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Study on Leiomyosarcoma, Liposarcomas and Synovial Sarcoma With Trabectedin (TRADITIONS)

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ClinicalTrials.gov Identifier: NCT03773510
Recruitment Status : Not yet recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Italian Sarcoma Group

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date December 12, 2018
Estimated Study Start Date  ICMJE February 28, 2019
Estimated Primary Completion Date October 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
Time secondary resistance to Trabectedin [ Time Frame: Week 18 ]
Time secondary resistance to Trabectedin is the time from the first trabectedin dose to progression not amenable to treatment with Trabectedin, or death, whichever occurs first
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Overall Survival [ Time Frame: month 6,month 12, month 18, month 24, months 30, month 36, month 42, month 48, month 54, month 60 ]
    Overall Survival is the time from the first trabectedin dose to death for any cause
  • Incidence of adverse event [ Time Frame: Week 9, week 18, week 27, week 36, week 45, week 54, week 63, week 72, week 81 ]
    Adverse events are evaluate from the first trabectedin dose throughout the study according to CTCAE 5.0
  • Progression free survival [ Time Frame: Week 9, week 18, week 27, week 36, week 45, week 54, week 63, week 72, week 81 ]
    Time from the first trabectedin dose to time of onset of progression disease
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on Leiomyosarcoma, Liposarcomas and Synovial Sarcoma With Trabectedin
Official Title  ICMJE Time to Secondary Resistance to Trabectedin After Interruption Versus Continuation in Responding Patients With Liposarcoma, Leiomyosarcoma and Synovial Sarcoma
Brief Summary Two arm, randomized, open-label study, to determine the best time to secondary resistance between responding patients who discontinue treatment and resumed Trabectedin at the time of progression versus patients who continued treatment until progression. T
Detailed Description

This is an Italian, multicenter, randomized, open-label , two arm, study, to determine the best time to secondary resistance between responding patients who discontinue treatment and resumed Trabectedin at the time of progression versus patients who continued treatment until progression. The aim is to evaluate the best clinical practice for responding patients as Trabectedin has an acceptable safety profile with no evidence of cumulative toxicity.

After signing informed consent and being assessed for eligibility criteria , eligible patients will start the trabectedin treatment.

All the patients who will complete 6 cycles of treatment without disease progression will be be randomized to continue Trabectedin versus "treatment interruption" followed by re-challenge at progression. Patients randomized to discontinue treatment will be candidate to other 6 cycles of treatment and if they do not progress, to another interruption. The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under Trabectedin.

The study will be conducted in Italy in approximately 12 centers, in order to recruit 330 evaluable patients over a 4 year period. The follow-up will last approximately 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, open-label , two arm study All the patients who will complete 6 cycles of treatment without disease progression will be be randomized to continue Trabectedin versus "treatment interruption" followed by re-challenge at progression. Patients randomized to discontinue treatment will be candidate to other 6 cycles of treatment and if they do not progress, to another interruption. The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under Trabectedin.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leiomyosarcoma
  • Liposarcoma
  • Synovial Sarcoma
Intervention  ICMJE
  • Drug: Trabectedin discontinuation

    Patients who did not progressed after 6 cycles of trabectedin will stop the treatment and resume drug in case of progression for other 6 cycles.

    The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under trabectedin.

    Other Name: Treatment discontinuation
  • Drug: Trabectedin continuation
    Patients who did not progressed after 6 cycles of trabectedin will continue the treatment until Progressive Disease or unacceptable toxicity
    Other Name: Treatment continuation
Study Arms  ICMJE
  • Active Comparator: Trabectedin continuation
    All the patients who will complete 6 cycles of trabectedin without disease progression, will continue trabectedin until progressive disease, unacceptable toxicity, patient or investigator decision
    Intervention: Drug: Trabectedin continuation
  • Experimental: Trabectedin discontinuation

    All the patients who will complete 6 cycles of trabectedin without disease progression , will discontinue trabectedin.

    The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under trabectedin.

    Intervention: Drug: Trabectedin discontinuation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2025
Estimated Primary Completion Date October 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent and any locally required authorization before any study-specific procedures, including screening evaluations, sampling, and analyses
  2. Diagnosis of well differentiated/dedifferentiated liposarcoma, mixoid round cell liposarcoma, leiomyosarcoma or synovial sarcoma
  3. Persistent or locally relapsed and/or metastatic disease
  4. Pathology specimens available for centralized review (central review is not mandatory prior to start the treatment, but within a month from screening, tumor sample must be sent to central pathology reviewer for a retrospective diagnosis confirmation).
  5. Age ≥ 18 years
  6. Adequate bone marrow function
  7. Adequate organ function,
  8. Eastern Cooperative Oncology Group Performance Status ≤ 2
  9. One or more previous systemic treatments with anthracyclines with or without ifosfamide (unless one or both are clinically contraindicated)
  10. Measurable disease. Patient who received radiotherapy within 3 weeks form the treatment start, can be included as long there is a measurable lesion outside of the irradiation field
  11. A minimum of 3 weeks since any previous chemotherapy treatment
  12. Recovery from toxic effects of prior therapies to (Grade 1 or lower)
  13. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.

Exclusion Criteria:

  1. Pregnant or breast-feeding women
  2. Prior exposure to Trabectedin
  3. Peripheral neuropathy, Grade 2 or higher
  4. History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse
  5. Known central nervous system metastases
  6. Active viral hepatitis or chronic liver disease
  7. Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within six months before enrollment, uncontrolled arterial hypertension or arrhythmia
  8. Active major infection
  9. Previous treatment with any other investigational or not investigational agents within 14 days of first day of study drug dosing
  10. Known history of human immunodeficiency virus infection
  11. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
  12. Other serious concomitant illnesses or any condition that may interfere with the subject's participation in the study or evaluation of the study results
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emanuela Marchesi, PhD 00393335359 ext 192 clinicaltrials@italiansarcomagroup.org
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773510
Other Study ID Numbers  ICMJE ISG TRADITIONS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Italian Sarcoma Group
Study Sponsor  ICMJE Italian Sarcoma Group
Collaborators  ICMJE PharmaMar
Investigators  ICMJE
Principal Investigator: Roberta Sanfilippo, MD Fondazione IRCCS INT di Milano
PRS Account Italian Sarcoma Group
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP