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Soft Tissue Sarcoma

A Randomized Controlled Study of YONDELIS (trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma

Unique Dataset IDNCT01343277
SponsorJanssen Research & Development, LLCData ProviderJanssen Total Study Enrolled Patients577Comparator (Control) Arm Enrolled Patients193RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyDataset TypeSDTM

Clinical Trial Title

A Randomized Controlled Study of YONDELIS (trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma

Trial Summary and Conditions

This was a randomized, open-label, active-controlled, parallel-group, multicenter study that evaluated the safety and efficacy of trabectedin as compared with dacarbazine in subjects 15 years of age and older with unresectable, locally advanced or metastatic L-sarcoma, who were previously treated (in any order) with at least an anthracycline and ifosfamide containing regimen or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen. Approximately 570 subjects who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1 ratio to either the trabectedin (n?380) or dacarbazine (n?190) treatment groups. Before randomization, subjects will be stratified by the number of lines of prior chemotherapy (1 versus 2 or more), Eastern Cooperative Oncology Group (ECOG) performance Status score (0 versus 1), and L-sarcoma subtype (liposarcoma versus leiomyosarcoma). Radiographic assessment of disease, using the same radiographic technique, was to include radiographic imaging of the chest (with lung views), abdomen and pelvis. Assessment of disease was to be performed every 6 weeks for the first 36 weeks on study and every 9 weeks thereafter, until disease progression occurred, the subject began subsequent anticancer therapy, the study ended, or the subject died. Subsequent therapy was only to be started after disease progression was documented, when possible. Subjects were to be followed for the collection of survival status and the use of subsequent anticancer therapy every 60 days for the first 2 years after the last dose of study drug, and then every 90 days thereafter. Collection of survival status was to continue until approximately 376 deaths were observed (ie, the final analysis clinical cutoff). Safety assessments were to be based on reported adverse events, clinical laboratory, electrocardiograms and MUGA scans (or echocardiograms if MUGA was not available).

Data Summary

Control arm data files include raw data on safety, efficacy, demographic, and baseline disease characteristics and patient reported data.

Study Objectives

The primary objective of this study was to evaluate whether OS for the trabectedin group is superior to the dacarbazine group for subjects with advanced L-type sarcoma who were previously treated (in any order) with at least: a) an anthracycline and ifosfamide containing regimen, or b) an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen. Secondary objectives were to evaluate PFS, TTP, ORR, symptom severity, and safety in the trabectedin group and dacarbazine group.

Outcome Measures

Survival status information was to be used to calculate OS, the study's primary endpoint. Overall survival is defined as the time between randomization and death. Subjects who died, regardless of the cause of death, were to be considered to have had an event. Data from all subjects who were lost to follow-up before the end of the study or who withdrew from the study were to be censored at the time of last contact. Data from subjects who were still being treated were to be censored at the last available date when the subject was known to be alive. Disease response based on investigator assessments using RECIST (Version 1.1) guidelines was to be used to evaluate PFS, TTP, ORR, and DOR. Patient-reported outcomes (PROs) were to be based upon the MDASI questionnaire. Safety was to be evaluated based on the following variables: Adverse events Clinical laboratory tests (hematology and serum chemistry) Vital sign measurements Physical examinations ECGs and MUGA scans

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: ET743SAR3007_Protocol_Amend_INT.pdf

CRF: ET743SAR3007_Annotated_CRF.pdf

DATA DICTIONARY: ET743SAR3007_Data_Dictionary.pdf