Trial Comparing Trabectedin to the Best Supportive Care in Patients With Sarcoma

NCT02672527 | Completed Phase 3

• 2 other identifiers: 2014-003176-232014/2154
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

As the transparency committee of the Haute Autorité de Santé pointed out due to lack of data regarding comparative trial of Yondelis versus best supportive care, activity of Yondelis in soft tissue sarcoma remain to be assessed. For an antineoplastic drug toxicity is moderate. As previous studies shown, overall survival data for patients with advanced or metastatic STS are of poor prognosis despite improvement of results this last years. For example, median overall survival increased from 12,3 months (1987-1991) to 11,4 months (1992-1996) and then 18 months (2002-2006). Considering the latest results with and without Trabectedin, the investigators may consider that comparing Trabectedin with best supportive care is ethically acceptable as long as patients consent to enter the trial.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Assessed every three weeks after randomization then every six weeks until progression or death of any cause whichever came first up to 30 months

Study Arms (2)

TRA

EXPERIMENTAL

At Day 1 (D1), premedication with dexamethasone (20 mg) and a 5-HT3 receptor antagonist anti-emetic agent will be intravenously administered 30 minutes prior to trabectedin administration. Trabectedin will be administered through a central venous catheter at a starting dose of 1.5 mg/m² over 24 hours, diluted in at least 500 mL of normal saline solution or of glucose 5% injectable solution. Each treatment cycle will last 21 days. Treatment duration: the treatment might be pursued until disease progression according to RECIST 1.1, or patient refusal, or toxicities. In case of disease progression, the further treatments will be based on investigator's judgement.

Drug: Trabectedin; Drug: Dexamethasone

BSC

NO INTERVENTION

Treatment: Patients will receive the best supportive care (BSC) in order to alleviate their symptoms and improve their Quality of Life (QoL). Antineoplastic agents (including surgery, radiotherapy, thermotherapy, chemotherapy, immunotherapy, hormonal treatment or antibodies-based treatments) are prohibited. Treatment duration: the treatment might be pursued until disease progression according to RECIST 1.1, or patient refusal. In case of disease progression, a treatment with trabectedin will be proposed (cross-over). In case of patient refusal, the further treatments will be based on investigator's judgement.

Interventions

Trabectedin DRUG

Also known as: Yondelis

TRA

Dexamethasone DRUG

TRA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent understood, agreed and signed
• Tolerance of the central venous line that will be used for Trabectedin infusions.
• Pathologically confirmed diagnosis of STS at the investigator centre level (and confirmed by Rrepps Network), except the following cases :
• Low grade fibromyxoid sarcoma (LGFMS),
• Giant Cells Fibroblastoma,
• Dermatofibrosarcoma protuberances (DFSP),
• Angiomatoid fibrous histiocytoma,
• Alveolar Rhabdomyosarcoma and Embryonal Rhabdomyosarcoma,
• Mesenchymal and Non-Mesenchymal Chondrosarcoma,
• Extraskeletal Ewing Sarcoma / Primitive Neuroectodermal Tumour (PNET),
• Desmoplastic small round-cell tumour (DSRCT ),
• Gastro-Intestinal Stromal Tumour (GIST),
• Endometrial Stroma Sarcoma,
• Osteosarcoma.
• Histological samples available for centralised histopathological diagnosis and the appropriate genetic diagnosis.

You may not qualify if:

• Hypersensitivity, history of allergic reaction to trabectedin
• History of allergic reaction or known hypersensitivity to dexamethasone or to anti-emetic agents belonging to the triptan family (i.e., 5-HT3 receptor antagonists).
• History of allergic reaction or known hypersensitivity to contrast agents (except if the patient's tumour can be evaluated using MRI without contrast agents).
• Severe concomitant disease (such as pulmonary fibrosis, interstitial pneumonitis, renal insufficiency, liver failure, cerebrovascular disease, malignant disease requiring blood transfusions, or uncontrolled diabetes).
• Clinically significant abnormalities of the electrocardiogram test, or one of the following clinically significant cardiac diseases :
• Congestive cardiac insufficiency,
• Active coronary disease,
• Arrhythmia poorly controlled by medicinal products only,
• Myocardial infarction within one year prior to study entry.
• Surgery under general anaesthesia within 28 days prior to study entry, exploratory surgery (thoracotomy or laparotomy) within 28 days prior to study entry,.
• Treatment with one of the following anticancer agents prior to study entry :
• hormonotherapy within 14 days prior to study entry,
• other anticancer treatment (such as chemotherapy, targeted therapy, or biological advanced therapy) within 21 days prior to study entry.
• Radiotherapy within 21 days prior to study entry.
• History of graft transplantation or stem cell transplantation.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val De Marne, 94805, France

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Trabectedin; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: February 3, 2016
• Study Start: January 22, 2015
• Primary Completion: July 14, 2018
• Study Completion: July 14, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

FR (1)