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.
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
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
Parallel
Surgery
Procedure/SurgeryLarge en-bloc curative-intent surgery
Preoperative chemotherapy
Drug* 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.
Disease free survival
Disease free survival will be measured from the date of randomization (as reference) to the date of recurrence or death, whichever occurs first.
Overall survival (OS)
OS will be measured from the date of randomization to the date of death, whatever the cause. Alive patients will be censored at the date of last follow-up.
Recurrence free survival
Recurrence free survival will be measured in patients who were successfully operated (R0/R1 resection) from the date of surgery (as reference) to the date of recurrence (local or distant) or death, whichever occurs first. Patients without one of these events will be censored at the date of last follow-up.
Distant metastases free survival
Distant metastases free survival will be from the date of randomization (as reference) to the date of distant metastases or death (whatever the cause), whichever occurs first. Patients without any of these events will be censored at the date of last follow-up.
Cumulative incidence of local recurrences
Cumulative incidence of local recurrences will be measured from the date of randomization (as reference) to the date of local recurrence.
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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