Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer

Last updated: February 5, 2020
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Cancer

Digestive System Neoplasms

Cancer

Treatment

N/A

Clinical Study ID

NCT03882866
2018clinicethicreview215
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 18-80 years

  • Cytologically or histologically confirmed pancreatic adenocarcinoma

  • Inoperable locally advanced pancreatic cancer based on American Joint Committee onCancer (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 × institutionalupper 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

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/IVcongestive heart failure,active coronary heart disease and severe arrhythmia

  • Uncontrolled hypertension

  • Ongoing or active infection (>grade 2 based on National Cancer Institute-CommonTerminology 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

Study Design

Total Participants: 220
Study Start date:
March 28, 2019
Estimated Completion Date:
September 30, 2021

Study 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.

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui
    China

    Active - Recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Hebei General Hospital

    Shijiazhuang, Hebei
    China

    Active - Recruiting

  • Zhongda Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • The Second Hospital of Shandong University

    Jinan, Shandong
    China

    Active - Recruiting

  • Teng Zhou Central People's Hospital

    Zaozhuang, Shandong
    China

    Active - Recruiting

  • Huadong Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

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