Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer

Shanghai Jiao Tong University

Status: Unknown

Conditions: Pancreatic Cancer

Treatments: Procedure: 3D-printed non-coplanar template; Procedure: 3D-printed coplanar template

Study type: Interventional

Funder types: Other

Identifiers

NCT03882866

2018clinicethicreview215

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

3D-printed non-coplanar template

Experimental group

Description:

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

Treatment:

Procedure: 3D-printed non-coplanar template

3D-printed coplanar template

Active Comparator group

Description:

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

Treatment:

Procedure: 3D-printed coplanar template