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Trial record 4 of 124 for:    sarcoma AND metastasis | Recruiting, Not yet recruiting, Available Studies

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

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

Condition or disease Intervention/treatment Phase
Leiomyosarcoma Liposarcoma Synovial Sarcoma Drug: Trabectedin discontinuation Drug: Trabectedin continuation Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
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
Official Title: Time to Secondary Resistance to Trabectedin After Interruption Versus Continuation in Responding Patients With Liposarcoma, Leiomyosarcoma and Synovial Sarcoma
Estimated Study Start Date : February 28, 2019
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2025


Arm Intervention/treatment
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
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

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.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773510


Contacts
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Contact: Emanuela Marchesi, PhD 00393335359 ext 192 clinicaltrials@italiansarcomagroup.org

Locations
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Italy
A.O. SS Antonio e Biagio e Cesare Arrigo Not yet recruiting
Alessandria, AL, Italy, 15100
Contact: Federica Grosso, MD    +390131206155    fgrosso@ospedale.al.it   
Principal Investigator: Federica Grosso, ND         
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST Not yet recruiting
Meldola, FC, Italy
Contact: Toni Ibrahim, MD         
Contact       toni.ibrahim@irst.emr.it   
Principal Investigator: Toni Ibrahim, MD         
Istituto Europeo di Oncologia Not yet recruiting
Milano, MI, Italy, 20141
Contact: Tommaso M. De Pas, MD    +390257489482    tommaso.de-pas@ieo.it   
Principal Investigator: Tommaso M. De Pas, MD         
Istituto Clinico Humanitas Not yet recruiting
Rozzano, MI, Italy, 20089
Contact: Alexia Bertuzzi, MD    +390282244540    alexia.bertuzzi@cancercenter.humanitas.it   
Principal Investigator: Alexia Bertuzzi, MD         
Centro di Riferimento Oncologico di Aviano Not yet recruiting
Aviano, PD, Italy, 33081
Contact: Angela Buonadonna, MD    +39 0434 659190    abuonadonna@cro.it   
Principal Investigator: Angela Buonadonna, MD         
Policlinico Universitario Campus Biomedico Not yet recruiting
Roma, RM, Italy, 00128
Contact: Bruno Vincenzi, MD    +3902225411123    b.vincenzi@unicampus.it   
Principal Investigator: Bruno Vincenzi, MD         
Fondazione del Piemonte per l'Oncologia IRCC Candiolo Not yet recruiting
Candiolo, Torino, Italy, 10060
Contact: Giovanni Grignani, MD    0039-011-9933623    giovanni.grignani@ircc.it   
Contact: Lorenzo D'Ambrosio, MD    0039-011-9933623    lorenzo.dambrosio@ircc.it   
Principal Investigator: Giovanni Grignani, MD         
Sub-Investigator: Lorenzo D'Ambrosio, MD         
Ospedale Gradenigo Not yet recruiting
Torino, TO, Italy, 10153
Contact: Alessandro Comandone, MD    +390118151271    alessandro.comandone@gradenigo.it   
Principal Investigator: Alessandro Comandone, MD         
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors Not yet recruiting
Bologna, Italy, 40136
Contact: Emanuela Palmerini, MD    +390516366199 ext 199    emanuela.palmerini@ior.it   
Principal Investigator: Emanuela Palmerini, MD         
Azienda ospedaliero Universitaria Careggi di Firenze Not yet recruiting
Firenze, Italy
Contact: Lorenzo Livi, MD         
Contact       l.livi@dfc.unifi.it   
Principal Investigator: Lorenzo Livi, MD         
Fondazione IRCCS INT Milano Not yet recruiting
Milano, Italy, 20133
Contact: Roberta Sanfilippo, MD    +390223903 ext 468    roberta.sanfilippo@istitutotumori.mi.it   
Principal Investigator: Roberta Sanfilippo, MD         
Policlinico Federico II Not yet recruiting
Napoli, Italy
Contact: Mario Giuliano, Prof         
Contact       m.giuliano@unina.it   
Principal Investigator: Sabino De Placido, MD         
Irccs Istituto Oncologico Veneto (Iov) Not yet recruiting
Padova, Italy
Contact: Antonella Brunello, MD         
Principal Investigator: Antonella Brunello, MD         
Ospedale Giaccone Not yet recruiting
Palermo, Italy
Contact: Giuseppe Giuseppe, MD         
Principal Investigator: Giuseppe Giuseppe, MD         
Istituti Fisioterapici Ospitalieri di Roma Not yet recruiting
Roma, Italy
Contact: Virginia Ferraresi, MD         
Contact       virginia.ferraresi@ifo.gov.it   
Principal Investigator: Virginia Ferraresi, MD         
Sponsors and Collaborators
Italian Sarcoma Group
PharmaMar
Investigators
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Principal Investigator: Roberta Sanfilippo, MD Fondazione IRCCS INT di Milano

Publications:

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Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT03773510     History of Changes
Other Study ID Numbers: ISG TRADITIONS
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Italian Sarcoma Group:
trabectedin
soft tissue sarcoma

Additional relevant MeSH terms:
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Sarcoma
Sarcoma, Synovial
Leiomyosarcoma
Liposarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents