SOFT TISSUE & BONE SARCOMA GROUP

EORTC 1809 – STRASS 2/ STREXIT 2 – A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (RPS)

Retroperitoneal sarcoma is a very rare tumour, occurring in 0.5 to 1.0 per 100,000 of the population. Diagnosis and treatment are challenging. The standard of care consists currently of surgery. Overall patient survival at 5 years following surgery is between 60 and 70%.

The EORTC 1809 STRASS 2 study is the first official trial looking into potential benefits of chemotherapy before surgery to improve disease control and survival in patients burdened by this rare cancer. June 2023 signals the start of a new observational arm called STREXIT 2, attached to the ongoing clinical trial in order to capture real world data from patients who are not eligible to participate in STRASS 2.

The aim is to compare the clinical outcomes between STRASS 2 and STREXIT 2 and to explore the possible combination of STRASS 2 and matched STREXIT 2 patients. This will strengthen the results obtained from the randomised clinical trial data and increase the power of subgroup analyses.
The early incorporation of real-world data (STREXIT 2) into the trial (STRASS 2) will enrich the study population and provide a pragmatic approach to addressing crucial causal questions within a rare cancer population.

A positive outcome of the trial will help to understand the clinical added value and costs-effectiveness of neoadjuvant chemotherapy before surgery for high-risk retroperitoneal sarcoma. To determine the latter, a health economics analysis will be performed assessing the economic value of different treatment scenarios based on STRASS 2 and STREXIT 2.

Therefore, STRASS 2/STREXIT 2 study provides a unique opportunity to study the optimal treatment for retroperitoneal sarcoma patients with the possibility of changing clinical practice. This could lead to improved patient survival and quality of life but also improving health system sustainability. This is a multidisciplinary and multistakeholder consortium involving clinical oncologists, surgeons, health economists and patient representatives.

SOFT TISSUE & BONE SARCOMA GROUP

EORTC Cancer Research Fund

EORTC 1809 – STRASS 2/ STREXIT 2 – A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (RPS)

Retroperitoneal sarcoma is a very rare tumour, occurring in 0.5 to 1.0 per 100,000 of the population. Diagnosis and treatment are challenging. The standard of care consists currently of surgery. Overall patient survival at 5 years following surgery is between 60 and 70%.

The EORTC 1809 STRASS 2 study is the first official trial looking into potential benefits of chemotherapy before surgery to improve disease control and survival in patients burdened by this rare cancer. June 2023 signals the start of a new observational arm called STREXIT 2, attached to the ongoing clinical trial in order to capture real world data from patients who are not eligible to participate in STRASS 2.

The aim is to compare the clinical outcomes between STRASS 2 and STREXIT 2 and to explore the possible combination of STRASS 2 and matched STREXIT 2 patients. This will strengthen the results obtained from the randomised clinical trial data and increase the power of subgroup analyses.
The early incorporation of real-world data (STREXIT 2) into the trial (STRASS 2) will enrich the study population and provide a pragmatic approach to addressing crucial causal questions within a rare cancer population.

A positive outcome of the trial will help to understand the clinical added value and costs-effectiveness of neoadjuvant chemotherapy before surgery for high-risk retroperitoneal sarcoma. To determine the latter, a health economics analysis will be performed assessing the economic value of different treatment scenarios based on STRASS 2 and STREXIT 2.

Therefore, STRASS 2/STREXIT 2 study provides a unique opportunity to study the optimal treatment for retroperitoneal sarcoma patients with the possibility of changing clinical practice. This could lead to improved patient survival and quality of life but also improving health system sustainability. This is a multidisciplinary and multistakeholder consortium involving clinical oncologists, surgeons, health economists and patient representatives.

Clinical Trial

Clinical Trial Phase

Phase III

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Cancer type

EORTC Cancer Research Fund Cancer Type

Sarcoma

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Set up

Set-Up

EORTC & Intergroups

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Status

Status

Recruiting

Clinical trial:

Clinical Trial Phase

Phase III

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Cancer type:

EORTC Cancer Research Fund Cancer Type

Sarcoma

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Set up:

Set-Up

EORTC & Intergroups

Down Arrow

Status:

Status

Recruiting

KEY STUDY MILESTONES

KEY STUDY MILESTONES

A word from…

Study Coordinators
& Partners

Patients

A word from…

Study Co-ordinators & Partners

Patients

STUDY STATUS

PATIENT RECRUITMENT*

STRASS 2

STREXIT 2

*Latest update : June 2024

STUDY STATUS

Patient recruitment

*Updated December 2023

STUDY STATUS

To view the Study Status map, please flip your phone horizontally:

Video Series

STRASS2/STREXIT 2 – Introduction

Dr Winan van Houdt, introduces STREXIT2

Do you have any question on the EORTC STRASS 2/ STREXIT 2 clinical trial?

FUNDING PARTNERS

STRASS 2

International

National

EORTC Cancer Research Fund anticancerfund logo 500x190 2022 e1657713223361
Climbers Against Cancer
Sarcoma UK
Cancer Research UK
Novo Nordisk Fonden

STREXIT 2

European-Union-Funding-Logo

This research is funded under Horizon Europe funding program (project 101103843)

FUNDING PARTNERS

STRASS 2

International

EORTC Cancer Research Fund anticancerfund logo 500x190 2022 e1657713223361
Climbers Against Cancer

National

Sarcoma UK - Logo
Cancer Research UK
Novo Nordisk DK - Logo

STREXIT 2

European-Union-Funding-Logo

This research is funded under Horizon Europe funding program (project 101103843)