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2019-03-28
2021-06-30
2021-09-30
220
NCT03882866
Ruijin Hospital
Ruijin Hospital
INTERVENTIONAL
Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-03-19 | N/A | 2020-02-05 |
2019-03-19 | N/A | 2020-02-06 |
2019-03-20 | N/A | 2020-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 3D-printed non-coplanar template 3D-printed non-coplanar template is used in this group. | PROCEDURE: 3D-printed non-coplanar template
|
| ACTIVE_COMPARATOR: 3D-printed coplanar template 3D-printed coplanar template is used in this group. | PROCEDURE: 3D-printed coplanar template
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Zhongmin Wang, MD Phone Number: 0086-13901848333 Email: wzm0722@hotmail.com |
Study Contact Backup Name: Qungang Shan, MD Phone Number: 0086-15989037568 Email: qungangshan@sjtu.edu.cn |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
