Experimental arm for Retroperitoneal Sarcoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Retroperitoneal Sarcoma+2 MorePreoperative chemotherapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Retroperitoneal Sarcoma
  • Leiomyosarcoma
  • Liposarcoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 8 years from first patient in

Year 7
Disease free survival
Year 8
Distant metastases free survival
Local recurrence free survival
Overall survival (OS)
Recurrence free survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Experimental arm
1 of 1

Experimental Treatment

250 Total Participants · 1 Treatment Group

Primary Treatment: Experimental arm · No Placebo Group · Phase 3

Experimental arm
Drug
Experimental Group · 1 Intervention: Preoperative chemotherapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 years from first patient in

Who is running the clinical trial?

European Organisation for Research and Treatment of Cancer - EORTCLead Sponsor
401 Previous Clinical Trials
155,136 Total Patients Enrolled
Anticancer Fund, BelgiumOTHER
14 Previous Clinical Trials
1,566 Total Patients Enrolled
Eastern Cooperative Oncology GroupNETWORK
268 Previous Clinical Trials
149,765 Total Patients Enrolled
Australia and New Zealand Sarcoma AssociationUNKNOWN
Canadian Cancer Trials GroupNETWORK
114 Previous Clinical Trials
65,665 Total Patients Enrolled
Winan van HoudtStudy ChairThe Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Alessandro GronchiStudy ChairFondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 Previous Clinical Trials
12 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are diagnosed with high-risk leiomyosarcoma or liposarcoma in the retroperitoneal space, or infra-peritoneal spaces of the pelvis.
Any learning management system grade can be included.
The size of your LMS tumor must be at least 5 cm.
MDM2 and CDK4 expression should be confirmed through IHC, with MDM2 amplification highly recommended.
All Grade 3 Deep Lingual Papillae are eligible.
The grade 2 DDLPS has a FNCLCC score of five, no necrosis on biopsy but visible necrosis through imaging.
Your tumors possess a CINSARC-high gene profile, which is associated with increased risk.
Representative samples of either formalin-fixed, paraffin-embedded tumor blocks or unstained tissue slides must be present at the start for histological central assessment.
The tumor has not extended through the sciatic notch or across the diaphragm.
Pre-operative imaging (CT-abdomen, potentially also with MRI) is used to determine resectability of the tumor