New Study in Ewing Sarcoma Open to Enrollment

January 15, 2021

SARC037 is a phase I study protocol to determine the recommended dose of trabectedin given as a 1-hour infusion in combination with low dose irinotecan. All patients enrolled will receive trabectedin combination with low does irinotecan. 

For more details regarding this trial eligibility and centers that are enrolling patients:  https://clinicaltrials.gov/ct2/show/NCT04067115 

Contact the SARC office with any questions you may have: sarc@sarctrials.org or 734-930-7600

SARC037 IS OPEN FOR ACCRUAL

FAQS FOR SARC037

The study is currently open for patients with relapsed and refractory Ewing sarcoma with EWS-FLI1 fusion type aged 10 years and older.

  1. What is the purpose of this study? The purpose of this study is to learn the recommended dose of a drug called trabectedin in combination with irinotecan for patients diagnosed with relapsed and refractory Ewing sarcoma. This study may also learn if when given to people with relapsed and refractory Ewing sarcoma will provide clinical benefit, such as reduce tumor size or time to progression of disease. This trial is enrolling patients diagnosed with relapsed and refractory Ewing sarcoma with EWS-FLI1 fusion type
  2. What is RECIST criteria? RECIST (Response Evaluation Criteria in Solid Tumors) is a commonly used standard to determine whether a patient’s tumor(s) is responding to therapy. Based on the change in the size of tumor(s) measured on CT, MRI or other radiology studies, physicians use RECIST to classify tumor response into different categories e.g. tumor is unchanged in size (stable), tumor is shrinking (partial response), tumor has disappeared (complete response), or tumor is growing (progression).
  3. Is biopsies part of this clinical trial? The biopsies are part of this clinical trial.
  4. What are the most common side effects related to Trabectedin? The most common side effects related to trabectedin are diarrhea, tiredness, decreased appetite, vomiting, constipation, swelling of the hands, ankles, and feet, shortness of breath, decreased red cells that carry oxygen in the blood, decreased platelets, and changes in results from liver and kidney function tests.
  5. How long is treatment on this study? You would continue to receive trabectedin until the progression of your disease, unacceptable side effects caused by study medicines, you choose to stop treatment, your doctor feels you should not continue on the study, you become pregnant or another illness prevents you from continuing on the study.
  6. Can I participate in a trial with my local doctor? In order to be treated in the clinical trial of Trabectedin in combination with Irinotecan, you must enroll and be treated at one of the designated approved oncology centers involved in this clinical trial. Please contact SARC at www.sarctrials.org to find the nearest center to you. For more information you can call or email SARC (sarc@sarctrials.org or 734-930-7600). This trial is also listed at: https://clinicaltrials.gov/ct2/show/NCT02048371
  7. Can patients from outside US participate? Patients from outside the US may participate in the trial but they must be evaluated, enrolled and treated by one of the approved oncology centers for this trial. Currently, only centers in the US are approved to conduct this trial.
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