| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Carcinoma | Radiation: proton and carbon ion radiotherapy | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 10 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Trial of Proton and Carbon Ion Radiation Dose Escalation in Patients With Locally Advanced Pancreatic Cancer |
| Actual Study Start Date : | May 1, 2015 |
| Actual Primary Completion Date : | October 31, 2016 |
| Actual Study Completion Date : | October 31, 2016 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: proton and carbon ion radiotherapy
proton and carbon ion radiotherapy
|
Radiation: proton and carbon ion radiotherapy
proton and carbon ion radiotherapy
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| China, Shanghai | |
| Shanghai Proton and Heavy Ion Center | |
| Shanghai, Shanghai, China, 201315 | |
| Principal Investigator: | guoliang Jiang, Dr. | Shanghai Proton and Heavy Ion Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 7, 2019 | ||||
| First Posted Date ICMJE | May 14, 2019 | ||||
| Last Update Posted Date | March 5, 2020 | ||||
| Actual Study Start Date ICMJE | May 1, 2015 | ||||
| Actual Primary Completion Date | October 31, 2016 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Time interval from the start of radiotherapy to 3 months after the completion of radiotherapy ] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer | ||||
| Official Title ICMJE | A Phase I Trial of Proton and Carbon Ion Radiation Dose Escalation in Patients With Locally Advanced Pancreatic Cancer | ||||
| Brief Summary | The aim of this study is to evaluate the toxicity and tolerance of proton and carbon ion radiotherapy (PCRT) for locally advanced pancreatic carcinoma (LAPC) | ||||
| Detailed Description | The proton dose of 50.4GyE in 28 fractions was delivered to clinical target volume (CTV), and carbon ion as a boost dose to gross tumor volume (GTV) escalated from 12GyE to 18GyE with 3GyE per fraction in 3 dose levels. The dose limiting toxicity (DLT) was defined as CTCAE grade 3 or higher of non-hematological toxicity (G3). The acute and late toxicities, overall survival (OS), progression-free survival (PFS), local progression-free survival (LPFS) and distant metastasis-free survival (DMFS) were the endpoints. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Pancreatic Carcinoma | ||||
| Intervention ICMJE | Radiation: proton and carbon ion radiotherapy
proton and carbon ion radiotherapy
|
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| Study Arms ICMJE | Experimental: proton and carbon ion radiotherapy
proton and carbon ion radiotherapy
Intervention: Radiation: proton and carbon ion radiotherapy
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
10 | ||||
| Original Estimated Enrollment ICMJE |
9 | ||||
| Actual Study Completion Date ICMJE | October 31, 2016 | ||||
| Actual Primary Completion Date | October 31, 2016 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03949933 | ||||
| Other Study ID Numbers ICMJE | SPHIC-TR-PaCa2015-10 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Guoliang Jiang, Shanghai Proton and Heavy Ion Center | ||||
| Study Sponsor ICMJE | Shanghai Proton and Heavy Ion Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Shanghai Proton and Heavy Ion Center | ||||
| Verification Date | March 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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