Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Electronic Health Record Review
Other interventionMedical records are reviewed
Quality-of-Life Assessment
Other interventionComplete quality of life questionnaires
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: Observational (questionnaires, medical record review)2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (pre-treatment) to 1 year after completion of treatment2
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.
Time frame
Up to 5 years after completion of treatment3
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.
Time frame
Up to 5 years after completion of treatment4
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.
Time frame
Up to 5 years after completion of treatmentSecondary outcomes
1
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.
Time frame
Up to 5 years after completion of treatment2
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.
Time frame
Up to 5 years after completion of treatment3
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.
Time frame
Up to 5 years after completion of treatmentSponsors and contacts
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Source ClinicalTrials.gov