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

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ClinicalTrials.gov Identifier: NCT05033288
Recruitment Status : Recruiting
First Posted : September 2, 2021
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment
Bone Sarcoma Chondrosarcoma Chordoma Ewing Sarcoma of Bone Pelvic Rhabdomyosarcoma Other: Electronic Health Record Review Other: Quality-of-Life Assessment

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 Design
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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 20, 2022
Estimated Primary Completion Date : August 30, 2027
Estimated Study Completion Date : August 30, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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: Electronic Health Record Review
Medical records are reviewed

Other: Quality-of-Life Assessment
Complete quality of life questionnaires
Other Name: Quality of Life Assessment


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05033288


Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Jonathan B. Ashman, M.D.         
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224-9980
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Bradford S. Hoppe, M.D.         
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Ivy A. Petersen, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Bradford S Hoppe Mayo Clinic
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT05033288    
Other Study ID Numbers: ROF2181
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 )
ROF2181 ( Other Identifier: Mayo Clinic Radiation Oncology )
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Sarcoma
Rhabdomyosarcoma
Sarcoma, Ewing
Chondrosarcoma
Chordoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal