RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-01-20
Study Completion:2028-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05033288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females \>= 15 years of age
  2. * 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
  3. * No evidence of distant sarcoma metastases as determined by clinical examination and any form of imaging
  4. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
  5. * Patients capable of childbearing must agree to use adequate contraception
  6. * Ability to complete questionnaire(s) by themselves or with assistance
  7. * Ability to provide written informed consent
  8. * Chemotherapy per institutional guidelines is allowed
  1. * Patients receiving palliative treatment
  2. * Recurrent disease
  3. * Males and females \< 15 years of age
  4. * 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
  5. * Patients with distant sarcoma metastases
  6. * Benign pelvic bone histologies
  7. * Any of the following:
  8. * Pregnant women
  9. * Nursing women
  10. * Men or women of childbearing potential who are unwilling to employ adequate contraception

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Bradford S. Hoppe, MD, MPH
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Bradford S. Hoppe, MD, MPH, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-20
Study Completion Date2028-08-30

Study Record Updates

Study Start Date2022-01-20
Study Completion Date2028-08-30

Terms related to this study

Additional Relevant MeSH Terms

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