Actively Recruiting
Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients
Led by Grupo Espanol de Investigacion en Sarcomas · Updated on 2023-05-31
199
Participants Needed
17
Research Sites
708 weeks
Total Duration
On this page
Sponsors
G
Grupo Espanol de Investigacion en Sarcomas
Lead Sponsor
C
Centre Leon Berard
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older.
- Diagnosis of specific soft tissue sarcoma types including liposarcoma, myxoid liposarcoma, leiomyosarcoma, and related subtypes.
- Tumor must be measurable and meet criteria for resectability or metastatic status according to cohort.
- Disease distribution must allow for safe delivery of radiotherapy.
- Performance status 0-1 (ECOG).
- Adequate bone marrow, respiratory, cardiac, and liver function.
- Negative pregnancy test for women of childbearing potential; effective contraception required.
- Central venous catheter must be in place for treatment administration.
- Limited prior chemotherapy allowed depending on cohort.
- Signed informed consent form before study procedures.
You will not qualify if you...
- Previous treatment with trabectedin or prior radiotherapy that conflicts with study treatment.
- Performance status 2 or higher (ECOG).
- Elevated bilirubin or creatinine beyond specified limits.
- Recent other cancers within 5 years except certain treated skin or cervical cancers.
- Severe pulmonary or cardiovascular diseases.
- Significant systemic diseases grade 3 or higher limiting availability or increasing toxicity risk.
- Uncontrolled infections including HIV.
- Pregnant or breastfeeding women.
- Psychological, social, or geographic issues limiting protocol compliance.
- Participation in another clinical trial or investigational treatment within 30 days prior to inclusion.
- Histologies not specified in inclusion criteria.
- Presence of metastases or lymph node involvement in certain cohorts.
- Unresectable tumors or location not meeting study criteria depending on cohort.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Institut Bergonié
Bordeaux, France, 33000
Actively Recruiting
2
Centre Léon Berard
Lyon, France
Actively Recruiting
3
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Not Yet Recruiting
4
Centro di Referimento Ocologico
Aviano, Italy, 33081
Not Yet Recruiting
5
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Not Yet Recruiting
6
Candiolo Cancer Institute
Candiolo, Italy, 10060
Actively Recruiting
7
Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
8
Hospital Miguel Servet
Zaragoza, Aragon, Spain, 50009
Actively Recruiting
9
Hospital Sant Pau
Barcelona, Catalonia, Spain, 08041
Actively Recruiting
10
Hospital Son Espases
Palma de Mallorca, Mallorca, Spain, 07010
Actively Recruiting
11
Hospital Universitario Canarias
San Cristóbal de La Laguna, Tenerife, Spain, 38320
Actively Recruiting
12
Hospital Vall d'Hebrón
Barcelona, Spain, 08035
Actively Recruiting
13
Hospital Puerta de Hierro
Madrid, Spain, 28006
Actively Recruiting
14
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
15
Hospital Uniersitario La Paz
Madrid, Spain, 28046
Actively Recruiting
16
Jiménez Díaz Foundation University Hospital
Madrid, Spain
Actively Recruiting
17
Hospital Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
Research Team
A
Adriana Rojo
CONTACT
E
Elisa Cerezo, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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