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Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer | Clinical Trials | Clareo Health

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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

NCT03882866•Ruijin Hospital

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

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
+2 more criteria

Locations (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

Key Dates

Start Date

March 28, 2019

Primary Completion Date

June 30, 2021

Completion Date

September 30, 2021

Last Updated

February 6, 2020

Enrollment

220

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

3D-printed non-coplanar template

PROCEDURE

3D-printed coplanar template

PROCEDURE

Contacts

Zhongmin Wang, MD

CONTACT

0086-13901848333 wzm0722@hotmail.com

Qungang Shan, MD

CONTACT

0086-15989037568 qungangshan@sjtu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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