UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053705 |
|---|---|
| Receipt number | R000061276 |
| Scientific 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 |
| Date of disclosure of the study information | 2024/02/26 |
| Last modified on | 2024/02/26 11:00:15 |
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Basic information
Public 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
Acronym
PROSPER Trial
Scientific 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
Scientific Title:Acronym
PPROSPER Trial
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
pelvic bone or soft tissue sarcomas involving pelvic bone
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to demonstrate whether carbon ion therapy provides improved patient reported health related quality of life (PRO-HRQOL) outcomes and less significant toxicities
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To demonstrate whether carbon ion therapy provides improved patient reported health related quality of life (PRO-HRQOL) outcomes and less significant toxicities.
Key secondary outcomes
To demonstrate whether carbon ion therapy provides improved local control versus proton therapy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Bradford |
| Middle name | |
| Last name | Hoppe |
Organization
Mayo Clinic
Division name
Radiation Oncology
Zip code
32224
Address
4500 San Pablo Rd Jacksonville, FL
TEL
904-953-1000
Hoppe.Bradford@mayo.edu
Public contact
Name of contact person
| 1st name | Bradford |
| Middle name | |
| Last name | Hoppe |
Organization
Mayo Clinic
Division name
Radiation Oncology
Zip code
32224
Address
4500 San Pablo Rd Jacksonville, FL
TEL
904-953-1000
Homepage URL
Hoppe.Bradford@mayo.edu
Sponsor or person
Institute
Mayo Clinic
Institute
Department
Personal name
Funding Source
Organization
Mayo Clinic
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mayo Clinic
Address
4500 San Pablo Rd Jacksonville, FL
Tel
904-953-1000
Hoppe.Bradford@mayo.edu
Secondary IDs
Secondary IDs
YES
Study ID_1
MC210709
Org. issuing International ID_1
Mayo Clinic
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Arm 1 CIRT cohort Arm 2 surgical cohort and Arm 3 PT cohort.
Management information
Registered date
| 2024 | Year | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061276
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| Registered date | File name |
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| Registered date | File name |
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