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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
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 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.
Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGChinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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.
Time frame: 24 months
Overall Survival (OS)
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
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.
Time frame: 24 months
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.
Time frame: 24 months
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Hebei General Hospital
Shijiazhuang, Hebei, China
RECRUITINGZhongda Hospital
Nanjing, Jiangsu, China
RECRUITINGThe Second Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGTeng Zhou Central People's Hospital
Zaozhuang, Shandong, China
RECRUITINGHuadong Hospital
Shanghai, Shanghai Municipality, China
RECRUITING