Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients (NCT02275286) | Clinical Trial Compass
RecruitingPhase 1/2
Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients
France, Italy199 participantsStarted 2014-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient must sign voluntarily the informed consent form before any study test is conducted that is not part of routine patient care.
✓. Aged equal or over 18.
✓. Patients must have a diagnostic of Soft Tissue Sarcoma with metastasis limited to lung, and not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy.A centralized diagnostic will be performed, the tumor sample must be available and sent prior to inclusion.
✓. Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point.
✓. Metastatic spread could be present in two organs at maximum (i.e. lungs and pelvic fosa).
✓. Those lesions considered for radiation therapy have to be considered as target lesions as well. (i.e. in a patient with nodules in lungs, those lesions selected for radiation therapy have to include at least the target lesions)
✓. It is allowed that not all the lesions will be under radiation fields. As a general rule, it will be prioritized to select, as target-irradiating lesions, those with greater increase in size and those largest lesions. It should be discouraged to irradiate pulmonary lesions with infiltration of pleural serosa.
. Patients must have documentation of disease progression within 6 months prior to study entry.
Exclusion criteria
✕. Previous treatment with trabectedin or previous treatment with radiotherapy (except if previous radiotherapy treatment plus planned study radiotherapy treatment allow tissues constrains)
✕. Performance status ≥ 2 (ECOG).
✕. Plasma bilirubin \> UNL.
✕. Creatinine \> 1.6 mg/dL.
✕. History of other neoplastic disease with less than 5 years free of disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.
✕. Severe COPD or other severe pulmonary diseases.
✕. Significant cardiovascular disease (for example, dyspnea \> 2 NYHA)
✕. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.