EORTC-1809-STBSG: A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505261-84-00

Acronym

EORTC-1809-STBSG

Enrollment

180

Registered

2023-08-31

Start date

2020-10-06

Completion date

Unknown

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary high risk leiomyosarcoma or liposarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis

Brief summary

Disease free survival (which includes as events: distant progression on neoadjuvant treatment, local progression if not followed by R0/R1 surgery, non-operable tumours, local recurrence and/or distant metastases, R2 and death)

Detailed description

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.

Interventions

DRUGDACARBAZINE

DRUGIFOSFAMIDE

DRUGEPIRUBICIN HYDROCHLORIDE

DRUGDOXORUBICIN HYDROCHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease free survival (which includes as events: distant progression on neoadjuvant treatment, local progression if not followed by R0/R1 surgery, non-operable tumours, local recurrence and/or distant metastases, R2 and death)	—

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.	—

Measure

Time frame

—

Countries

Cyprus, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026