Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges.
Ralph Vatner, Charles D James, Vythialingam Sathiaseelan...
https://pubmed.ncbi.nlm.nih.gov/32827353Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID02275286
Phase I-II Prospective Trial Exploring Trabectedin Plus Radiotherapy for Soft Tissue Sarcoma Patients
Led by Grupo Espanol de Investigacion en Sarcomas · Updated on 2023-05-31
199
Participants Needed
17
Research Sites
N/A
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
Researchers are investigating the combination of trabectedin and radiotherapy to reduce tumors in patients with various types of soft tissue sarcoma. This Phase I-II trial evaluates different doses of trabectedin alongside specified radiation doses to measure tumor shrinkage and survival outcomes. The study includes four patient groups based on sarcoma type and tumor location, with cohorts A and B closed to new participants since 2023. The treatment involves intravenous trabectedin given over 24 hours every three weeks at doses of 1.3 or 1.5 mg/m2, combined with radiotherapy delivered in fractions ranging from 30 Gy to 45 Gy depending on the patient cohort. Cohort A patients may receive unlimited chemotherapy cycles, while cohorts B and C receive three cycles. Radiotherapy schedules vary by group, and a translational substudy examines biomarkers to predict treatment response. Participants undergo regular tumor imaging with CT and MRI scans, clinical evaluations, and quality of life questionnaires over months to years. Tumor responses are assessed every 6 weeks or 4 months depending on cohort, and safety is monitored through adverse event tracking every 21 days. Survival and relapse outcomes are followed for up to five years. Centralized pathology and radiology reviews support treatment decisions, and all participants must have a central venous catheter for chemotherapy delivery.
CONDITIONS
Brief Title
Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosed with specific types of soft tissue sarcoma as defined per cohort
- Tumor must be resectable or limited to lung metastases depending on the cohort
- Disease distribution allows safe radiation therapy as confirmed by radiation oncologist
- Measurable disease according to RECIST or Choi criteria
- Performance status ECOG 0-1
- Adequate respiratory, bone marrow, liver, kidney, and cardiac function
- Negative pregnancy test and use of effective contraception if of childbearing potential
- Central venous catheter for treatment
- No prior trabectedin treatment
- No uncontrolled infections or significant systemic diseases
- Signed informed consent before study procedures
You will not qualify if you...
- Prior treatment with trabectedin or radiotherapy that conflicts with study protocol
- Performance status ECOG 2 or higher
- Elevated bilirubin or creatinine beyond specified limits
- History of other cancer within 5 years (except certain treated cases)
- Severe pulmonary or cardiovascular disease
- Uncontrolled infections including HIV
- Pregnant or breastfeeding women
- Participation in another clinical trial or investigational treatment within 30 days
- Psychological or social circumstances limiting compliance
- Tumors unresectable or not fitting cohort-specific criteria
- Presence of metastases beyond allowed sites or lymph node involvement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 9 weeks for 3 cycles or longer for unlimited cycles depending on cohort
Participants receive trabectedin chemotherapy via 24-hour intravenous infusion every 3 weeks combined with radiotherapy. Radiotherapy doses vary by cohort, ranging from 30Gy in 10 fractions to 45Gy in 25 fractions.
Weekly visits for treatment and assessments during active therapy
Follow-up
Duration - Up to 24 months with extended survival follow-up up to 5 years
Participants are monitored for tumor response, adverse events, survival, and quality of life after treatment completion.
Visits every 3 months for up to 24 months and periodic assessments up to 5 years
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
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Research Team
A
Adriana Rojo
E
Elisa Cerezo, MSc
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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Published Research Related To This Trial
Assessment of Safety and Efficacy of Combined Trabectedin and Low-Dose Radiotherapy for Patients With Metastatic Soft-Tissue Sarcomas: A Nonrandomized Phase 1/2 Clinical Trial.
Javier Martin-Broto, Nadia Hindi, Antonio Lopez-Pousa...
https://pubmed.ncbi.nlm.nih.gov/32077895Trabectedin and RAdiotherapy in Soft Tissue Sarcoma (TRASTS): Results of a Phase I Study in Myxoid Liposarcoma from Spanish (GEIS), Italian (ISG), French (FSG) Sarcoma Groups.
Alessandro Gronchi, Nadia Hindi, Josefina Cruz...
https://pubmed.ncbi.nlm.nih.gov/31143880