Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008/1485 | Other Identifier | CSET number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin, ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in first line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of soft tissue.
The trabectedin is a new cancer drug that has obtained marketing authorization after failure of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe. It has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.
This study aims to evaluate the usefulness of the combination of trabectedin with doxorubicin in first-line treatment of uterine or soft tissue leiomyosarcoma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soft tissue | Experimental |
| |
| Uterus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxorubicin | Drug | 60 mg/m² |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | Disease control rate (objective response + stability) as defined by RECIST criteria | Assessed every 6 weeks from inclusion up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Assessed using RECIST criteria | Assessed every 6 weeks from inclusion up to 6 months |
| Progression Free Survival | Assessed every 6 weeks from inclusion up to 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy Cancer Campus Grand Paris | Villejuif | Val de Marne | 94805 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34325109 | Derived | Pautier P, Floquet A, Chevreau C, Penel N, Guillemet C, Delcambre C, Cupissol D, Selle F, Isambert N, Piperno-Neumann S, Saada-Bouzid E, Bertucci F, Bompas E, Alexandre J, Collard O, Lebrun-Ly V, Soulier P, Toulmonde M, Le Cesne A, Lacas B, Duffaud F; French Sarcoma Group. A single-arm multicentre phase II trial of doxorubicin in combination with trabectedin in the first-line treatment for leiomyosarcoma with long-term follow-up and impact of cytoreductive surgery. ESMO Open. 2021 Aug;6(4):100209. doi: 10.1016/j.esmoop.2021.100209. Epub 2021 Jul 26. | |
| 25795402 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D000077606 | Trabectedin |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Trabectedin | Drug | 1,1 mg/m² |
|
|
| Derived |
| Pautier P, Floquet A, Chevreau C, Penel N, Guillemet C, Delcambre C, Cupissol D, Selle F, Isambert N, Piperno-Neumann S, Thyss A, Bertucci F, Bompas E, Alexandre J, Collard O, Lavau-Denes S, Soulie P, Toulmonde M, Le Cesne A, Lacas B, Duffaud F; French Sarcoma Group. Trabectedin in combination with doxorubicin for first-line treatment of advanced uterine or soft-tissue leiomyosarcoma (LMS-02): a non-randomised, multicentre, phase 2 trial. Lancet Oncol. 2015 Apr;16(4):457-64. doi: 10.1016/S1470-2045(15)70070-7. Epub 2015 Mar 18. |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |