Menu
Recruiting NCT05033288

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

— Observational Bone Sarcoma Chondrosarcoma Chordoma Ewing Sarcoma of Bone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electronic Health Record Review, Quality-of-Life Assessment.
Who it may be relevant to
Registry conditions: Bone Sarcoma, Chondrosarcoma, Chordoma, Ewing Sarcoma of Bone. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Average difference in change of functional quality of life (QOL) [Time frame: Baseline (pre-treatment) to 1 year after completion of treatment]
  • Proportion of patients experiencing local control [Time frame: Up to 5 years after completion of treatment]
  • Progression-free survival - local control [Time frame: Up to 5 years after completion of treatment]
  • Progression-free survival - regional control [Time frame: Up to 5 years after completion of treatment]
  • Progression-free survival - distant control [Time frame: Up to 5 years after completion of treatment]
  • Overall survival - local control [Time frame: Up to 5 years after completion of treatment]
  • Overall survival - regional control [Time frame: Up to 5 years after completion of treatment]
  • Overall survival - distant control [Time frame: Up to 5 years after completion of treatment]
Secondary outcome measures (3)
  • Secondary and exploratory analyses on toxicity data [Time frame: Up to 5 years after completion of treatment]
  • Secondary and exploratory analyses on dose volume histogram (DVH) data [Time frame: Up to 5 years after completion of treatment]
  • Dose volume histogram [Time frame: Up to 5 years after completion of treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 3 centers
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Florida — Jacksonville
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT05033288 · MC210709 · NCI-2021-08847 · MC210709 · 21-004080 · ROF2181

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗