Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer
NCT ID: NCT02739659
Last Updated: 2021-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
73 participants
INTERVENTIONAL
2016-01-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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carbon-ion radiotherapy
Five dose levels \[59.2 GyE(Gray equivalent)/16Fx, 60.8 GyE/16Fx, 62.4 GyE/16Fx, 64.0 GyE/16Fx and 65.6 GyE/16Fx\] are planned within the Phase I part. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 65.6 GyE/16Fx are safely delivered, the recommended dose (or 65.6 GyE/16Fx) will be the prescribed dose in the Phase II part of the study.
carbon-ion radiotherapy
Interventions
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carbon-ion radiotherapy
Eligibility Criteria
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Inclusion Criteria
* No lymph node and distant metastasis
* Age ≥ 20 and \< 85 years of age
* Karnofsky Performance Score ≥70
* No previous pelvic radiation therapy (RT)
* No previous prostatectomy
* No previous invasive cancer (within 5 years before the prostate cancer diagnosis)except for skin non-melanoma cancer
* Ability to understand character and individual consequences of the clinical trial
* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial
Exclusion Criteria
* Pelvic lymph node metastasis (N1)
* Distant metastasis (M1)
* Urinary obstructive symptoms (IPSS \> 20)
* Previous pelvic radiotherapy
* Previous prostatectomy
* Severe systemic disorders
* Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
* Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer
* Non conformity of the radiotherapy dose distribution when compared to the dose constraints
* Psychiatric disorders or any other condition that can make unreliable the informed consent
20 Years
85 Years
MALE
No
Sponsors
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Shanghai Proton and Heavy Ion Center
OTHER
Responsible Party
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Qing Zhang,MD
DIRECTOR
Principal Investigators
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Qing Zhang, Dr.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Proton and Heavy Ion Center
Locations
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Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Ping Li, Dr.
Role: primary
Qing Zhang, Dr.
Role: backup
References
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Zhang Y, Li P, Yu Q, Wu S, Chen X, Zhang Q, Fu S. Preliminary exploration of clinical factors affecting acute toxicity and quality of life after carbon ion therapy for prostate cancer. Radiat Oncol. 2019 Jun 4;14(1):94. doi: 10.1186/s13014-019-1303-3.
Other Identifiers
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SPHIC-TR-PCa 2015-01
Identifier Type: -
Identifier Source: org_study_id