Prospective comparative effectiveness trial of carbon ion therapy, surgery, and proton therapy for the management of pelvic sarcomas (soft tissue/bone) involving the bone

Prospective comparative effectiveness trial of carbon ion therapy, surgery, and proton therapy for the management of pelvic sarcomas (soft tissue/bone) involving the bone - PPROSPER Trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053705

Enrollment

Registered

2024-02-26

Start date

2024-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pelvic bone or soft tissue sarcomas involving pelvic bone

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female patients, aged greater than or equal to 15 years Newly diagnosed, histologic confirmation of pelvic chordoma, chondrosarcoma, osteosarcoma, or nonrhabdomyosarcoma (RMS) and soft tissue sarcoma with bone involvement Patients with Ewing sarcoma and RMS are eligible if the tumors involve bone and are staged as T2b, T3b, T4a, or T4b per the American Joint Cancer Committee (AJCC) 8th Edition Bone Sarcoma staging (Appendix II) No evidence of distant sarcoma metastases as determined by clinical examination and any form of imaging. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) less than or equal to 2 Patients capable of childbearing must agree to use adequate contraception. Ability to complete questionnaire(s) by themselves or with assistance. Ability to sign the informed consent, by patient or a legally acceptable representative before any study related activities are undertaken. Chemotherapy per institutional guidelines is allowed.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To demonstrate whether carbon ion therapy provides improved patient reported health related quality of life (PRO-HRQOL) outcomes and less significant toxicities.	—

Secondary

Measure	Time frame
To demonstrate whether carbon ion therapy provides improved local control versus proton therapy.	—

Countries

Japan,Asia(except Japan),North America,Europe

Contacts

Public ContactBradford Hoppe

Mayo Clinic Radiation Oncology

Hoppe.Bradford@mayo.edu904-953-1000

Outcome results