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

September 18, 2023 updated by: Mayo Clinic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic in Arizona
        • Principal Investigator:
          • Jonathan B. Ashman, M.D.
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Principal Investigator:
          • Bradford S. Hoppe, M.D.
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Ivy A. Petersen, M.D.
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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: Quality-of-Life Assessment
Complete quality of life questionnaires
Other Names:
  • Quality of Life Assessment
Other: Electronic Health Record Review
Medical records are reviewed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average difference in change of functional quality of life (QOL)
Time Frame: Baseline (pre-treatment) to 1 year after completion of treatment
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
Time Frame: Up to 5 years after completion of treatment
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
Time Frame: Up to 5 years after completion of treatment
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
Time Frame: Up to 5 years after completion of treatment
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
Time Frame: Up to 5 years after completion of treatment
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
Time Frame: Up to 5 years after completion of treatment
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
Time Frame: Up to 5 years after completion of treatment
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
Time Frame: Up to 5 years after completion of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary and exploratory analyses on toxicity data
Time Frame: Up to 5 years after completion of treatment
Secondary and exploratory analyses on data will be conducted utilizing standard logistic regression analysis for acute (< 6 months) and late (> 6 months) toxicity.
Up to 5 years after completion of treatment
Secondary and exploratory analyses on dose volume histogram (DVH) data
Time Frame: Up to 5 years after completion of treatment
Secondary and exploratory analyses on data will be conducted utilizing standard logistic regression analysis for acute (< 6 months) and late (> 6 months) toxicity.
Up to 5 years after completion of treatment
Dose volume histogram
Time Frame: Up to 5 years after completion of treatment
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.
Up to 5 years after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Bradford S Hoppe, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2028

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROF2181 (Other Identifier: Mayo Clinic Radiation Oncology)
  • NCI-2021-08847 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • MC210709 (Other Identifier: Mayo Clinic in Florida)
  • 21-004080 (Other Identifier: Mayo Clinic in Florida)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ewing Sarcoma of Bone

Clinical Trials on Quality-of-Life Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe