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| Name | Class |
|---|---|
| Hebei General Hospital | OTHER |
| Zhongda Hospital | OTHER |
| Anhui Provincial Hospital | OTHER_GOV |
| The Second Hospital of Shandong University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D-printed non-coplanar template | Experimental | 3D-printed non-coplanar template is used in this group. |
|
| 3D-printed coplanar template | Active Comparator | 3D-printed coplanar template is used in this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-printed non-coplanar template | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence of treatment-emergent toxicities of two treatment regimens in patients |
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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:
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongmin Wang, MD | Contact | 0086-13901848333 | wzm0722@hotmail.com | |
| Qungang Shan, MD | Contact | 0086-15989037568 | qungangshan@sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhongmin Wang, MD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Recruiting | Hefei | Anhui | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| OTHER |
| Sun Yat-sen University | OTHER |
| Chinese PLA General Hospital | OTHER |
| Huadong Hospital | OTHER |
| Tengzhou Central People's Hospital | OTHER_GOV |
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|
| 3D-printed coplanar template | Procedure | 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. |
|
The toxicity criteria of the Radiation Therapy Oncology Group (RTOG) were applied to assess the acute and late adverse effects of irradiation.
| 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. | 24 months |
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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| Hebei General Hospital | Recruiting | Shijiazhuang | Hebei | China |
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| Zhongda Hospital | Recruiting | Nanjing | Jiangsu | China |
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| The Second Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
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| Teng Zhou Central People's Hospital | Recruiting | Zaozhuang | Shandong | China |
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| Huadong Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |