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

Chondrosarcoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033288
• Other study ID #: ROF2181
• Secondary ID: NCI-2021-08847MC
• Status: Recruiting
• Start date: January 20, 2022
• Est. completion date: August 30, 2028

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 30, 2028
• Est. primary completion date: August 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Sarcoma
• Chondrosarcoma
• Chordoma
• Ewing Sarcoma of Bone
• Rhabdomyosarcoma
• Sarcoma
• Sarcoma, Ewing

Intervention

Other:
• Electronic Health Record Review
Medical records are reviewed
• Quality-of-Life Assessment
Complete quality of life questionnaires

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Up to 5 years after completion of treatment
Secondary	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.	Up to 5 years after completion of treatment
Secondary	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.	Up to 5 years after completion of treatment

External Links

•   Mayo Clinic Clinical Trials