Tests trabectedin with radiotherapy in people with soft tissue sarcoma

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with soft tissue sarcoma in the retroperitoneum that can be removed by surgery. It tests trabectedin together with radiotherapy.

Age

Between 18 and 75 years.

Sex

Men and women can join.

Disease stage

Cohorts C and D: sarcoma in the retroperitoneum that can be removed by surgery, with no spread to lymph nodes or other organs. Cohort C: high grade leiomyosarcoma, or liposarcoma with at least 30% dedifferentiated tumour, or pleomorphic liposarcoma. Cohort D: well differentiated liposarcoma, or G2 dedifferentiated liposarcoma with less than 30% dedifferentiated tumour. The disease must be measurable. ECOG performance status 0–1. Cohorts A and B are described in the protocol.

Earlier treatment

No earlier chemotherapy for cohort C. Cohort D may have had one earlier line of chemotherapy, but not trabectedin. No earlier surgery or radiotherapy of the tumour. A central venous catheter is needed.

Biomarker or test result

Blood counts, kidney, liver and heart function (LVEF 50% or more) must be adequate. Hepatitis B and C tests must be done before joining.

Main reasons for not taking part

• Tumour that cannot be removed by surgery, or located outside the retroperitoneum
• Metastases or lymph node involvement
• Another cancer in the last 5 years, with few exceptions
• Known HIV-positive, or uncontrolled infection
• Pregnant or breast-feeding women

What the trial wants to find out

To determine the maximum tolerated dose (MTD) or the recommended phase II dose of trabectedin for the combination with radiation therapy. The safety profile for each cohort and dose level of trabectedin will be determined in order to find the recommended dose for phase II part in a specific way for each cohort of treatment. Adverse effects will be collected following the CTCAE 4.03 and they will be used as a rule for escalating or diminishing dose-levels regarding the dose-limiting toxicities detailed within the protocol. For Phase II the main objective was as follows: - RECIST response for the combination of trabectedin plus radiation o therapy in cohorts A, B. - CHOI response for the combination of trabectedin plus radiation therapy in cohort C. - In cohort D to improve 5-year relapse-free survival (RFS), decreasing the 5-year relapse percentage from 30% to 10% in patients with well differentiated liposarcoma with cellular component and dedifferentiated G2 retroperitoneal resected liposarcoma (20% increase in RFS).