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

NCT05033288 | Recruiting DMC FDA Device

• 4 other identifiers: MC210709NCI-2021-0884721-004080ROF2181
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Average difference in change of functional quality of life (QOL)

  Will be compared between patients who received carbon ion radiation therapy (CIRT) and surgery utilizing a one-sided test for a two sample t-test for independent means. The Patient Reported Outcomes Measurement Information System (PROMIS)-29 functional score will be calculated and median, mean, and 95% confidence interval will be computed for each arm, with one-sided two-sample t-tests conducted between the surgery +/- radiation therapy (RT) and CIRT arm.

  Baseline (pre-treatment) to 1 year after completion of treatment

• Proportion of patients experiencing local control

  Will be calculated along with 95% confidence intervals with a one-sided test for non-inferiority to be conducted between the PT and CIRT arms.

  Up to 5 years after completion of treatment

• Progression-free survival - local control

  The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including local control as well as progression-free survival for each arm and stratified by arm.

  Up to 5 years after completion of treatment

• Progression-free survival - regional control

  The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including regional control as well as progression-free survival for each arm and stratified by arm.

  Up to 5 years after completion of treatment

• Progression-free survival - distant control

  The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including distant control as well as progression-free survival for each arm and stratified by arm.

  Up to 5 years after completion of treatment

• Overall survival - local control

  The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including local control as well as overall survival for each arm and stratified by arm.

  Up to 5 years after completion of treatment

• Overall survival - regional control

  The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including regional control as well as overall survival for each arm and stratified by arm.

  Up to 5 years after completion of treatment

• Overall survival - distant control

  The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including distant control as well as overall survival for each arm and stratified by arm.

  Up to 5 years after completion of treatment

Secondary Outcomes (3)

• Secondary and exploratory analyses on toxicity data

  Up to 5 years after completion of treatment

• Secondary and exploratory analyses on dose volume histogram (DVH) data

  Up to 5 years after completion of treatment

• Dose volume histogram

  Up to 5 years after completion of treatment

Study Arms (1)

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.

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

Interventions

Electronic Health Record Review OTHER

Medical records are reviewed

Observational (questionnaires, medical record review)

Quality-of-Life Assessment OTHER

Complete quality of life questionnaires

Also known as: Quality of Life Assessment

Observational (questionnaires, medical record review)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with 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 treated with curative intent carbon ion radiation therapy (CIRT) at one of the carbon ion facilities in Europe or Asia or deemed appropriate to undergo definitive treatment with surgery or radiation therapy at Mayo Clinic (Minnesota, Florida, Arizona)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Bone Neoplasms; Chondrosarcoma; Chordoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Germ Cell and Embryonal

Study Officials

• Bradford S. Hoppe, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 2, 2021
• Study Start: January 20, 2022
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2031
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (3)