Surgery With or Without Pre-Surgery Chemotherapy for High Risk Retroperitoneal Sarcoma

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04031677

Provider View

This study is exploring whether adding chemotherapy before surgery can improve outcomes for patients with high-risk retroperitoneal sarcoma, a type of cancer in the abdominal area. Patients will be randomly assigned to receive either surgery alone or chemotherapy followed by surgery.

Patient Parameters

Program Overview

This clinical trial is investigating if giving chemotherapy before surgery can help improve the chances of staying cancer-free for patients with high-risk dedifferentiated liposarcoma (DDLPS) and leiomyosarcoma (LMS) in the abdominal area. After confirming eligibility, patients will be randomly assigned to either receive only surgery or chemotherapy followed by surgery.

Description

In this study, patients will be divided into two groups:

  • Standard Group:

    • Patients will undergo a large surgery aimed at removing the cancer within 4 weeks after being assigned to this group.

  • Experimental Group:

    • Patients will receive 3 cycles of chemotherapy before surgery, starting within 2 weeks after being assigned to this group. The chemotherapy will include:
      • For high-grade liposarcoma: Doxorubicin and Ifosfamide every 3 weeks.
      • For leiomyosarcoma: Doxorubicin and Dacarbazine every 3 weeks.
    • After chemotherapy, doctors will reassess if surgery is possible.
    • Surgery will be performed within 3-6 weeks after the last chemotherapy cycle.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-risk leiomyosarcoma (LMS) or liposarcoma (LPS) in the abdominal or pelvic area.
  • LMS can be of any grade, but the tumor must be at least 5 cm in size.
  • LPS must be confirmed by specific tests and meet certain criteria.
  • Tumor must be a single mass and removable by surgery based on imaging tests.
  • Must be 18 years or older.
  • Must have good overall health and organ function.
  • Women of childbearing potential must have a negative pregnancy test and use effective birth control during and after treatment.
  • Men in the experimental group must agree to use birth control and not donate sperm.
  • Must provide consent to participate in the study.

Exclusion Criteria

  • Sarcoma originating from bone or certain organs.
  • Cancer that has spread to other parts of the body.
  • Previous treatment for the current tumor.
  • Allergies to specific chemotherapy drugs.
  • Heart problems or uncontrolled high blood pressure.
  • Active infections or recent live vaccinations.
  • Other serious health conditions or cancers within the last 5 years.
  • Women who are pregnant or breastfeeding.
  • Inability to comply with study requirements or follow-up schedule.

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