Primary high risk leiomyosarcoma or dedifferentiated liposarcoma of the retroperitoneum.
Conditions
Interventions
Patients in the standard arm (surgery alone) will undergo large en- bloc curative intent surgery will be performed within 4 weeks following randomization.
Patients in the experimental arm will receiv
Sponsors
OZAKI Toshifumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis (LPS: Grade 3 DDLPS OR confirmed Grade 2 DDLPS on biopsy only if FNCLCC score = 5 AND clear necrosis on imaging. LMS: Any grade and size > 5 cm) * Unifocal tumour * Resectable tumour * Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by imaging within the 28 days prior to randomization. * Collection of tumor tissue and blood samples for central pathology review and translational research are mandatory. * >= 18 years old (no upper age limit) * WHO performance status * Patients with histologically proven primary resectable localized high-risk DDLPS or LMS of retroperitoneal space or infra-peritoneal spaces of pelvis (as described in the inclusion criteria of STRASS 2) and amenable to receive chemotherapy but for whom the list of eligibility criteria for the study is too restrictive. * Patients who meet all eligibility criteria of STRASS 2 but do not consent to randomization or are not enrolled for any other reason. * Patients enrolled in a Registry collecting data on primary RPS patients in the centres participating in STRASS 2 (e.g., RESAR) and who satisfy the above criteria.
Exclusion criteria
Exclusion criteria: * Sarcoma originating from bone structure, abdominal or gynecological viscera * Extension through the sciatic notch or across the diaphragm (excluding diagnostic biopsy) * Tumors for which histological grading cannot be determined by biopsy (excluding leiomyosarcoma) * Metastatic disease * Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour * Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients * Congestive heart failure * Angina pectoris * Myocardial infarction within 1 year before randomization * Uncontrolled arterial hypertension defined as blood pressure >= 150/100 mm Hg despite optimal medical therapy * Uncontrolled cardiac arrhythmia * Previous treatment with maximum cumulative doses (450mg/m2 Doxorubicin or equivalent 900mg/m2 Epirubicin) 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 Gleason <= 6prostate cancer. * Uncontrolled severe illness, infection, medical condition (including but not limited to uncontrolled diabetes and recent thromboembolic event in dose adjustments of the anticoagulation), 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| * Overall survival * Recurrence free survival * Distant metastases free survival * Cumulative incidence of local recurrences * Cumulative incidence of distant metastases * Radiological response to neoadjuvant chemotherapy according to RECIST * Radiological response to neoadjuvant chemotherapy according to CHOI * Pathological response * Safety and toxicity of neoadjuvant chemotherapy * Perioperative complications * Late complications * Health-Related Quality of life (EORTC QLQ-C30 + Item list from QLQ-STO22) * Health utility, calculated from the collected patient-reported HRQoL data and patient demographics economics | — |
Countries
Australia, Canada, Cyprus, Czechia, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactTomohiro FUJIWARA
Okayama University Hospital
Outcome results
None listed