YonSar: Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma

• Sponsor: PharmaMar, Spain (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02367924
• Collaborator: (none)
• Enrollment: 100
• Locations: 5
• Anticipated Duration (Months): 64.6
• Patients Per Site: 20
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Efficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in Germany.

Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcoma	Drug: trabectedin

Detailed Description

This is a non-interventional, observational and prospective study to evaluate efficacy and safety of trabectedin in routine practice. Patients are assigned to a therapeutic strategy within current practice, not according to a trial protocol. The prescription of the medicine is separated from the decision to include the patient in the study. Diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy.

There are no dose regimens or medical procedures defined within this study plan. Every medical decision and course of treatment with trabectedin will reflect exclusively the decision of the Investigator in a routine clinical situation according to SmPC. The concept of this non-interventional study and its documentation procedure will not affect in any way the routine treatment situation.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Non-interventional Study to Investigate Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma
• Actual Study Start Date: Jul 16, 2015
• Anticipated Primary Completion Date: Jul 1, 2019
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Yondelis The administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy.	Drug: trabectedin; The administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy.; Other Names: Yondelis

Outcome Measures

Primary Outcome Measures

1. 3 months progression free survival (PFS) rate [3 months after start of therapy]

   Number of patients without PD or death 3 months after start of therapy

2. 6 months progression free survival (PFS) rate [6 months after start of therapy]

   Number of patients without PD or death 6 months after start of therapy

Secondary Outcome Measures

1. Tumor control rate [in average 6 months]

   Best response (CR+PR+Disease stabilization) according to institutional standards

2. 3 and 6 months overall survival (OS) rate [3 and 6 months after start of therapy]

   Number of patients alive after 3 months and 6 months

3. Progression free survival (PFS) [in average 6 months]

   Time from start of therapy to the date of documented PD or death (death of any cause)

4. Type of treatment used [2 years]

   dose reductions and postponement of cycles

5. Treatment duration [from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)]

   Number of cycles

6. Reason for discontinuation of trabectedin treatment [from first cycle up to a maximum of 17 cycles, each cycle is 21 days (= 1 year)]

   Analysis of documented reasons

7. General description of grade 3/4 adverse events [2 years]

   Adverse events of grade 3/4 according to NCI CTC V4

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must comply with all of the following criteria in order to be enrolled into the study:

• Histologically diagnosed advanced STS

• Female or male aged 18 years or above

• Signed written informed consent

• Suitable to undergo treatment with trabectedin according to SmPC

• Progress after therapy with anthracyclines and ifosfamide has failed, or if patients are unsuited to receive these agents

Exclusion Criteria:

• Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dokusan GmbH und Co. KG; Praxisklinik Herne / Onkologie	Herne	Nordrhein-Westfalen	Germany	44623
2	MVZ Marien-Hospital-Wesel GmbH	Wesel	Nordrhein-Westfalen	Germany	46483
3	Onkologische Gemeinschaftspraxis Dr. med. Mohm & Dr. med. Prange-Krex	Dresden	Sachsen	Germany	01307
4	Praxis Dr. med. Jens Uhlig	Naunhof	Sachsen	Germany	04683
5	Praxis für Innere Medizin, Hämatologie u. Onkologie	Bremen		Germany	28209

Sponsors and Collaborators

• PharmaMar, Spain

Investigators

• Principal Investigator: Viktor Grünwald, Dr., Hannover Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PharmaMar, Spain
• ClinicalTrials.gov Identifier: NCT02367924
• Other Study ID Numbers: ET-D-023-13
• First Posted: Feb 20, 2015
• Last Update Posted: Nov 16, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Sarcoma; Trabectedin

Study Results

No Results Posted as of Nov 16, 2018