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

An Observational, Multicenter, Open-label Study of the Management of Patients With Advanced Soft Tissue Sarcoma After Failure of Anthracyclines and/or Ifosfamide or Patients Unsuited to Receive These Drugs

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

Study Overview

• Status: Completed
• Conditions: Soft Tissue Sarcoma

Detailed Description

• This phase IV study is designed to evaluate, in a real-world setting, usage patterns and associated outcomes associated with the anticancer treatment and/or best supportive care in the clinical practice. The primary study analysis will be to collect clinical data on symptomatic and best response, including tumor control rate, survival, TTP and PFS. Other endpoints of the study will include an evaluation of on-study subsequent anticancer treatments, QoL evaluation by using the EORTC QoL test (QLQ-C30) and an economic cost-effectiveness analysis by using the EQ-5D test.
• The study population will consist of 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. Estimated 100 patients will be enrolled.

• Inclusion Criteria

  1. 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.
  2. 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.
  3. Age ≥ 18 years. Exclusion Criteria Withdrawal of the informed consent at any point of the study will exclude the patient from the study.

• Assigned Intervention

  1. Trabectedin treatment The administration of chemotherapy regimen with trabectedin will be determined by the Investigator's discretion depending on the patients´ conditions and previous chemotherapy.
  2. Other conventional care regimens: other palliative chemotherapy or biological therapy or best supportive care. Patients on the other conventional care regimens could receive the following preselected treatments options:

A.Palliative chemotherapy or biological therapy (such as Ifosfamide or other anticancer agents with antitumor effect) as a palliative systemic therapeutic modality that may be offered to the patient with advanced soft tissue sarcoma.

B.Best supportive care, as a palliative therapeutic modality that may be offered to the patient with soft tissue sarcoma excluding chemotherapy/biological therapy but including radiotherapy and non-anticancer medication. Hence, this includes nutritional support, analgesics, antibiotics, antiemetic, transfusions, appetitive stimulants, antidepressants or any other symptomatic therapy, palliative surgery and/or psychological support and/or deep relaxation therapy. Localized radiotherapy to alleviate symptoms (i.e., pain) will be allowed, provided that the total delivered dose is within a palliative range. All therapies with potential systemic antitumor effect were excluded as BSC definition

• Subsequent Anticancer Treatments Administered After chemotherapy discontinuation, patients with documented progressive disease (PD) may be treated with subsequent anticancer therapies or best supportive care at the Investigators´ discretion. All subsequent treatments, surgical procedures or radiotherapy will be reported in the CRF.
• The study period starts at study inclusion and will continue until treatment discontinuation, death or until the predefined date of April 2014, when a final analysis have to delivered to the Dutch authorities.
• Efficacy Evaluations: Symptomatic response and best response as per the Investigator, according to RECIST will be assessed. Tumor control rate (CR + PR + SD), TTP, PFS and OS will be also evaluated.

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • NKI Amsterdam
  • Groningen, Netherlands, 9700 RB
    • UMC Groningen
  • Leiden, Netherlands, 2300 RC
    • Leiden University
  • Nijmegen, Netherlands, 6500 HB
    • Nijmegen UMCN
  • Rotterdam, Netherlands, 3015E
    • Erasmus MC Rotterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

• Sponsor: PharmaMar
• Investigators: Principal Investigator: A J Gelderblom, Prof, Leiden University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: trabectedin; soft tissue sarcoma; Netherlands
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: ET-D-010-10