sarcoma Group

Spots Global Cancer Trial Database for solitary fibrous tumors