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LiposarcomaPhase 2TRAVELLNCT02247544

Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma

A Phase 2 study testing Trabectedin in people with Liposarcoma and Leiomyosarcoma, run by Italian Sarcoma Group at 21 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an Italian, multicentre, single arm, phase II study, with an intra-patient comparison end point. This study aims at confirming the activity of the drug trabectedin as second/further line treatment in retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma expressed in terms of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liposarcoma, Leiomyosarcoma
What is being tested?
Trabectedin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
21 sitesItaly
Study dates
Mar 2014to 12 Mar 2019
Phase
Phase 2
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

  • Persistent or locally relapsed and/or metastatic disease (in case of local disease, surgery may be technically feasible or not, but the clinical judgment must be that medical therapy is indicated)
  • Pathology specimens available for centralized review
  • Age ≥ 18 years
  • European Eastern Cooperative Oncology Group Personal Status (ECOG PS) ≤ 2
  • One or more previous systemic treatments employing anthracyclines and ifosfamide (unless one or both are clinically contraindicated)
  • Measurable disease, as defined by Response Evaluation Criteria In Solid Tumors (RECIST)
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  • A minimum of 3 weeks since any previous medical therapy
  • Recovery from toxic effects of prior therapies to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 1 or lower
  • Adequate haematological, renal and liver functions
  • Ability and willingness to provide informed consent

Who cannot join

  • Pregnant or breast-feeding women
  • Prior exposure to trabectedin
  • Peripheral neuropathy, Grade 2 or higher
  • History of other malignancies (except for basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 years or more and judged of negligible potential of relapse
  • Known central nervous system (CNS) metastases
  • Active viral hepatitis or chronic liver disease
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  • Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias
  • Active major infection
  • Other serious concomitant illnesses

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Italy21 sites

  • Centro di Riferimento Oncologico di Aviano

    Aviano, PD, 33081

  • Istituto Tumori Giovanni Paolo II

    Bari, BA, 70124

  • Azienda Ospedaliera Giovanni Paolo XXIII

    Bergamo, BG, 24127

  • Azienda Ospedaliera S. Orsola-Malpighi

    Bologna, BO, 40138

  • A.O. Spedali Civili

    Brescia, BS, 25123

  • Ospedale Oncologico A. Businco

    Cagliari, CA, 09122

  • Istituto per la Ricerca e la Cura del Cancro di Candiolo

    Candiolo, TO, 10060

  • Azienda Ospedaliera Sant'Anna

    Como, CO, 22020

  • Azienda Ospedaliera S Croce e Carle

    Cuneo, CN, 12100

  • IRST IRCCS Meldola

    Meldola, FC, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI, 20133

  • Istituto Europeo di Oncologia

    Milan, MI, 20141

  • Istituto Nazionale Tumori - IRCCS - Fondazione Pascale

    Naples, 80131

  • Istituto Oncologico Veneto

    Padova, PD, 35128

  • Azienda Ospedaliera Universitaria Paolo Giaccone

    Palermo, PA, 90127

  • Azienda Ospedaliera Universitaria Santa Chiara

    Pisa, PI, 56124

  • Ospedale Misericordia e Dolce

    Prato, PO, 59100

  • Policlinico Universitario Campus Biomedico

    Roma, RM, 00128

  • Istituto Clinico Humanitas

    Rozzano, MI, 20089

  • Azienda Ospedaliera Santa Maria

    Terni, TR, 05100

  • Ospedale Gradenigo

    Torino, TO, 10153

Other trials in Italy

About this study

Official title: A Phase II Study on Trabectedin in Advanced Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma

This is an Italian, multicentre, single arm, phase II study, with an intra-patient comparison end point. This study aims at confirming the activity of the drug trabectedin as second/further line treatment in retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma expressed in terms of slowing down tumour growth.

Another objective is to investigate this peculiar benefit of trabectedin in typical retroperitoneal sarcomas may be exploited to help multidisciplinary clinical decision-making in the management of retroperitoneal sarcomas

Read the detailed description

Retroperitoneal soft-tissue sarcomas (R-STSs) are rare neoplasms, accounting for 10% to 15% of Soft Tissue Sarcomas (STSs), which represent 1-3% of all cancers. They may show different histological types, but the predominant ones in the retroperitoneal region are: leiomyosarcoma, liposarcoma. The most commonly encountered in the retroperitoneum is the well differentiated/dedifferentiated liposarcoma.

First-line chemotherapy usually consists of doxorubicin and/or ifosfamide. These two drugs are the most active agents in adult STSs, with a dose-response relationship and response rates between 20% and 50%. However, the sarcoma community is currently doubtful as to the activity of ifosfamide in the subgroup of leiomyosarcomas.

Trabectedin has been found to be mainly active in leiomyosarcoma and liposarcoma and is approved by European Medicines Agency (EMA) as second-line chemotherapy for STSs. Although the response rate observed in pre-registration studies did not exceed 10%, trabectedin provided disease control, with progression arrest rates exceeding 50% and Progression Free Survival (PFS) rates exceeding 20% at 6 months.

Since so far no phase II studies tested the activity of trabectedin in retroperitoneal sarcomas, this is the specific aim of this study.

Target population: Patients with previously treated, histologically confirmed, retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma. Patients may be either unamenable to surgery or amenable but in whom the addition of medical treatment is considered clinically advisable.

Translational studies will be performed, with the aim of characterising the tumour biological features associated with different response patterns to trabectedin. These assessments will be done in 15-20 patients who will undergo surgery after trabectedin, comparing tumour tissue specimens collected before and after treatment.

Being tested
Trabectedin
Keywords
STS, leiomyosarcoma, liposarcoma, trabectedin
Medical subject headings
Liposarcoma, Leiomyosarcoma, Ichthyosis, X-Linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrabectedinDrug

    Also called Yondelis

    Trabectedin administered at a dose of 1.5 mg/m2 - 1.3 mg/m2 (at investigator's discretion, with a top-dose of 2.6 total mg per cycle) as a 24-hour continuous infusion via a central venous access until progressive disease, major toxicity, patient's intolerance, unwillingness to continue treatment, or medical decision by the responsible physician

Study groups in NCT02247544
Study groupRoleWhat they receive
TrabectedinExperimentalTrabectedin will be administered intravenously at a dose of 1.5 mg/m2 or 1.3 mg/m2 (at investigator's discretion, with a top-dose of 2.6 total mg per cycle) as a 24-hour infusion once every 3 weeks (cycle day 1). Since trabectedin has no cumulative toxicities, treatment can be continued until progressive disease, major toxicity, patient's intolerance or unwillingness to continue treatment or medical decision by the responsible physician. In the subgroup of patients amenable to surgery, treatment will be reasonably continued until the best dimensional response.
Receives: Drug: Trabectedin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Growth Modulation Rate

    The primary end point of the study will be the proportion of responders to trabectedin, based on the ratio, in each single patient, between PFS under trabectedin (PFS) and time to progression after previous chemotherapy treatment (TTP1).

    Measured: From date of randomization until progressive disease, assessed up to 48 months

Secondary outcomes (6)

  1. Objective response (OR) in the overall sample

    Measured: From date of randomization until progressive disease, assessed up to 48 months

  2. Pathological tumour response in the two eligible histological types, in patients undergoing surgery after treatment

    Measured: From date of randomization until the best tumour dimensional response, assessed up to 48 months

  3. PFS and OR in the two eligible histological types

    Measured: From date of randomization until progressive disease, assessed up to 48 months

  4. PFS in patients who undergo surgery after, or during, medical therapy and those who do not

    Measured: From date of randomization until progressive disease, assessed up to 48 months

  5. Number of patients with grade>=3 adverse drug reactions, number of serious adverse events related to study drug and number of patients who will experience at least one serious adverse event

    Measured: From date of randomization until progressive disease, assessed up to 48 months

  6. Efficacy of trabectedin in reducing cancer related pain

    All patients will be administered a standardized questionnaire evaluating cancer related pain and use of antalgic medication.

    Measured: From date of randomization until progressive disease, assessed up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study startMar 2014
  3. Primary completion12 Mar 2019
  4. Study completion12 Mar 2019

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247544
Sponsor's protocol ID
ISG-STS-TRAB-2012
Other IDs
2012-005428-14
Acronym
TRAVELL
Status last verified
Oct 2021
First submitted
5 Sep 2014
Last updated
1 Nov 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trabectedin in people with Liposarcoma and Leiomyosarcoma, run by Italian Sarcoma Group at 21 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Growth Modulation Rate (time frame: From date of randomization until progressive disease, assessed up to 48 months). 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 NCT02247544.

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 1 Nov 2021.

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