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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by PharmaMar
Sponsor:
Information provided by (Responsible Party):
PharmaMar
ClinicalTrials.gov Identifier:
NCT01299506
First received: February 10, 2011
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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


Condition
Soft Tissue Sarcoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by PharmaMar:

Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299506

Contacts
Contact: Danielle Strens +32 47 856 6004 dstrens@deloitte.com
Contact: Patrik Zintl +34 91 823 4599 pzintl@pharmamar.com

Locations
Netherlands
NKI Amsterdam Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: J Kerst, Dr.    +31 205 12 29 51    j.kerst@nki.nl   
Principal Investigator: J Kerst, Dr.         
UMC Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: A. Reyners, Dr.    +31 503 61 61 61    a.k.l.reyners@int.umcg.nl   
Principal Investigator: A. Reyners, Dr.         
Leiden University Recruiting
Leiden, Netherlands, 2300 RC
Contact: A.J. Gelderblom, Prof    +31 715 26 34 86    A.J.Gelderblom@lumc.nl   
Principal Investigator: A J Gelderblom, Prof         
Nijmegen UMCN Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: W van der Graaf, Prof    +31 243 61 03 53    w.vandergraaf@onco.umcn.nl   
Principal Investigator: W van der Graaf, Prof         
Erasmus MC Rotterdam Recruiting
Rotterdam, Netherlands, 3015E
Contact: S Sleijfer, Dr.    +31 107 04 17 33    s.sleijfer@erasmusmc.nl   
Principal Investigator: S Sleijfer, Dr.         
Sponsors and Collaborators
PharmaMar
Investigators
Principal Investigator: A J Gelderblom, Prof Leiden University Medical Center
  More Information

No publications provided

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT01299506     History of Changes
Other Study ID Numbers: ET-D-010-10
Study First Received: February 10, 2011
Last Updated: February 28, 2012
Health Authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development

Keywords provided by PharmaMar:
soft tissue sarcoma
trabectedin
Netherlands

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Ifosfamide
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014