Study on Risk-Adapted Proton Beam Radiation and Surgery for Different Risk Levels of Rhabdomyosarcoma with Standard or Intensified Chemotherapy
Sponsor: St. Jude Children's Research Hospital
ClinicalTrials ID:NCT01871766
This clinical trial is exploring a treatment plan for patients with newly diagnosed rhabdomyosarcoma, a type of cancer, using a combination of chemotherapy, radiation, and surgery. The study aims to see if adding maintenance therapy can improve outcomes for those with intermediate and high-risk levels.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is designed to treat patients with newly diagnosed rhabdomyosarcoma (RMS) using a combination of chemotherapy, radiation, and surgery. Patients are grouped into low, intermediate, and high-risk categories based on their cancer's characteristics. Those in the intermediate and high-risk groups will receive additional maintenance therapy with anti-angiogenic chemotherapy to see if it improves their outcomes.
Description
Participants in this study will be divided into groups based on their cancer's risk level. Low-risk patients will receive chemotherapy and radiation. Some low-risk and all intermediate-risk patients may also have surgery to remove the tumor. Intermediate-risk patients will receive 16 weeks of additional maintenance chemotherapy. High-risk patients will receive chemotherapy, radiation, and extra maintenance therapy with anti-angiogenic chemotherapy. The study aims to improve survival rates and understand the side effects of these treatments.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with localized rhabdomyosarcoma (RMS).
- Must be classified as low, intermediate, or high-risk based on specific criteria.
- Low-risk: Certain types of tumors in specific stages and groups.
- Intermediate-risk: Certain types of RMS in specific stages and groups.
- High-risk: RMS with metastatic disease at diagnosis.
- Participants who progress to a higher risk level will switch to the high-risk treatment plan.
- Under 22 years old.
- Good overall health with a performance score of 0, 1, or 2.
- No prior treatment for rhabdomyosarcoma, except in emergencies.
- Chemotherapy planned within 6 weeks of biopsy or surgery.
- Adequate bone marrow, liver, and kidney function.
- Females of childbearing potential must not be pregnant or breastfeeding and must use contraception.
- No active, uncontrolled infections.
- Informed consent must be signed by participants or guardians.
Exclusion Criteria
- Participants who do not meet the inclusion criteria.
Inclusion Criteria for Contrast-Enhanced Ultrasound (CEUS) Sub-Study:
- Newly diagnosed or suspected rhabdomyosarcoma.
- Intermediate or high-risk disease.
- Aged 0-21 years.
Exclusion Criteria for CEUS Sub-Study:
- Undergoing upfront surgical removal of the primary tumor.
- Allergy to specific contrast agents or blood products.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Florida Proton Therapy Institute | 32206 | Jacksonville | Florida |
| Nemours Children's Clinic | 32207 | Jacksonville | Florida |
| St. Jude Children's Research Hospital | 38105 | Memphis | Tennessee |
| Cook Children's Medical Center | 76104 | Fort Worth | Texas |
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