Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Dosimetric verification was performed after implantation. Pre- and postoperative D90, V100, and V150 were calculated. The success rate of iodine-125 seed implantation, dosimetric parameters, objective response rate (ORR)，overall survival (OS)，toxicities and quality of life of two treatment regimens and complications were analyzed and compared between the two groups.

Official Title
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3D-printed Template for Iodine-125 Seed Implantation Therapy in Patients With Locally Advanced Pancreatic Cancer: a Multicenter Study

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: 3D-printed non-coplanar template
* Procedure: 3D-printed coplanar template


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-printed non-coplanar template<br>3D-printed non-coplanar template is used in this group. | Procedure: 3D-printed non-coplanar template<br>* 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.<br>|
| Active Comparator: 3D-printed coplanar template<br>3D-printed coplanar template is used in this group. | Procedure: 3D-printed coplanar template<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause, or censored at date last known alive. | 24 months | 
| Incidence of treatment-emergent toxicities of two treatment regimens in patients | The toxicity criteria of the Radiation Therapy Oncology Group (RTOG) were applied to assess the acute and late adverse effects of irradiation. | 24 months | 
| Quality of life of two treatment regimens in patients | Quality of life will be evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)C30 Questionnaire. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iodine-125, Three-Dimensional Printing, Brachytherapy, template