Comparing carbon ion therapy, surgery, and proton therapy for pelvic bone sarcomas
Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue/Bone) Involving the Bone
This study is testing whether carbon ion therapy works better than surgery or proton therapy for treating pelvic bone sarcomas and how these treatments affect patients' quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 72 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Trial ID | NCT05033288 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of carbon ion therapy compared to surgery and proton therapy in managing pelvic bone sarcomas. It aims to determine which treatment offers better disease control and fewer side effects, focusing on patient-reported health-related quality of life outcomes. Patients will complete quality of life questionnaires at various intervals, and their medical records will be reviewed to assess treatment impacts over time. The study includes patients aged 15 and older with newly diagnosed sarcomas involving the bone.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 15 and older with newly diagnosed pelvic bone sarcomas and no evidence of distant metastases.
Not a fit: Patients receiving palliative treatment or those with recurrent disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and quality of life for patients with pelvic bone sarcomas.
How similar studies have performed: While carbon ion therapy is a novel approach, similar studies have shown promising results in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Scottsdale, Arizona and 2 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Bradford S. Hoppe, MD, MPH — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.