Trial that evaluates the combination treatment of Trabectedin and Radiotherapy in Soft Tissue Sarcoma patients.

Phase I-II prospective trial, multicenter, open label, exploring the combination of Trabectedin plus Radiotherapy in Soft Tissue Sarcoma patients.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001549-26-ES

Enrollment

Registered

2014-10-03

Start date

2014-11-03

Completion date

Unknown

Last updated

2014-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Sarcoma

Interventions

Trade Name: YONDELIS 1 mg powder for concentrate for solution for infusion Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: TRABECTEDIN CAS Number: 114899-77-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria Cohort A - Aged between 18 and 70. - Patients must have a diagnostic of Soft Tissue Sarcoma with metastasis limited to lung, and not suitable for metatasectomy or surgery resection or not oncologically recommended metastasectomy - Patients must have documentation of disease progression within 6 months prior to study entry. - The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced/metastatic disease are allowed as long as trabectedin has not been included. - The following histological subtypes can be included: + Undifferentiated pleomorphic sarcoma (previously, malignant fibrous histiocytoma) + Leiomyosarcoma + Angiosarcoma/ epithelial hemangioendothelioma + Liposarcoma and its variants (well differentiated, dedifferentiated, myxoid/round cells, pleomorphic) + Synovial sarcoma + Fibrosarcoma and its variants (epithelial fibrosarcoma/low grade fibromyxoid sarcoma) + Hemangiopericytoma/solitary fibroid tumor + Neurogenic sarcoma (Malignant peripheral nerve sheath tumor, MPNST) + Myxofibrosarcoma + Epithelioid Sarcoma + Unclassified sarcoma (spindle cell/epithelioid/pleomorphic/myxoid) + Measurable disease, according to RECIST V 1.1 criteria + Adequate respiratory functions: FEV1 >1L - Adequate bone marrow function (hemoglobin > 10 g/dl, leukocytes ? 3.000/mm3, neutrophils ? 1.500/mm3, platelets ? 100.000/mm3). Patients with plasma creatinine ? 1,6 mg/dl, transaminases ? 2.5 times the UNL, total bilirubin ? UNL, CPK ? 2.5 times UNL, alkaline phosphatase ? 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is > 2.5 times the UNL, then the alkaline phosphatase liver fraction and/or 5? nucleotidase and/or GGT must be ? UNL. - Normal cardiac function with a LVEF ? 50% by echocardiogram or MUGA. - Disease distribution in lungs allows meeting with normal tissue constraints of radiation therapy. Radiation therapist must confirm this point. - Patient must have a Central Venous Catheter for treatment Cohort B - Aged between 18 and 70. - Pathological diagnosis of Myxoid Liposarcoma, deep located and more than 5 cm or superficial more than 10 cm. - Tumor must be resectable and without evidence of regional or distal spread after adequate staging procedure. Tumor must be located in limbs or superficial trunk wall. - Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation therapist must confirm this point. - Measurable disease, according to RECIST V 1.1 criteria - Adequate bone marrow function (hemoglobin > 10 g/dL, leukocytes ? 3.000/mm3, neutrophils ? 1.500/mm3, platelets ? 100.000/mm3). Patients with plasma creatinine ? 1,6 mg/dL, transaminases ? 2.5 times the UNL, total bilirubin ? UNL, CPK ? 2.5 times UNL, alkaline phosphatase ? 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is > 2.5 times the UNL, then the alkaline phosphatase liver fraction and/or 5? nucleotidase and/or GGT must be ? UNL. - Normal cardiac function with a LVEF ? 50% by echocardiogram or MUGA. - Patient may have had one previous chemotherapy line. - Patient must have a Central Venous Catheter for treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Cohort A - Previous treatment with trabectedin or radiotherapy involving any lung field. - Performance status ? 2 (ECOG). - Metastases out of those located in lungs. - Plasma bilirubin > UNL. - Creatinine > 1.6 mg/dL. - History of other neoplastic 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. - Uncontrolled bacterial, mycotic or viral infections. - Known positive test for infection by human immunodeficiency virus (HIV). - Women who are pregnant or breast-feeding. Cohort B 1. More than one previous chemotherapy treatment for local disease including trabectedin. 2. Radiotherapy involving the tumoral bed. 3. Performance status ? 2 (ECOG). 4. Presence of metastases or lymph node involvement by the tumor. 5. Location other than limb or superficial trunk wall. 6. Plasma bilirubin > UNL. 7. Creatinine > 1.6 mg/dL. 8. History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated. 9. Significant cardiovascular disease (for example, dyspnea > 2 NYHA) 10. 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. 11. Uncontrolled bacterial, mycotic or viral infections. 12. Known positive test for infection by human immunodeficiency virus (HIV). 13. Women who are pregnant or breast-feeding. 14. Psychological, familial, social or geographic circumstances that limit the patient?s ability to comply with the protocol or informed consent. 15. Patients participating in another clinical trial or receiving any other investigational product. 16. Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.

Design outcomes

Primary

Measure	Time frame
Main Objective: Cohort A (Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma), and Cohort B (Patients with locally advanced resectable Myxoid Liposarcoma) primary objective is response to treatment of the combination of trabectedin plus radiation therapy.;Timepoint(s) of evaluation of this end point: For phase I and II of cohort A, the imaging evaluation will be performed at baseline and every 6 weeks until disease progression. For phase I and II of cohort B, the imaging evaluation to assess response following RECIST criteria, will be performed at baseline, week 10 from starting treatment and at follow up: MRI every 4 months in 1st year, every 6 months during 2nd and 3rd year; Thorax/Abdo CT scan will be performed every 4 months during 3 years.;Primary end point(s): Evaluation of RECIST criteria;Secondary Objective: For Cohort A: - Toxicity profile - Efficacy response -CHOI criteria response - Quality of Life For Cohort B: - Toxicity profile -Activity -Efficacy -CHOI criteria response -Quality of life measured	—

Measure

Time frame

Main Objective: Cohort A (Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma), and Cohort B (Patients with locally advanced resectable Myxoid Liposarcoma) primary objective is response to treatment of the combination of trabectedin plus radiation therapy.;Timepoint(s) of evaluation of this end point: For phase I and II of cohort A, the imaging evaluation will be performed at baseline and every 6 weeks until disease progression. For phase I and II of cohort B, the imaging evaluation to assess response following RECIST criteria, will be performed at baseline, week 10 from starting treatment and at follow up: MRI every 4 months in 1st year, every 6 months during 2nd and 3rd year; Thorax/Abdo CT scan will be performed every 4 months during 3 years.;Primary end point(s): Evaluation of RECIST criteria;Secondary Objective: For Cohort A: - Toxicity profile - Efficacy response -CHOI criteria response - Quality of Life For Cohort B: - Toxicity profile -Activity -Efficacy -CHOI criteria response -Quality of life measured

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Secondary

Measure	Time frame
Secondary end point(s): Cohort A: - Assessment of adverse events following CTCAE v4.03 - Progression Free survival, Overall Survival, potential predictive/prognostic biomarkers. - CHOI criteria response - QLQ-C30 EORTC questionnaire Cohort B: -Assessment of adverse events following CTCAE v4.03 - Activity assessed by Functional imaging, pathologic response and potential predictive/prognostic biomarkers. -Recurrence free survival -CHOI criteria Response -QLQ-C30 EORTC questionnaire;Timepoint(s) of evaluation of this end point: - Adverse events will be evaluated at the beginning of each cycle prior to treatment, and end of treatment -For phase I and II of cohort A, the imaging evaluation will be performed at baseline and every 6 weeks until disease progression. For phase I and II of cohort B, the imaging evaluation to assess response following RECIST criteria, will be performed at baseline, week 10 from starting treatment and at follow up: MRI every 4 months in 1st year, every 6 months during 2nd and 3rd year; Thorax/Abdo CT scan will be performed every 4 months during 3 years. - tumor collection and blood extractions. -Questionnaires in cohort A will be done at baseline, and every 3 cycles until end of treatment; cohort B at baseline, week 10 from beginning of treatment and at end of treatment.	—

Measure

Time frame

Secondary end point(s): Cohort A: - Assessment of adverse events following CTCAE v4.03 - Progression Free survival, Overall Survival, potential predictive/prognostic biomarkers. - CHOI criteria response - QLQ-C30 EORTC questionnaire Cohort B: -Assessment of adverse events following CTCAE v4.03 - Activity assessed by Functional imaging, pathologic response and potential predictive/prognostic biomarkers. -Recurrence free survival -CHOI criteria Response -QLQ-C30 EORTC questionnaire;Timepoint(s) of evaluation of this end point: - Adverse events will be evaluated at the beginning of each cycle prior to treatment, and end of treatment -For phase I and II of cohort A, the imaging evaluation will be performed at baseline and every 6 weeks until disease progression. For phase I and II of cohort B, the imaging evaluation to assess response following RECIST criteria, will be performed at baseline, week 10 from starting treatment and at follow up: MRI every 4 months in 1st year, every 6 months during 2nd and 3rd year; Thorax/Abdo CT scan will be performed every 4 months during 3 years. - tumor collection and blood extractions. -Questionnaires in cohort A will be done at baseline, and every 3 cycles until end of treatment; cohort B at baseline, week 10 from beginning of treatment and at end of treatment.

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Countries

Spain

Contacts

Public ContactMelissa Fernández Pinto

GEIS

melissa.crc@grupogeis.org0034912866807

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026