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Rhabdomyosarcoma Cohort Open for Accrual to SARC024 Regorafenib

Rhabdomyosarcoma Cohort Open for Accrual to SARC024 Regorafenib
SARC024 is a blanket protocol exploring the potential clinical benefit of regorafenib in several different subtypes of sarcoma.  Three cohorts or patient groups have completed accrual including osteosarcoma, lipsosarcoma and Ewing sarcoma.  Recently, a cohort to include patients with metastatic or recurrent rhabdomyosarcoma has been activated.  Eligible patients with metastatic or recurrent rhabdomyosarcoma and mesenchymal chondrosarcoma can be enrolled.  All patients enrolled will receive regorafenib.  For more details regarding this trial eligibility and centers that are enrolling patients click this link:  https://clinicaltrials.gov/ct2/show/NCT02048371 or contact the SARC office with any questions you may have: sarc@sarctrials.org or 734-930-7600
 
SARC024 IS OPEN FOR ACCRUAL to the Rhabdomyosarcoma and mesenchymal chondrosarcoma arms
FAQS FOR SARC024 – A blanket protocol to study oral regorafenib in patients with selected sarcoma subtypes. The study is currently open for patients with metastatic or recurrent rhabdomyosarcoma or mesenchymal chondrosarcoma.
  1. What is the purpose of this study? The purpose of this study is to learn if a drug called regorafenib when given to people with metastatic or recurrent sarcomas will provide clinical benefit, such as reduce tumor size or time to progression of disease. This trial is enrolling patients diagnosed with rhabdomyosarcoma and mesenchymal chondrosarcoma.
  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 not part of this clinical trial.
  4. What are the most common side effects related to Regorafenib? The most common side effects related to regorafenib are diarrhea, tiredness, decreased appetite, lowered ability to fight infection, swelling/redness in the mouth, stomach pain, weight loss, increase in certain liver function tests, and voice change or hoarseness.
  5. How long is treatment on this study? You would continue to receive regorafenib 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 Regorafenib, 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.