Clinical trial NCT03882866: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Iodine-125
Three-Dimensional Printing
Brachytherapy
template
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Hebei General Hospital
name: Zhongda Hospital
name: Anhui Provincial Hospital
name: The Second Hospital of Shandong University
name: Sun Yat-sen University
name: Chinese PLA General Hospital
name: Huadong Hospital
name: Tengzhou Central People's Hospital
First posted: 2019-03-20
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 24 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 24 months
measure: Incidence of treatment-emergent toxicities of two treatment regimens in patients
timeFrame: 24 months
measure: Quality of life of two treatment regimens in patients
timeFrame: 24 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Zaozhuang
country: China
facility: Teng Zhou Central People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Huadong Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Zhongmin Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: