Condition: Liposarcoma, Myxoid · Sarcoma, Soft Tissue · Leiomyosarcoma · Sponsor: Grupo Espanol de Investigacion en Sarcomas
Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in four cohorts of patients: Cohort A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma. Cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Cohort C: Patients with retroperitoneal and resectable soft tissue sarcoma (liposarcoma and leiomyosarcoma). Cohort D (Phase II only): Patients with well differentiated liposarcoma and G2 dedifferentiated liposarcoma (with less than 30% dedifferentiated component). Phase I: escalating dose of 1.3 or 1.5 mg/m2. Phase I for cohort C: de-escalating dose of 1.5 or 1.3mg/m2 Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction). Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction). Radiotherapy for cohort C: 45Gy in 25 fractions (1.8Gy/fraction). Radiotherapy for cohort D: 45Gy in 25 fractions (1.8Gy/fraction). A translational substudy is developed to analyse different biomarkers predictive value. Cohorts A and B are closed to recruitment in 2023.
This description comes directly from the study's public registry record.
Adriana Rojo · 0034912866807 · adriana.crc@grupogeis.org
Elisa Cerezo, MSc · 0034912866807 · elisa.crc@grupogeis.org
Always discuss trial participation with your own doctor first.
| Institut Bergonié | Bordeaux, France | Recruiting |
| Centre Léon Berard | Lyon, France | Recruiting |
| Istituto Clinico Humanitas | Rozzano, Milan, Italy | Not Yet Recruiting |
| Centro di Referimento Ocologico | Aviano, Italy | Not Yet Recruiting |
| Istituto Ortopedico Rizzoli | Bologna, Italy | Not Yet Recruiting |
| Candiolo Cancer Institute | Candiolo, Italy | Recruiting |
| Istituto Nazionale dei Tumori | Milan, Italy | Recruiting |
| Hospital Miguel Servet | Zaragoza, Aragon, Spain | Recruiting |
| Hospital Sant Pau | Barcelona, Catalonia, Spain | Recruiting |
| Hospital Son Espases | Palma de Mallorca, Mallorca, Spain | Recruiting |
| Hospital Universitario Canarias | San Cristóbal de La Laguna, Tenerife, Spain | Recruiting |
| Hospital Vall d'Hebrón | Barcelona, Spain | Recruiting |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT02275286