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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue/Bone) Involving the Bone

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

Condition
Bone Sarcoma
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic in Arizona, Scottsdale, Arizona, United States, 85259

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224-9980

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

15 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Bradford S. Hoppe, MD, MPH, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2028-08-30