Clinical Trial 22294

• Overview

  Study Title:

  A Randomized Phase III Study of Neoadjuvant Chemotherapy followed by Surgery versus Surgery Alone for Patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)

  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.

  Objective:

  Main objective: * The primary objective of this study is to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS and LMS patients as measured by disease free survival. Secondary objectives: * To assess whether there is a difference in the overall survival, recurrence free survival, distant metastases free survival, cumulative incidence of local recurrences and cumulative incidence of distant metastases between patients undergoing curative-intent surgery alone and those undergoing preoperative chemotherapy followed by curative intent surgery * To assess tumour response in patients undergoing preoperative chemotherapy * To assess the toxicity profile of preoperative chemotherapy given as "neoadjuvant" treatment to curative intent surgery in patients with RPS, and of * To assess whether there is a difference in quality of life between patients undergoing curative-intent surgery alone and those undergoing preoperative chemotherapy followed by curative intent surgery

• Treatments

  Therapies:

  Chemotherapy (NOS); Surgery

  Medications:

  Adriamycin (doxorubicin); DTIC (Dacarbazine); Dacarbazine (); Ifosfamide (); Not Applicable (); doxorubicin ()

• Inclusion Criteria

  • Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.
  • Representative formalin fixed, paraffin embedded tumor blocks or unstained tissue slides must be available at baseline for histological central review.
  • Unifocal tumor
  • Absence of extension through the sciatic notch or across the diaphragm
  • Resectable tumor: resectability is based on pre-operative imaging (CT-abdomen, potentially also with MRI) and has to be defined by the local treating sarcoma team. A patients is not considered resectable when the expectation is that only an R2 resection is feasible.
  • Tumor not previously treated (no previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy)
  • Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by imaging within the 28 days prior to randomization.
  • >18 years old (No upper age limit)
  • WHO performance status > Adequate organ function defined by protocol
  • American Society of Anesthesiologist score > Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment or surgery.
  • Additional criteria will apply

• Exclusion Criteria

  • Sarcoma originated from bone structure, abdominal or gynecological viscera
  • Metastatic disease
  • Tumors with extension through the sciatic notch or across the diaphragm
  • Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients
  • Persistent myelosuppression
  • Myocardial infarction within the last 6 months
  • Uncontrolled cardiac arrhythmia
  • Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
  • Active and uncontrolled infections
  • Vaccination with live vaccines within 30 days prior to study entry
  • Inflammation of the urinary bladder (interstitial cystitis) and/or obstructions of the urine flow.
  • Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer.
  • Uncontrolled severe illness, infection,medical condition (including, uncontrolled diabetes or hypertension), other than the Primary LPS or LMS of the retroperitoneum.
  • Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control method.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
  • Known contraindication to imaging tracer and to MRI

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