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Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients

ConditionsLiposarcoma, MyxoidSarcoma, Soft TissueLeiomyosarcomaLiposarcomaPleomorphic Liposarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGrupo Espanol de Investigacion en Sarcomas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Trabectedin

    Drug

    Escalating or deescalating dose of 1.3 or 1.5mg/m2, i.v 24h, once every 3 weeks. Cohort A: unlimited cycles. Cohort B: 3 cycles. Cohort C: 3 cycles. Cohort D: cycles of trabectedin will be provided and patients will subsequently be evaluated for surgery.

  • Radiotherapy

    Radiation

    3D conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT) providing: Cohort A: 30Gy in 10 fractions (3Gy/fraction). Cohort B: 45Gy in 25 fractions (1.8Gy/fraction). Cohort C: 45Gy in 25 fractions (1.8Gy/fraction). Cohort D: 45Gy in 25 fractions (1.8Gy/fraction).

Treatment groups

199 Participants
are divided into 1 treatment group
Group A: Trabectedin+RadiotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Tumor size

Image tumor assessment: RECIST response for the combination of trabectedin plus radiation therapy in cohorts A and B. CHOI response for the combination of trabectedin plus radiation therapy in cohort C.

Time frame
every 6 weeks for 24 months
2

Relapse-free survival.

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).

Time frame
5 years.

Secondary outcomes

1

Number and grade of adverse events

CTCAE v4.03 adverse events registration to evaluate safety

Time frame
every 21 days until 30 days after last dose or during 25 months
2

Number of months without progression

Progression free survival (PFS)

Time frame
24 months
3

Number of months alive

Overall survival (OS)

Time frame
24 months
4

Tumor size

Image tumor assessment measured by Choi criteria.

Time frame
every 6 weeks during 24 months (cohort A) or every 4months during 36 months (cohort B and C)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grupo Espanol de Investigacion en Sarcomas

Lead sponsor

Centre Leon Berard

Collaborator

Italian Sarcoma Group

Collaborator

Source ClinicalTrials.gov
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