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

Last updated: March 31, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoma

Rhabdomyosarcoma

Soft Tissue Sarcoma

Treatment

Electronic Health Record Review

Quality-of-Life Assessment

Clinical Study ID

NCT05033288
MC210709
NCI-2021-08847
21-004080
MC210709
ROF2181
  • Ages > 15
  • All Genders

Study 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

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 boneinvolvement or non-RMS soft tissue sarcoma with bone involvement

  • No evidence of distant sarcoma metastases as determined by clinical examination andany 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

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 suchthat it would be partially or completely encompassed by the radiation volume neededto treat the current sarcoma. In other words, treatment on this study would requirere-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 adequatecontraception

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Electronic Health Record Review
Phase:
Study Start date:
January 20, 2022
Estimated Completion Date:
August 30, 2028

Study Description

PRIMARY OBJECTIVES:

I. Demonstrate whether carbon ion therapy provides improved patient reported health related quality of life (PRO-HRQOL) outcomes and less significant toxicities compared with surgery.

II. Demonstrate whether carbon ion therapy provides improved local control versus proton therapy.

OUTLINE:

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.

Connect with a study center

  • Mayo Clinic in Arizona

    Scottsdale, Arizona 85259
    United States

    Active - Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224-9980
    United States

    Active - Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.