Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer

Not Applicable

• Conditions: Pancreatic Cancer
• Interventions: Procedure: 3D-printed non-coplanar template; Procedure: 3D-printed coplanar template

• Registration Number: NCT03882866
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-20
• Study Start: 2019-03-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent toxicities of two treatment regimens in patients	24 months	The toxicity criteria of the Radiation Therapy Oncology Group (RTOG) were applied to assess the acute and late adverse effects of irradiation.
Overall Survival (OS)	24 months	OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.
Quality of life of two treatment regimens in patients	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.

Trial Locations

Locations (8)

The Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

Teng Zhou Central People's Hospital; 🇨🇳 Zaozhuang, Shandong, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Huadong Hospital; 🇨🇳 Shanghai, Shanghai, China

Hebei General Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China