Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03882866
• Other study ID #: 2018clinicethicreview215
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2020
• Source: Ruijin Hospital
• Contact: Zhongmin Wang, MD
• Phone: 0086-13901848333
• Email: wzm0722[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Anhui Provincial Hospital	Hefei	Anhui
China	The Second Hospital of Shandong University	Jinan	Shandong
China	Zhongda Hospital	Nanjing	Jiangsu
China	Huadong Hospital	Shanghai	Shanghai
China	Hebei General Hospital	Shijiazhuang	Hebei
China	Teng Zhou Central People's Hospital	Zaozhuang	Shandong

Sponsors (9)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.	24 months
Secondary	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.	24 months
Secondary	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.	24 months