search
Back to results

Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3D-printed non-coplanar template
3D-printed coplanar template
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Iodine-125, Three-Dimensional Printing, Brachytherapy, template

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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
    • 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

Sites / Locations

  • Anhui Provincial HospitalRecruiting
  • Chinese PLA General HospitalRecruiting
  • Sun Yat-sen University Cancer CenterRecruiting
  • Hebei General HospitalRecruiting
  • Zhongda HospitalRecruiting
  • The Second Hospital of Shandong UniversityRecruiting
  • Teng Zhou Central People's HospitalRecruiting
  • Huadong HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3D-printed non-coplanar template

3D-printed coplanar template

Arm Description

3D-printed non-coplanar template is used in this group.

3D-printed coplanar template is used in this group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.
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.
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.

Full Information

First Posted
March 19, 2019
Last Updated
February 5, 2020
Sponsor
Ruijin Hospital
Collaborators
Hebei General Hospital, Zhongda Hospital, Anhui Provincial Hospital, The Second Hospital of Shandong University, Sun Yat-sen University, Chinese PLA General Hospital, Huadong Hospital, Tengzhou Central People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03882866
Brief Title
Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer
Official Title
3D-printed Template for Iodine-125 Seed Implantation Therapy in Patients With Locally Advanced Pancreatic Cancer: a Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
Hebei General Hospital, Zhongda Hospital, Anhui Provincial Hospital, The Second Hospital of Shandong University, Sun Yat-sen University, Chinese PLA General Hospital, Huadong Hospital, Tengzhou Central People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Iodine-125, Three-Dimensional Printing, Brachytherapy, template

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D-printed non-coplanar template
Arm Type
Experimental
Arm Description
3D-printed non-coplanar template is used in this group.
Arm Title
3D-printed coplanar template
Arm Type
Active Comparator
Arm Description
3D-printed coplanar template is used in this group.
Intervention Type
Procedure
Intervention Name(s)
3D-printed non-coplanar template
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
3D-printed coplanar template
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.
Time Frame
24 months
Title
Incidence of treatment-emergent toxicities of two treatment regimens in patients
Description
The toxicity criteria of the Radiation Therapy Oncology Group (RTOG) were applied to assess the acute and late adverse effects of irradiation.
Time Frame
24 months
Title
Quality of life of two treatment regimens in patients
Description
Quality of life will be evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)C30 Questionnaire.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongmin Wang, MD
Phone
0086-13901848333
Email
wzm0722@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qungang Shan, MD
Phone
0086-15989037568
Email
qungangshan@sjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongmin Wang, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weifu Lv
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yueyong Xiao, MD
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fujun Zhang, MD
Facility Name
Hebei General Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Wang, MD
Facility Name
Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinhe Guo, MD
Facility Name
The Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuliang Li, MD
Facility Name
Teng Zhou Central People's Hospital
City
Zaozhuang
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaixian Zhang, MD
Facility Name
Huadong Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhao

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer

We'll reach out to this number within 24 hrs