Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

About this trial

This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.

After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

Eligibility criteria

Qualifiers

STRASS 2

Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.

Any grade LMS can be included

Minimum size of LMS tumor should be 5 cm

Disqualifiers

Sarcoma originating from bone structure, abdominal or gynecological viscera

Extension through the sciatic notch or across the diaphragm

Metastatic disease

Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour

Trial design

Treatments tested in this trial

  • Surgery
  • Preoperative chemotherapy

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Lead sponsor

Canadian Cancer Trials Group

Collaborator

ECOG-ACRIN Cancer Research Group

Collaborator

Anticancer Fund, Belgium

Collaborator

Australia and New Zealand Sarcoma Association

Collaborator

Japan Clinical Oncology Group

Collaborator