Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer
3D-printed Template for Iodine-125 Seed Implantation Therapy in Patients With Locally Advanced Pancreatic Cancer: a Multicenter Study
1 other identifier
interventional
220
1 country
8
Brief Summary
This study evaluates the application of 3D-printed template for iodine-125 seed implantation therapy in patients with locally advanced pancreatic cancer. Half of participants will receive 3D-printed coplanar template, while the other half will receive 3D-printed non-coplanar template.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pancreatic-cancer
Started Mar 2019
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 20, 2019
CompletedStudy Start
First participant enrolled
March 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedFebruary 6, 2020
February 1, 2020
2.3 years
March 19, 2019
February 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1.
24 months
Secondary Outcomes (3)
Overall Survival (OS)
24 months
Incidence of treatment-emergent toxicities of two treatment regimens in patients
24 months
Quality of life of two treatment regimens in patients
24 months
Study Arms (2)
3D-printed non-coplanar template
EXPERIMENTAL3D-printed non-coplanar template is used in this group.
3D-printed coplanar template
ACTIVE COMPARATOR3D-printed coplanar template is used in this group.
Interventions
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 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
You may qualify if:
- Age: 18-80 years
- 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
You may not qualify if:
- Patients with other malignant tumors
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
- Hebei General Hospitalcollaborator
- Zhongda Hospitalcollaborator
- Anhui Provincial Hospitalcollaborator
- The Second Hospital of Shandong Universitycollaborator
- Sun Yat-sen Universitycollaborator
- Chinese PLA General Hospitalcollaborator
- Huadong Hospitalcollaborator
- Tengzhou Central People's Hospitalcollaborator
Study Sites (8)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhongmin Wang, MD
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 19, 2019
First Posted
March 20, 2019
Study Start
March 28, 2019
Primary Completion
June 30, 2021
Study Completion
September 30, 2021
Last Updated
February 6, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share