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Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

NCT04031677 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Retroperitoneal Sarcoma
  • Liposarcoma
  • Leiomyosarcoma

Interventions

PROCEDURE

Surgery

Large en-bloc curative-intent surgery

DRUG

Preoperative chemotherapy

* High grade LPS: ADM 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m2 Q3 weeks * LMS: ADM 75 mg/m2 + DTIC 1g/m2 Q3 weeks Note: the recommended dose of Doxorubicin (or Epirubicin) can be modified according to national/institutional guidelines, given that the minimal threshold must be Doxorubicin 60 mg/m2 per cycle (or the equivalent Epirubicin 95 mg/m2 per cycle); the recommended dose of Ifosfamide can be modified according to national/institutional guidelines, given that the minimal threshold must be 7.5 g/m2 per cycle; the recommended dose of Dacarbazine can be modified according to national/institutional guidelines, given that the minimal threshold must be 900 mg/m2 per cycle. The schedule of administration of above chemotherapies can be modified according to national/institutional guidelines provided that the minimal threshold of doses, and the treatment periods with chemotherapies remain the same.

Sponsors & Collaborators

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • ECOG-ACRIN Cancer Research Group

    collaborator NETWORK

  • Anticancer Fund, Belgium

    collaborator OTHER

  • Australia and New Zealand Sarcoma Association

    collaborator OTHER

  • Japan Clinical Oncology Group

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2027-04-21
Completion
2028-04-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Cyprus
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04031677 on ClinicalTrials.gov