Bone SarcomaNCT05033288
Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone
An observational study of Bone Sarcoma and Chondrosarcoma, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Bone Sarcoma, Chondrosarcoma, Chordoma
- What is being tested?
- Electronic Health Record Review and Quality-of-Life Assessment
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jan 2022to 30 Aug 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
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- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Bradford S. Hoppe, MD
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Meng Welliver, MD, PhD
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Jonathan B. Ashman, MD, PhD
About this study
Official title: Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue/Bone) Involving the Bone
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Electronic Health Record Review, Quality-of-Life Assessment
- Medical subject headings
- Bone Neoplasms, Chondrosarcoma, Chordoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Medical records are reviewed
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete quality of life questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electronic Health Record Review; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 years after completion of treatment
Secondary outcomes (3)
Secondary and exploratory analyses on toxicity data
Secondary and exploratory analyses on data will be conducted utilizing standard logistic regression analysis for acute (< 6 months) and late (> 6 months) toxicity.
Measured: Up to 5 years after completion of treatment
Secondary and exploratory analyses on dose volume histogram (DVH) data
Secondary and exploratory analyses on data will be conducted utilizing standard logistic regression analysis for acute (< 6 months) and late (> 6 months) toxicity.
Measured: Up to 5 years after completion of treatment
Dose volume histogram
Secondary and exploratory analyses on toxicity and DVH data will be conducted utilizing standard logistic regression analysis for acute (< 6 months) and late (> 6 months) toxicity. Receiver-operator curves and area-under-the curve will be computed separately for each DVH metric to determine the effect on toxicity, QOL, local control and survival.
Measured: Up to 5 years after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start20 Jan 2022
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone SarcomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradford S. Hoppe, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033288
- Sponsor's protocol ID
- MC210709
- Other IDs
- NCI-2021-08847, MC210709, 21-004080, ROF2181
- Status last verified
- Mar 2026
- First submitted
- 23 Aug 2021
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes