Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05033288
Status
Recruiting
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Conditions

  • Bone Sarcoma
  • Chondrosarcoma
  • Chordoma
  • Ewing Sarcoma of Bone
  • Pelvic Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Electronic Health Record Review — OTHER
    Medical records are reviewed
  • Quality-of-Life Assessment — OTHER
    Complete quality of life questionnaires

Study Details

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.

Key Dates

Start date
Jan 20, 2022
Status verified
Mar 2026
Primary completion
Aug 30, 2027
Completion
Aug 30, 2031

Study Design

Enrollment
72 participants (estimated)

Arms

  • Arm: Observational (questionnaires, medical record review)
    Patients complete quality of life questionnaires over 20 minutes at baseline (before any therapy), 2-4 and 5-9 months after completion of therapy, and then annually for up to 5 years. Patients' medical records are also reviewed.

Primary Outcome Measure

Average difference in change of functional quality of life (QOL) [ Time Frame: Baseline (pre-treatment) to 1 year after completion of treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Jonathan B. Ashman, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Bradford S. Hoppe, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Meng Welliver, MD, PhD (PRINCIPAL_INVESTIGATOR)

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