Cancers (Mar 2023)
Pragmatic, Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue/Bone) Involving the Bone: The PROSPER Study Rationale and Design
- Bradford S. Hoppe,
- Ivy A. Petersen,
- Benjamin K. Wilke,
- Todd A. DeWees,
- Reiko Imai,
- Eugen B. Hug,
- Maria Rosaria Fiore,
- Jürgen Debus,
- Piero Fossati,
- Shigeru Yamada,
- Ester Orlandi,
- Qing Zhang,
- Cihang Bao,
- Katharina Seidensaal,
- Byron C. May,
- Anna C. Harrell,
- Matthew T. Houdek,
- Laura A. Vallow,
- Peter S. Rose,
- Michael G. Haddock,
- Jonathan B. Ashman,
- Krista A. Goulding,
- Steven Attia,
- Sunil Krishnan,
- Anita Mahajan,
- Robert L. Foote,
- Nadia N. Laack,
- Sameer R. Keole,
- Chris J. Beltran,
- Eric M. Welch,
- Mohammed Karim,
- Safia K. Ahmed
Affiliations
- Bradford S. Hoppe
- Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL 32224, USA
- Ivy A. Petersen
- Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA
- Benjamin K. Wilke
- Department of Orthopedic Surgery, Mayo Clinic, Jacksonville, FL 32224, USA
- Todd A. DeWees
- Division of Clinical Trials and Biostatistics, Mayo Clinic, Phoenix, AZ 85054, USA
- Reiko Imai
- Division of Radiation Oncology, QST Hospital, National Institutes for Quantum and Radiological Science and Technology, Chiba 263-8555, Japan
- Eugen B. Hug
- Department of Radiation Oncology, MedAustron Ion Therapy Center, 2700 Wiener Neustadt, Austria
- Maria Rosaria Fiore
- Radiation Oncology Clinical Department, National Center for Oncological Hadrontherapy (CNAO), 27100 Pavia, Italy
- Jürgen Debus
- Department of Radiation Oncology, University Hospital Heidelberg, 69120 Heidelberg, Germany
- Piero Fossati
- Department of Radiation Oncology, MedAustron Ion Therapy Center, 2700 Wiener Neustadt, Austria
- Shigeru Yamada
- Division of Radiation Oncology, QST Hospital, National Institutes for Quantum and Radiological Science and Technology, Chiba 263-8555, Japan
- Ester Orlandi
- Radiation Oncology Clinical Department, National Center for Oncological Hadrontherapy (CNAO), 27100 Pavia, Italy
- Qing Zhang
- Department of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai 201102, China
- Cihang Bao
- Department of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai 201102, China
- Katharina Seidensaal
- Department of Radiation Oncology, University Hospital Heidelberg, 69120 Heidelberg, Germany
- Byron C. May
- Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL 32224, USA
- Anna C. Harrell
- Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL 32224, USA
- Matthew T. Houdek
- Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN 55905, USA
- Laura A. Vallow
- Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL 32224, USA
- Peter S. Rose
- Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN 55905, USA
- Michael G. Haddock
- Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA
- Jonathan B. Ashman
- Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ 85054, USA
- Krista A. Goulding
- Department of Orthopedic Surgery, Mayo Clinic, Phoenix, AZ 85054, USA
- Steven Attia
- Division of Hematology and Medical Oncology, Mayo Clinic, Jacksonville, FL 32224, USA
- Sunil Krishnan
- Department of Radiation Oncology, University of Texas Health Houston Neurosciences-Texas Medical Center, Houston, TX 77030, USA
- Anita Mahajan
- Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA
- Robert L. Foote
- Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA
- Nadia N. Laack
- Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA
- Sameer R. Keole
- Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ 85054, USA
- Chris J. Beltran
- Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL 32224, USA
- Eric M. Welch
- Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA
- Mohammed Karim
- Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN 55905, USA
- Safia K. Ahmed
- Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ 85054, USA
- DOI
- https://doi.org/10.3390/cancers15061660
- Journal volume & issue
-
Vol. 15,
no. 6
p. 1660
Abstract
Surgical treatment of pelvic sarcoma involving the bone is the standard of care but is associated with several sequelae and reduced functional quality of life (QOL). Treatment with photon and proton radiotherapy is associated with relapse. Carbon ion radiotherapy (CIRT) may reduce both relapse rates and treatment sequelae. The PROSPER study is a tricontinental, nonrandomized, prospective, three-arm, pragmatic trial evaluating treatments of pelvic sarcoma involving the bone. Patients aged at least 15 years are eligible for inclusion. Participants must have an Eastern Cooperative Oncology Group Performance Status score of two or less, newly diagnosed disease, and histopathologic 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. Treatment arms include (1) CIRT (n = 30) delivered in Europe and Asia, (2) surgical treatment with or without adjuvant radiotherapy (n = 30), and (3) proton therapy (n = 30). Arms two and three will be conducted at Mayo Clinic campuses in Arizona, Florida, and Minnesota. The primary end point is to compare the 1-year change in functional QOL between CIRT and surgical treatment. Additional comparisons among the three arms will be made between treatment sequelae, local control, and other QOL measures.
Keywords