Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer
NCT ID: NCT03882866
Last Updated: 2020-02-06
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
220 participants
INTERVENTIONAL
2019-03-28
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3D-printed non-coplanar template
3D-printed non-coplanar template is used in this group.
3D-printed non-coplanar template
3D-printed non-coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed non-coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed non-coplanar template is designed and printed according to a preoperative CT scan and treatment planning system.
3D-printed coplanar template
3D-printed coplanar template is used in this group.
3D-printed coplanar template
3D-printed coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed coplanar template is designed and printed according to a preoperative CT scan and treatment planning system.
Interventions
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3D-printed non-coplanar template
3D-printed non-coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed non-coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed non-coplanar template is designed and printed according to a preoperative CT scan and treatment planning system.
3D-printed coplanar template
3D-printed coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed coplanar template is designed and printed according to a preoperative CT scan and treatment planning system.
Eligibility Criteria
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Inclusion Criteria
* Cytologically or histologically confirmed pancreatic adenocarcinoma
* Inoperable locally advanced pancreatic cancer based on American Joint Committee on Cancer (AJCC) staging system (8th ed) (without distant metastasis)
* Single tumor size≤ 6 cm
* Karnofsky performance score （KPS）≥60
* Estimated survival ≥3 months
* Without other several comorbidity
* Participants must have adequate organ function:
* WBC≥3×109/L; HGB≥90g/dL; PLT≥50×109/L
* Aspartate Transaminase (AST)/alanine aminotransferase ( ALT) ≤3 × institutional upper limit of normal
* Albumin≥3g/dL
* Total bilirubin ≤3mg/dL
* PT≤3 × institutional upper limit of normal or INR≤2.3
* Creatinine ≤1.5 × institutional upper limit of normal
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* History of other anti-cancer therapy, including surgery,radiation, ablation and so on
* Pregnant or lactating women
* Patients with Immunodeficiency disease
* Several heart disease, for example: New York Heart Association (NYHA) class III/IV congestive heart failure，active coronary heart disease and severe arrhythmia
* Uncontrolled hypertension
* Ongoing or active infection (\>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)
* Active tuberculosis
* Chronic renal insufficiency
* Other organ failure
* History of organ transplantation
* History of severe mental illness
18 Years
80 Years
ALL
No
Sponsors
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Hebei General Hospital
OTHER
Zhongda Hospital
OTHER
Anhui Provincial Hospital
OTHER_GOV
The Second Hospital of Shandong University
OTHER
Sun Yat-sen University
OTHER
Chinese PLA General Hospital
OTHER
Huadong Hospital
OTHER
Tengzhou Central People's Hospital
OTHER_GOV
Ruijin Hospital
OTHER
Responsible Party
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Zhongmin Wang
Principal Investigator
Principal Investigators
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Zhongmin Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Hebei General Hospital
Shijiazhuang, Hebei, China
Zhongda Hospital
Nanjing, Jiangsu, China
The Second Hospital of Shandong University
Jinan, Shandong, China
Teng Zhou Central People's Hospital
Zaozhuang, Shandong, China
Huadong Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Weifu Lv
Role: primary
Yueyong Xiao, MD
Role: primary
Fujun Zhang, MD
Role: primary
Juan Wang, MD
Role: primary
Jinhe Guo, MD
Role: primary
Yuliang Li, MD
Role: primary
Kaixian Zhang, MD
Role: primary
Hong Zhao
Role: primary
Other Identifiers
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2018clinicethicreview215
Identifier Type: -
Identifier Source: org_study_id
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