Phase I-II prospective trial, multicenter, open label, exploring the combination of Trabectedin plus RAdiotherapy in Soft Tissue Sarcoma patients
Key facts
- Where
- Barcelona, Madrid, Palma, San Cristóbal de La Laguna, Sevilla és Zaragoza, SpanyolországSee the 10 sites
- Phase
- 1/2. fázis
Where in Spanyolország
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországTaking people
- Hospital Universitario La PazMadrid, SpanyolországTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMadrid, SpanyolországTaking people
- University Hospital Son EspasesPalma, SpanyolországTaking people
- Hospital Universitario de CanariasSan Cristóbal de La Laguna, SpanyolországTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországTaking people
- Hospital Universitario Miguel ServetZaragoza, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Asoc Grupo Espanol De Investigacion En Sarcomas
- Trial code
- EU 2024-518199-30-00
- Record updated
- 2026. szeptember 4.
- Original description
To determine the maximum tolerated dose (MTD) or the recommended phase II dose of trabectedin for the combination with radiation therapy. The safety profile for each cohort and dose level of trabectedin will be determined in order to find the recommended dose for phase II part in a specific way for each cohort of treatment. Adverse effects will be collected following the CTCAE 4.03 and they will be used as a rule for escalating or diminishing dose-levels regarding the dose-limiting toxicities detailed within the protocol. For Phase II the main objective was as follows: - RECIST response for the combination of trabectedin plus radiation o therapy in cohorts A, B. - CHOI response for the combination of trabectedin plus radiation therapy in cohort C. - In cohort D to improve 5-year relapse-free survival (RFS), decreasing the 5-year relapse percentage from 30% to 10% in patients with well differentiated liposarcoma with cellular component and dedifferentiated G2 retroperitoneal resected liposarcoma (20% increase in RFS).Read full original descriptionShow less
To determine the maximum tolerated dose (MTD) or the recommended phase II dose of trabectedin for the combination with radiation therapy. The safety profile for each cohort and dose level of trabectedin will be determined in order to find the recommended dose for phase II part in a specific way for each cohort of treatment. Adverse effects will be collected following the CTCAE 4.03 and they will be used as a rule for escalating or diminishing dose-levels regarding the dose-limiting toxicities detailed within the protocol. For Phase II the main objective was as follows: - RECIST response for the combination of trabectedin plus radiation o therapy in cohorts A, B. - CHOI response for the combination of trabectedin plus radiation therapy in cohort C. - In cohort D to improve 5-year relapse-free survival (RFS), decreasing the 5-year relapse percentage from 30% to 10% in patients with well differentiated liposarcoma with cellular component and dedifferentiated G2 retroperitoneal resected liposarcoma (20% increase in RFS).