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

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Soft Tissue Sarcoma

• Registration Number: EUCTR2014-001549-26-ES
• Lead Sponsor: GEIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-03
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 96

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified