Study comparing efficacy of doxorubicin with trabectedin followed by trabectedin in non-progressive patients versus doxorubicine alone as first-line therapy in patients with metastatic or unresectable leiomyosarcoma (uterine or soft tissue)

Randomised phase III multicentric study comparing efficacy of doxorubicin with trabectedin followed by trabectedin in non-progressive patients versus doxorubicine alone as first-line therapy in patients with metastatic or unresectable leiomyosarcoma (uterine or soft tissue) - LMS04

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002186-56-FR

Enrollment

Unknown

Registered

2016-10-20

Start date

2016-08-18

Completion date

Unknown

Last updated

2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Metastatic or Relapsed Unresectable Uterine or Soft Tissue Leiomyosarcoma MedDRA version: 19.0 Level: PT Classification code 10024191 Term: Leiomyosarcoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10046799 Term: Uterine leiomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: YONDELIS Product Name: trabectedin Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: TRABECTEDIN CAS Number: 114899-77-3 Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients must have histologically confirmed diagnosis of metastatic or or relapsed, unresectable uterine or soft tissue leiomyosarcoma, reviewed in a reference center (among RREPS network), previously untreated with chemotherapy , and with available Formalin Fixed Paraffin Embedded (FFPE) blocks 2. At least one measurable lesion according to RECIST V 1.1 criteria. Target could be in a previously irradiated field but has to be progressive or a biopsy had to be positive before inclusion. 3. Age = 18 years old 4. ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1. All other histological types of uterine sarcomas or soft tissue sarcomas 2. Any contraindication for the use of trabectedin and/or doxorubicin (cardiac, renal, hepatic, known hypersensitivity…) 3. History of another type of cancer not in complete remission for more than 3 years prior to study entry (except for cutaneous basal cell carcinoma or in situ cervical epithelioma), and/or having required any chemotherapy treatment at any time. 4. Known cerebral metastasis 5. History of allograft or autograft 6. Active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine and compare the progression-free survival (PFS) of patients treated in first line with doxorubicin alone or with the association of doxorubicin and trabectedin followed by trabectedin for non-progressive patients;Secondary Objective: Determine and compare for each arm : 1. Clinical benefice rate 2. Response rate 3. Duration of response 4. Toxicities. 5. Overall survival of patients 6. Progression-free survival in second line therapy (PFS2) after progression ;Primary end point(s): RECIST 1.1;Timepoint(s) of evaluation of this end point: At baseline, Every 6 weeks while on treatment period, Every 9 weeks while on maintenance period or follow up period.	—

Measure

Time frame

Main Objective: Determine and compare the progression-free survival (PFS) of patients treated in first line with doxorubicin alone or with the association of doxorubicin and trabectedin followed by trabectedin for non-progressive patients;Secondary Objective: Determine and compare for each arm : 1. Clinical benefice rate 2. Response rate 3. Duration of response 4. Toxicities. 5. Overall survival of patients 6. Progression-free survival in second line therapy (PFS2) after progression ;Primary end point(s): RECIST 1.1;Timepoint(s) of evaluation of this end point: At baseline, Every 6 weeks while on treatment period, Every 9 weeks while on maintenance period or follow up period.

—

Secondary

Measure	Time frame
Secondary end point(s): RECIST 1.1 NCI CTCAE Version 4;Timepoint(s) of evaluation of this end point: 1. 2. 3. At baseline and then every 6 weeks up to 6 cycles of treatment. 4. All along the study 5. All along the study until patient death (including long term follow-up) 6. All along the study until progression under second line therapy	—

Countries

France

Contacts

Public ContactService Promotion Etudes Cliniques

GUSTAVE ROUSSY

SPEC.Affaires.reglementaires@gustaveroussy.frFR +33142116198

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026