NCT04031677

Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Standard arm: * Large en-bloc curative-intent surgery within 4 weeks following randomization- Experimental arm Experimental arm: * 3 cycles of neoadjuvant chemotherapy starting within 2 weeks following randomization: * High grade LPS: ADM (doxorubicin) 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m3 Q3 weeks. * LMS: ADM 75 mg/m2 + DTIC (dacarbazine) 1 g/m2 Q3 weeks * re-assessment of operability * curative-intent surgery within 3-6 weeks of last cycle of chemotherapy

Conditions

• Retroperitoneal Sarcoma
• Liposarcoma
• Leiomyosarcoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-20
• Primary completion: 2027-04-21
• Completion: 2028-04-21
• First posted: 2019-07-24
• Last updated: 2026-03-31

Locations

164 sites across 15 countries: United States, Australia, Canada, Cyprus, Czechia, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study