Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer

February 5, 2020 updated by: Zhongmin Wang, Ruijin Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
          • Weifu Lv
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
          • Yueyong Xiao, MD
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Fujun Zhang, MD
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Hebei General Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Zhongda Hospital
        • Contact:
          • Jinhe Guo, MD
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • The Second Hospital of Shandong University
        • Contact:
          • Yuliang Li, MD
      • Zaozhuang, Shandong, China
        • Recruiting
        • Teng Zhou Central People's Hospital
        • Contact:
          • Kaixian Zhang, MD
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Huadong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 3D-printed non-coplanar template
3D-printed non-coplanar template is used in this group.
Procedure: 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.
ACTIVE_COMPARATOR: 3D-printed coplanar template
3D-printed coplanar template is used in this group.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 24 months
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)
Time Frame: 24 months
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
Time Frame: 24 months
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
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Sun Yat-sen University
Chinese PLA General Hospital
Hebei General Hospital
Zhongda Hospital
The Second Hospital of Shandong University
Anhui Provincial Hospital
Tengzhou Central People's Hospital
Huadong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2019

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

September 30, 2021

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (ACTUAL)

March 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018clinicethicreview215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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