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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.

Must not have

Sarcoma originated from bone structure, abdominal or gynecological viscera. Metastatic disease. Tumors with extension through the sciatic notch or across the diaphragm. Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients. Persistent myelosuppression. Myocardial infarction within the last 6 months. Uncontrolled cardiac arrhythmia. Previous treatment with maximum cumulative doses (450mg/m² Doxorubicin or equivalent 900mg/m² EpiADM) of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones. Active and uncontrolled infections. Vaccination with live vaccines within 30 days prior to study entry. Inflammation of the urinary bladder (interstitial cystitis) and/or obstructions of the urine flow. Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer. Uncontrolled severe illness, infection,medical condition (including, uncontrolled diabetes or hypertension), other than the Primary LPS or LMS of the retroperitoneum. Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control method. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial. Known contraindication to imaging tracer and to MRI.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 years from first patient in

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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).

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My LMS tumor is at least 5 cm in size.

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My cancer is a high-risk type of sarcoma in my lower abdomen or pelvis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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).