LeiomyosarcomaPhase 3TRADITIONSNCT03773510
Study on Leiomyosarcoma, Liposarcomas and Synovial Sarcoma With Trabectedin
A Phase 3 study testing Trabectedin discontinuation and Trabectedin continuation in people with Leiomyosarcoma and Liposarcoma, run by Italian Sarcoma Group at 15 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leiomyosarcoma, Liposarcoma, Synovial Sarcoma
- What is being tested?
- Trabectedin discontinuation and Trabectedin continuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 15 sitesItaly
- Study dates
- 28 Feb 2019to 1 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Diagnosis of well differentiated/dedifferentiated liposarcoma, mixoid round cell liposarcoma, leiomyosarcoma or synovial sarcoma
- Persistent or locally relapsed and/or metastatic disease
- 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).
- Age ≥ 18 years
- Adequate bone marrow function
Show all 13Show fewer
- Adequate organ function,
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- One or more previous systemic treatments with anthracyclines with or without ifosfamide (unless one or both are clinically contraindicated)
- 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
- A minimum of 3 weeks since any previous chemotherapy treatment
- Recovery from toxic effects of prior therapies to (Grade 1 or lower)
- 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.
Who cannot join
- Pregnant or breast-feeding women
- Prior exposure to Trabectedin
- Peripheral neuropathy, Grade 2 or higher
- 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
- Known central nervous system metastases
- Active viral hepatitis or chronic liver disease
Show all 12Show fewer
- Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within six months before enrollment, uncontrolled arterial hypertension or arrhythmia
- Active major infection
- Previous treatment with any other investigational or not investigational agents within 14 days of first day of study drug dosing
- Known history of human immunodeficiency virus infection
- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
- Other serious concomitant illnesses or any condition that may interfere with the subject's participation in the study or evaluation of the study results
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Italy15 sites
A.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, AL, 15100
Centro di Riferimento Oncologico di Aviano
Aviano, PD, 33081
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, 40136
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, 10060
Azienda ospedaliero Universitaria Careggi di Firenze
Florence
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
Meldola, FC
Istituto Europeo di Oncologia
Milan, MI, 20141
Fondazione IRCCS INT Milano
Milan, 20133
Policlinico Federico II
Naples
Irccs Istituto Oncologico Veneto (Iov)
Padova
Ospedale Giaccone
Palermo
Policlinico Universitario Campus Biomedico
Roma, RM, 00128
Istituti Fisioterapici Ospitalieri di Roma
Roma
Istituto Clinico Humanitas
Rozzano, MI, 20089
Ospedale Gradenigo
Torino, TO, 10153
About this study
Official title: Time to Secondary Resistance to Trabectedin After Interruption Versus Continuation in Responding Patients With Liposarcoma, Leiomyosarcoma and Synovial Sarcoma
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
Read the 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.
- Conditions
- Leiomyosarcoma, Liposarcoma, Synovial Sarcoma
- Being tested
- Trabectedin discontinuation, Trabectedin continuation
- Keywords
- trabectedin, soft tissue sarcoma
- Medical subject headings
- Leiomyosarcoma, Liposarcoma, Sarcoma, Synovial, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabectedin discontinuationDrug
Also called Treatment 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.
Trabectedin continuationDrug
Also called Treatment continuation
Patients who did not progressed after 6 cycles of trabectedin will continue the treatment until Progressive Disease or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Trabectedin continuation | Active comparator | 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 Receives: Drug: Trabectedin continuation |
| Trabectedin discontinuation | Experimental | 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. Receives: Drug: Trabectedin discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time secondary resistance to Trabectedin
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
Measured: Week 18
Secondary outcomes (3)
Overall Survival
Overall Survival is the time from the first trabectedin dose to death for any cause
Measured: month 6,month 12, month 18, month 24, months 30, month 36, month 42, month 48, month 54, month 60
Incidence of adverse event
Adverse events are evaluate from the first trabectedin dose throughout the study according to CTCAE 5.0
Measured: Week 9, week 18, week 27, week 36, week 45, week 54, week 63, week 72, week 81
Progression free survival
Time from the first trabectedin dose to time of onset of progression disease
Measured: Week 9, week 18, week 27, week 36, week 45, week 54, week 63, week 72, week 81
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start28 Feb 2019 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Why it stopped: Not approved by the coordinating Ethical Committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LeiomyosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italian Sarcoma Group
- Sponsor type
- Research network
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
- Investigators
- Roberta Sanfilippo, MD, Principal investigator, Fondazione IRCCS INT di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773510
- Sponsor's protocol ID
- ISG TRADITIONS
- Acronym
- TRADITIONS
- Status last verified
- May 2019
- First submitted
- 10 Dec 2018
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Incalci M, Galmarini CM. A review of trabectedin (ET-743): a unique mechanism of action. Mol Cancer Ther. 2010 Aug;9(8):2157-63. doi: 10.1158/1535-7163.MCT-10-0263. Epub 2010 Jul 20.
PubMed 20647340Demetri GD, von Mehren M, Jones RL, Hensley ML, Schuetze SM, Staddon A, Milhem M, Elias A, Ganjoo K, Tawbi H, Van Tine BA, Spira A, Dean A, Khokhar NZ, Park YC, Knoblauch RE, Parekh TV, Maki RG, Patel SR. Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial. J Clin Oncol. 2016 Mar 10;34(8):786-93. doi: 10.1200/JCO.2015.62.4734. Epub 2015 Sep 14.
PubMed 26371143Sanfilippo R, Dileo P, Blay JY, Constantinidou A, Le Cesne A, Benson C, Vizzini L, Contu M, Baldi GG, Dei Tos AP, Casali PG. Trabectedin in advanced synovial sarcomas: a multicenter retrospective study from four European institutions and the Italian Rare Cancer Network. Anticancer Drugs. 2015 Jul;26(6):678-81. doi: 10.1097/CAD.0000000000000228.
PubMed 25763543Grosso F, Dileo P, Sanfilippo R, Stacchiotti S, Bertulli R, Piovesan C, Jimeno J, D'Incalci M, Gescher A, Casali PG. Steroid premedication markedly reduces liver and bone marrow toxicity of trabectedin in advanced sarcoma. Eur J Cancer. 2006 Jul;42(10):1484-90. doi: 10.1016/j.ejca.2006.02.010. Epub 2006 Jun 5.
PubMed 16737808Le Cesne A, Blay JY, Domont J, Tresch-Bruneel E, Chevreau C, Bertucci F, Delcambre C, Saada-Bouzid E, Piperno-Neumann S, Bay JO, Mir O, Ray-Coquard I, Ryckewaert T, Valentin T, Isambert N, Italiano A, Clisant S, Penel N. Interruption versus continuation of trabectedin in patients with soft-tissue sarcoma (T-DIS): a randomised phase 2 trial. Lancet Oncol. 2015 Mar;16(3):312-9. doi: 10.1016/S1470-2045(15)70031-8. Epub 2015 Feb 11.
PubMed 25680558
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Secondary Resistance to Trabectedin After Interruption Versus Continuation in Responding Patients With Liposarcoma, Leiomyosarcoma and Synovial Sarcoma
- ClinicalTrials.gov ID
- NCT03773510
- Acronym / sponsor ID
- TRADITIONS / ISG TRADITIONS
- Conditions
- Leiomyosarcoma, Liposarcoma, Synovial Sarcoma
- Keywords
- trabectedin, soft tissue sarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not approved by the coordinating Ethical Committee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Italian Sarcoma GroupResearch network
- Collaborators
- PharmaMar
- Study start
- 28 Feb 2019 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Trabectedin continuation | Active comparator | Drug: Trabectedin continuationAll the patients who will complete 6 cycles of trabectedin without disease progression, will continue trabectedin until progressive disease, unacceptable toxicity, patient or investigator decision |
| Trabectedin discontinuation | Experimental | Drug: Trabectedin discontinuationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Diagnosis of well differentiated/dedifferentiated liposarcoma, mixoid round cell liposarcoma, leiomyosarcoma or synovial sarcoma
- Persistent or locally relapsed and/or metastatic disease
- 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).
- Age ≥ 18 years
Key exclusion criteria (12 listed)
- Pregnant or breast-feeding women
- Prior exposure to Trabectedin
- Peripheral neuropathy, Grade 2 or higher
- 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
- Known central nervous system metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trabectedin discontinuationAlso: Treatment discontinuationPatients 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. | Drug | Trabectedin discontinuation |
| Trabectedin continuationAlso: Treatment continuationPatients who did not progressed after 6 cycles of trabectedin will continue the treatment until Progressive Disease or unacceptable toxicity | Drug | Trabectedin continuation |
Primary outcome
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
3 secondary outcomes
Overall Survival
Time frame: month 6,month 12, month 18, month 24, months 30, month 36, month 42, month 48, month 54, month 60
Incidence of adverse event
Time frame: Week 9, week 18, week 27, week 36, week 45, week 54, week 63, week 72, week 81
Progression free survival
Time frame: Week 9, week 18, week 27, week 36, week 45, week 54, week 63, week 72, week 81
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Background: PubMed 20647340D'Incalci M, Galmarini CM. A review of trabectedin (ET-743): a unique mechanism of action. Mol Cancer Ther. 2010 Aug;9(8):2157-63. doi: 10.1158/1535-7163.MCT-10-0263. Epub 2010 Jul 20.
- Background: PubMed 26371143Demetri GD, von Mehren M, Jones RL, Hensley ML, Schuetze SM, Staddon A, Milhem M, Elias A, Ganjoo K, Tawbi H, Van Tine BA, Spira A, Dean A, Khokhar NZ, Park YC, Knoblauch RE, Parekh TV, Maki RG, Patel SR. Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial. J Clin Oncol. 2016 Mar 10;34(8):786-93. doi: 10.1200/JCO.2015.62.4734. Epub 2015 Sep 14.
- Background: PubMed 25763543Sanfilippo R, Dileo P, Blay JY, Constantinidou A, Le Cesne A, Benson C, Vizzini L, Contu M, Baldi GG, Dei Tos AP, Casali PG. Trabectedin in advanced synovial sarcomas: a multicenter retrospective study from four European institutions and the Italian Rare Cancer Network. Anticancer Drugs. 2015 Jul;26(6):678-81. doi: 10.1097/CAD.0000000000000228.
- Background: PubMed 16737808Grosso F, Dileo P, Sanfilippo R, Stacchiotti S, Bertulli R, Piovesan C, Jimeno J, D'Incalci M, Gescher A, Casali PG. Steroid premedication markedly reduces liver and bone marrow toxicity of trabectedin in advanced sarcoma. Eur J Cancer. 2006 Jul;42(10):1484-90. doi: 10.1016/j.ejca.2006.02.010. Epub 2006 Jun 5.
- Background: PubMed 25680558Le Cesne A, Blay JY, Domont J, Tresch-Bruneel E, Chevreau C, Bertucci F, Delcambre C, Saada-Bouzid E, Piperno-Neumann S, Bay JO, Mir O, Ray-Coquard I, Ryckewaert T, Valentin T, Isambert N, Italiano A, Clisant S, Penel N. Interruption versus continuation of trabectedin in patients with soft-tissue sarcoma (T-DIS): a randomised phase 2 trial. Lancet Oncol. 2015 Mar;16(3):312-9. doi: 10.1016/S1470-2045(15)70031-8. Epub 2015 Feb 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberta Sanfilippo, MD principal investigator
Fondazione IRCCS INT di Milano
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trabectedin discontinuation and Trabectedin continuation in people with Leiomyosarcoma and Liposarcoma, run by Italian Sarcoma Group at 15 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time secondary resistance to Trabectedin (time frame: Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773510, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.