Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma
TRAVELL
A Phase II Study on Trabectedin in Advanced Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma
2 other identifiers
interventional
105
1 country
21
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2014
Longer than P75 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 5, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2019
CompletedNovember 1, 2021
October 1, 2021
5 years
September 5, 2014
October 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
From date of randomization until progressive disease, assessed up to 48 months
Secondary Outcomes (6)
Objective response (OR) in the overall sample
From date of randomization until progressive disease, assessed up to 48 months
Pathological tumour response in the two eligible histological types, in patients undergoing surgery after treatment
From date of randomization until the best tumour dimensional response, assessed up to 48 months
PFS and OR in the two eligible histological types
From date of randomization until progressive disease, assessed up to 48 months
PFS in patients who undergo surgery after, or during, medical therapy and those who do not
From date of randomization until progressive disease, assessed up to 48 months
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
From date of randomization until progressive disease, assessed up to 48 months
- +1 more secondary outcomes
Study Arms (1)
Trabectedin
EXPERIMENTALTrabectedin 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Istituto Tumori Giovanni Paolo II
Bari, BA, 70124, Italy
Azienda Ospedaliera Giovanni Paolo XXIII
Bergamo, BG, 24127, Italy
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, BO, 40138, Italy
A.O. Spedali Civili
Brescia, BS, 25123, Italy
Ospedale Oncologico A. Businco
Cagliari, CA, 09122, Italy
Azienda Ospedaliera S Croce e Carle
Cuneo, CN, 12100, Italy
Azienda Ospedaliera Sant'Anna
Como, CO, 22020, Italy
IRST IRCCS Meldola
Meldola, FC, 47014, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, 20133, Italy
Istituto Europeo di Oncologia
Milan, MI, 20141, Italy
Istituto Clinico Humanitas
Rozzano, MI, 20089, Italy
Azienda Ospedaliera Universitaria Paolo Giaccone
Palermo, PA, 90127, Italy
Centro di Riferimento Oncologico di Aviano
Aviano, PD, 33081, Italy
Istituto Oncologico Veneto
Padua, PD, 35128, Italy
Azienda Ospedaliera Universitaria Santa Chiara
Pisa, PI, 56124, Italy
Ospedale Misericordia e Dolce
Prato, PO, 59100, Italy
Policlinico Universitario Campus Biomedico
Roma, RM, 00128, Italy
Istituto per la Ricerca e la Cura del Cancro di Candiolo
Candiolo, TO, 10060, Italy
Ospedale Gradenigo
Torino, TO, 10153, Italy
Azienda Ospedaliera Santa Maria
Terni, TR, 05100, Italy
Istituto Nazionale Tumori - IRCCS - Fondazione Pascale
Napoli, 80131, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo G. Casali, MD
IRCCS Fondazione Istituto Nazionale per la cura dei tumori di Milano
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2014
First Posted
September 25, 2014
Study Start
March 1, 2014
Primary Completion
March 12, 2019
Study Completion
March 12, 2019
Last Updated
November 1, 2021
Record last verified: 2021-10