Study in Patients With Advanced Soft Tissue Sarcoma (STS) After Failure of Anthracyclines and/or Ifosfamide

NCT01299506 | Completed

• 1 other identifier: ET-D-010-10
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 5

Brief Summary

This is an observational, non-randomized, open label, multicenter, phase IV study, which aims to reflect a real-life practice routinely used for the management of advanced soft tissue sarcoma after failure of anthracyclines and/or ifosfamide or patients unsuited to receive these drugs in the Netherlands. This study pretends to reflect the use and schedule of chemotherapy regimen with trabectedin and/or other conventional care regimens such as other palliative chemotherapy/biological therapies or best supportive care (BSC) in the management of advanced soft tissue sarcoma patients in the clinic based at the discretion of the Investigator. There are no pre-defined limits of administered cycles of trabectedin treatments or chemo- and/or biological therapy; thus, those treatments may continue as long as deemed necessary by the Investigator

Conditions

Soft Tissue Sarcoma

Keywords

soft tissue sarcoma; trabectedin; Netherlands

Study Arms (2)

Trabectedin

The administration of chemotherapy regimen with trabectedin will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy.

Conventional care

This includes other palliative chemotherapy or biological therapy or best supportive care.

Eligibility Criteria

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

Study Population

The study population will include patients with advanced soft tissue sarcoma after failure of anthracyclines and/or ifosfamide or patients unsuited to receive these drugs. To be enrolled in this study, the patients must meet all inclusion criteria and none of the exclusion criteria.

You may qualify if:

• Patients of both sexes with histologically diagnosed advanced soft tissue sarcoma after failure of anthracyclines and/or ifosfamide or patients unsuited to receive these drugs.
• Patients must have signed an informed consent document indicating that they understand the purpose and procedures required for the study, and that they are willing to participate in the study.
• Age ≥ 18 years.

You may not qualify if:

• Withdrawal of the informed consent at any point of the study will exclude the patient from the study.

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (5)

NKI Amsterdam

Amsterdam, 1066 CX, Netherlands

Location

UMC Groningen

Groningen, 9700 RB, Netherlands

Location

Leiden University

Leiden, 2300 RC, Netherlands

Location

Nijmegen UMCN

Nijmegen, 6500 HB, Netherlands

Location

Erasmus MC Rotterdam

Rotterdam, 3015E, Netherlands

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

• A J Gelderblom, Prof

  Leiden University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 18, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 20, 2017

Record last verified: 2012-02

Locations

NL (5)