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Preoperative Chemotherapy + Surgery for Sarcoma (STRASS2 Trial)
Phase 3
Recruiting
Research Sponsored by European Organisation for Research and Treatment of Cancer - EORTC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
LMS: Any grade LMS can be included. Minimum size of LMS tumor should be 5 cm.
Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years from first patient in
Awards & highlights
STRASS2 Trial Summary
This trialtests if chemo before surgery can help people with a certain type of cancer live longer.
Who is the study for?
This trial is for adults with high-risk leiomyosarcoma or liposarcoma in the retroperitoneal or pelvic spaces, who haven't had previous treatments. Tumors must be a certain size and meet specific criteria. Patients need to have good organ function, no severe illnesses, not be pregnant or breastfeeding, and agree to use effective birth control.Check my eligibility
What is being tested?
The study is testing if adding preoperative chemotherapy before surgery can improve disease-free survival for patients with high-risk sarcomas. Participants will be randomly assigned to either receive standard surgery alone (control group) or chemotherapy followed by surgery (experimental group).See study design
What are the potential side effects?
Potential side effects from the chemotherapy may include nausea, fatigue, hair loss, increased risk of infection due to lowered blood cell counts, heart problems like changes in heart rhythm or function, and allergic reactions to the drugs used.
STRASS2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My LMS tumor is at least 5 cm in size.
Select...
My cancer is a high-risk type of sarcoma in my lower abdomen or pelvis.
STRASS2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 years from first patient in
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years from first patient in
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease free survival
Secondary outcome measures
Distant metastases free survival
Local recurrence free survival
Overall survival (OS)
+1 moreSTRASS2 Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard armExperimental Treatment1 Intervention
Surgery alone
Group II: Experimental armExperimental Treatment1 Intervention
Preoperative chemotherapy and surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgery
2000
Completed Phase 3
~2550
Find a Location
Who is running the clinical trial?
Eastern Cooperative Oncology GroupNETWORK
268 Previous Clinical Trials
151,345 Total Patients Enrolled
European Organisation for Research and Treatment of Cancer - EORTCLead Sponsor
412 Previous Clinical Trials
164,834 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupNETWORK
116 Previous Clinical Trials
176,672 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis was confirmed with specific tests for MDM2 and CDK4.You have certain types of sarcoma that originated from bone, abdominal or gynecological organs, and it has spread to other parts of the body. You have a history of severe allergic reactions to certain medications used to treat sarcoma. You have experienced long-term suppression of your bone marrow. You have had a heart attack within the past 6 months. You have uncontrolled heart rhythm problems. You have already received the maximum allowed doses of certain chemotherapy drugs. You have active and uncontrolled infections. You have received live vaccines within the past month. You have bladder inflammation or blockage of urine flow. You have had another type of cancer within the past 5 years, except for certain types of skin, cervical, or prostate cancer that have been treated and cured. You have uncontrolled severe illness or medical conditions other than the specific type of sarcoma being studied. If you are a female patient, you are pregnant or breastfeeding, or if you are a male or female patient capable of having children, you are not willing to use effective birth control methods. You have any psychological, family, social, or geographical circumstances that could make it difficult for you to follow the study's instructions and schedule. You have known allergies to certain imaging agents and magnetic resonance imaging (MRI).I have a specific type of sarcoma (DDLPS) that is considered high risk but operable.My LMS tumor is at least 5 cm in size.My cancer is a high-risk type of sarcoma in my lower abdomen or pelvis.
Research Study Groups:
This trial has the following groups:- Group 1: Standard arm
- Group 2: Experimental arm
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for participators still available in this experiment?
"Indeed, the information on clinicaltrials.gov confirms that this trial is open and accepting participants. This research project was initially posted on January 20th 2021 and last updated on December 27th 2022; 250 volunteers are needed from two separate sites."
Answered by AI
How many participants are accepted into the clinical trial at this time?
"Affirmative. Clinicaltrials.gov data shows that this investigation, which was initially announced on January 20th 2021, is still recruiting individuals to participate. The clinical trial requires 250 participants from two medical centres."
Answered by AI
To what degree is the Experimental arm safe for human use?
"Our team has rated the safety of Experimental arm at a 3, indicating that there is existing clinical data substantiating its efficacy along with numerous reports validating its security."
Answered by AI
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