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

Mayo Clinic

Status: Enrolling

Conditions: Pelvic Rhabdomyosarcoma; Ewing Sarcoma of Bone; Chondrosarcoma; Chordoma; Bone Sarcoma

Treatments: Other: Quality-of-Life Assessment; Other: Electronic Health Record Review

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05033288

NCI-2021-08847 (Registry Identifier)

ROF2181

21-004080 (Other Identifier)

MC210709 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

72 participants in 1 patient group

Observational (questionnaires, medical record review)

Description:

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.

Treatment:

Other: Electronic Health Record Review

Other: Quality-of-Life Assessment