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

Recruiting

• Conditions: Chondrosarcoma; Chordoma; Bone Sarcoma; Pelvic Rhabdomyosarcoma; Ewing Sarcoma of Bone
• Interventions: Other: Electronic Health Record Review; Other: Quality-of-Life Assessment

• Registration Number: NCT05033288
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-02
• Study Start: 2022-01-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2027-08-30
• Study Completion: 2028-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaires, medical record review)	Quality-of-Life Assessment	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.
Observational (questionnaires, medical record review)	Electronic Health 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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival - regional control	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.
Progression-free survival - local control	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.
Progression-free survival - distant control	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.
Overall survival - local control	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.
Overall survival - regional control	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.
Overall survival - distant control	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.
Average difference in change of functional quality of life (QOL)	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.
Proportion of patients experiencing local control	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.

Secondary Outcome Measures

Name	Time	Method
Secondary and exploratory analyses on toxicity data	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.
Secondary and exploratory analyses on dose volume histogram (DVH) data	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.
Dose volume histogram	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.

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States