학술논문
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.
Document Type
Academic Journal
Author
Hoppe BS; Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL 32224, USA.; Petersen IA; Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA.; Wilke BK; Department of Orthopedic Surgery, Mayo Clinic, Jacksonville, FL 32224, USA.; DeWees TA; Division of Clinical Trials and Biostatistics, Mayo Clinic, Phoenix, AZ 85054, USA.; Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ 85054, USA.; Imai R; Division of Radiation Oncology, QST Hospital, National Institutes for Quantum and Radiological Science and Technology, Chiba 263-8555, Japan.; Hug EB; Department of Radiation Oncology, MedAustron Ion Therapy Center, 2700 Wiener Neustadt, Austria.; Fiore MR; Radiation Oncology Clinical Department, National Center for Oncological Hadrontherapy (CNAO), 27100 Pavia, Italy.; Debus J; Department of Radiation Oncology, University Hospital Heidelberg, 69120 Heidelberg, Germany.; Clinical Cooperation Unit Radiation, German Cancer Research Center, 69120 Heidelberg, Germany.; Fossati P; Department of Radiation Oncology, MedAustron Ion Therapy Center, 2700 Wiener Neustadt, Austria.; Department for Basic and Translational Oncology and Hematology, Karl Landsteiner University of Health Sciences, 3500 Krems, Austria.; Yamada S; Division of Radiation Oncology, QST Hospital, National Institutes for Quantum and Radiological Science and Technology, Chiba 263-8555, Japan.; Orlandi E; Radiation Oncology Clinical Department, National Center for Oncological Hadrontherapy (CNAO), 27100 Pavia, Italy.; Zhang Q; Department of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai 201102, China.; Bao C; Department of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai 201102, China.; Seidensaal K; Department of Radiation Oncology, University Hospital Heidelberg, 69120 Heidelberg, Germany.; Clinical Cooperation Unit Radiation, German Cancer Research Center, 69120 Heidelberg, Germany.; May BC; Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL 32224, USA.; Harrell AC; Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL 32224, USA.; Houdek MT; Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN 55905, USA.; Vallow LA; Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL 32224, USA.; Rose PS; Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN 55905, USA.; Haddock MG; Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA.; Ashman JB; Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ 85054, USA.; Goulding KA; Department of Orthopedic Surgery, Mayo Clinic, Phoenix, AZ 85054, USA.; Attia S; Division of Hematology and Medical Oncology, Mayo Clinic, Jacksonville, FL 32224, USA.; Krishnan S; Department of Radiation Oncology, University of Texas Health Houston Neurosciences-Texas Medical Center, Houston, TX 77030, USA.; Mahajan A; Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA.; Foote RL; Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA.; Laack NN; Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA.; Keole SR; Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ 85054, USA.; Beltran CJ; Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL 32224, USA.; Welch EM; Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA.; Karim M; Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN 55905, USA.; Ahmed SK; Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ 85054, USA.
Source
Publisher: MDPI Country of Publication: Switzerland NLM ID: 101526829 Publication Model: Electronic Cited Medium: Print ISSN: 2072-6694 (Print) Linking ISSN: 20726694 NLM ISO Abbreviation: Cancers (Basel) Subsets: PubMed not MEDLINE
Subject
Language
English
ISSN
2072-6694
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.