Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

199

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Liposarcoma, MyxoidSarcoma, Soft TissueLeiomyosarcomaLiposarcomaPleomorphic Liposarcoma
Interventions
DRUG

Trabectedin

"Escalating or deescalating dose of 1.3 or 1.5mg/m2, i.v 24h, once every 3 weeks.~Cohort A: unlimited cycles. Cohort B: 3 cycles. Cohort C: 3 cycles. Cohort D: cycles of trabectedin will be provided and patients will subsequently be evaluated for surgery."

RADIATION

Radiotherapy

3D conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT) providing: Cohort A: 30Gy in 10 fractions (3Gy/fraction). Cohort B: 45Gy in 25 fractions (1.8Gy/fraction). Cohort C: 45Gy in 25 fractions (1.8Gy/fraction). Cohort D: 45Gy in 25 fractions (1.8Gy/fraction).

Trial Locations (17)

10060

RECRUITING

Candiolo Cancer Institute, Candiolo

20089

NOT_YET_RECRUITING

Istituto Clinico Humanitas, Rozzano

20133

RECRUITING

Istituto Nazionale dei Tumori, Milan

28006

RECRUITING

Hospital Puerta de Hierro, Madrid

28007

RECRUITING

Hospital Universitario Gregorio Marañón, Madrid

28046

RECRUITING

Hospital Uniersitario La Paz, Madrid

33000

RECRUITING

Institut Bergonié, Bordeaux

33081

NOT_YET_RECRUITING

Centro di Referimento Ocologico, Aviano

38320

RECRUITING

Hospital Universitario Canarias, San Cristóbal de La Laguna

40136

NOT_YET_RECRUITING

Istituto Ortopedico Rizzoli, Bologna

41013

RECRUITING

Hospital Virgen del Rocío, Seville

50009

RECRUITING

Hospital Miguel Servet, Zaragoza

Unknown

RECRUITING

Centre Léon Berard, Lyon

RECRUITING

Jiménez Díaz Foundation University Hospital, Madrid

08041

RECRUITING

Hospital Sant Pau, Barcelona

07010

RECRUITING

Hospital Son Espases, Palma de Mallorca

08035

RECRUITING

Hospital Vall d'Hebrón, Barcelona

All Listed Sponsors
collaborator

Centre Leon Berard

OTHER

collaborator

Italian Sarcoma Group

NETWORK

lead

Grupo Espanol de Investigacion en Sarcomas

OTHER