NCT05033288 Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone
| NCT ID | NCT05033288 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Bone Sarcoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 72 participants |
| Start Date | 2022-01-20 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 72 participants in total. It began in 2022-01-20 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study compares carbon ion therapy, surgery, and proton therapy to determine if one has better disease control and fewer side effects. There are three types of radiation treatment used for pelvic bone sarcomas: surgery with or without photon/proton therapy, proton therapy alone, and carbon ion therapy alone. The purpose of this study is to compare quality of life among patients treated for pelvic bone sarcomas across the world, and to determine if carbon ion therapy improves quality of life compared to surgery and disease control compared with proton therapy.
Eligibility Criteria
Inclusion Criteria: * Males and females \>= 15 years of age * Newly diagnosed, histologic confirmation of pelvic chordoma, chondrosarcoma, osteosarcoma, Ewing sarcoma with bone involvement, rhabdomyosarcoma (RMS) with bone involvement or non-RMS soft tissue sarcoma with bone involvement * No evidence of distant sarcoma metastases as determined by clinical examination and any form of imaging * Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2 * Patients capable of childbearing must agree to use adequate contraception * Ability to complete questionnaire(s) by themselves or with assistance * Ability to provide written informed consent * Chemotherapy per institutional guidelines is allowed Exclusion Criteria: * Patients receiving palliative treatment * Recurrent disease * Males and females \< 15 years of age * Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be partially or completely encompassed by the radiation volume needed to treat the current sarcoma. In other words, treatment on this study would require re-irradiation of tissues * Patients with distant sarcoma metastases * Benign pelvic bone histologies * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception
Contact & Investigator
Bradford S. Hoppe, MD, MPH
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05033288 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Bone Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05033288 currently recruiting?
Yes, NCT05033288 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT05033288 trial being conducted?
This trial is being conducted at Scottsdale, United States, Jacksonville, United States, Rochester, United States.
Who is sponsoring the NCT05033288 clinical trial?
NCT05033288 is sponsored by Mayo Clinic. The principal investigator is Bradford S. Hoppe, MD, MPH at Mayo Clinic. The trial plans to enroll 72 participants.