Clinical trial NCT05033288: Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Sarcoma
Chondrosarcoma
Chordoma
Ewing Sarcoma of Bone
Pelvic Rhabdomyosarcoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 72
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility 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

Primary outcomes:
measure: Average difference in change of functional quality of life (QOL)
timeFrame: Baseline (pre-treatment) to 1 year after completion of treatment
measure: Proportion of patients experiencing local control
timeFrame: Up to 5 years after completion of treatment
measure: Progression-free survival - local control
timeFrame: Up to 5 years after completion of treatment
measure: Progression-free survival - regional control
timeFrame: Up to 5 years after completion of treatment
measure: Progression-free survival - distant control
timeFrame: Up to 5 years after completion of treatment
measure: Overall survival - local control
timeFrame: Up to 5 years after completion of treatment
measure: Overall survival - regional control
timeFrame: Up to 5 years after completion of treatment
measure: Overall survival - distant control
timeFrame: Up to 5 years after completion of treatment
Secondary outcomes:
measure: Secondary and exploratory analyses on toxicity data
timeFrame: Up to 5 years after completion of treatment
measure: Secondary and exploratory analyses on dose volume histogram (DVH) data
timeFrame: Up to 5 years after completion of treatment
measure: Dose volume histogram
timeFrame: Up to 5 years after completion of treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bradford S. Hoppe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: