I125 Seed Implantation vs Stereotactic Radiotherapy for Pancreatic Cancer (Ckvssip)
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|ClinicalTrials.gov Identifier: NCT03964064|
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Non-resectable Brachytherapy Radiotherapy||Radiation: Stereotactic Radiotherapy Radiation: 3D-printing Template-assisted CT-guided I125 Seed Implantation||Not Applicable|
Radiation: Stereotactic Radiotherapy 1.1 Equipment: Accuray VSI Cyberknife stereotactic radiotherapy platform, simulated positioning CT machine, MR, positron emission computed tomography PET-CT, vacuum pad.
1.2 Radiotherapy localization: CT, MRI and PETCT were used to simulate localization.
1.3 Relevant Definitions of Tumor Targets CT, MRI, PET-CT fusion, combined with MRI location and PET-CT location image for sketching.
To delineate target areas and organs at risk. GTV: Combining localization and fusion images to delineate the tumors seen PTV = GTV + 0-10mm Dangerous organs: The stomach, duodenum, jejunum, ileum, colon, spinal cord and esophagus were delineated on the base sequence of CT plain scan.
The target area should be approved by at least one physician in charge or by a physician in charge.
1.4 Target volume radiation dose: According to the volume, location, organ function and other factors, the dosage of radiotherapy was determined. The range of BED value of radiotherapy was 80-100 when the distance between the tumor and gastrointestinal tract was more than 5 mm (alpha/beta=10) and 60-80 when the distance between the tumor and gastrointestinal tract was less than 5 mm (alpha/beta=10).
1.5 Normal Tissue Limit: Reference to TG101 Report
- CT-guided radioactive 125I seeds therapy with 3D printing template for pancreatic cancer 2.1 Preoperative planning 2.2 Design and fabrication of 3D-PNCT 2.3 125I seeds implantation: 3D-PNCT was placed on the surface of the patient's treatment area, and positioned with the help of the patient's outline features, laser lines, body surface positioning lines and template alignment reference lines.
The location of the template and the tumor is well repeated. If there are errors, the template should be adjusted in time. The insertion needle was percutaneously punctured to a predetermined depth through a template guide hole. During the puncture process, the puncture path was monitored by CT scanning and fine-tuned if necessary to avoid injuring nerves and blood vessels. Seeds implantation and CT scan were performed according to the preoperative plan to understand the distribution of seeds. During the operation, the implant needle should be added or reduced when necessary to ensure that the whole target area is adequately irradiated and the surrounding normal tissues are protected.
2.4 Postoperative dose assessment: CT scan was performed after operation, and the image was transmitted to BTPS for dose verification (Figure 3-4). The dosimetric parameters included tumor volume, D90, mPD, V100, V150 and V200.
After these treatments,to evaluate the clinical efficacy of stereotactic radiotherapy and ct-guided 125I seed therapy with 3D printing template in pancreatic cancer;In addition, the local control rate and side effects of ct-guided radioactive 125I particles in the treatment of pancreatic cancer lesions were explored, and the efficacy and safety of different doses of stereotactic radiotherapy were determined.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||non-randomized trial|
|Masking:||None (Open Label)|
|Official Title:||3D-printing Template-assisted CT-guided I125 Seed Implantation and Stereotactic Radiotherapy for Locally Advanced Pancreatic Cancer:A Prospective Multicenter Cohort Study|
|Actual Study Start Date :||June 11, 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 1, 2022|
Experimental: I125 Seed Implantation
3D-printing Template-assisted CT-guided I125 Seed Implantation Prescription dose: gtv140-160gy ctv100-140gy Particle activity: 0.4-0.5mCi
Radiation: Stereotactic Radiotherapy
GTV: Combining localization and fusion images to delineate the tumors seen PTV = GTV + 0-10mm Target volume radiation dose: The range of BED value of radiotherapy was 80-100 when the distance between the tumor and gastrointestinal tract was more than 5 mm (alpha/beta=10) and 60-80 when the distance between the tumor and gastrointestinal tract was less than 5 mm (alpha/beta=10).
Normal Tissue Limit: Reference to TG101 Report
Experimental: Stereotactic Radiotherapy
According to the tumor volume, location, organ function and other factors, the dosage of stereotactic directional radiotherapy was determined. The range of BED value of radiotherapy was 80-100 for tumors above 5 mm from gastrointestinal tract and 60-80 for tumors below 5 mm from gastrointestinal tract.
Radiation: 3D-printing Template-assisted CT-guided I125 Seed Implantation
CT-guided radioactive 125I particle therapy with 3D printing template for pancreatic cancer Preoperative planning Design and fabrication of 3D-PNCT Particle implantation Postoperative dose assessment: CT scan was performed after operation, and the image was transmitted to BTPS for dose verification . The dosimetric parameters included tumor volume, D90, mPD, V100, V150 and V200.
- Overall survival (OS) [ Time Frame: 3 years after the treatment ]The time from enrollment to death from any cause
- Progression-free survival (PFS) [ Time Frame: 3 years after the treatment ]the time interval of disease progression since the date of diagnosis
- Local control rate，LCR [ Time Frame: 3 years after the treatment ]patients free from the disease in neck during the follow-up time
- Pain score [ Time Frame: 1 years after the treatment ]The pain relief of patients before and after treatment was evaluated by digital scoring method
- Qol: Quality of Life Score of Tumor Patients [ Time Frame: 3 years after the treatment ]Quality of Life Score of Tumor Patients
- Adverse reactions [ Time Frame: 1 years after the treatment ]Adverse reactions during and after treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964064
|Contact: Junjie Wang, Chairmanfirstname.lastname@example.org|
|Contact: Fei Xuemail@example.com|
|Peking University Third Hospital||Recruiting|
|Beijing, Beijing, China, 100000|
|Contact: Junjie Wang, Chairman +8682264910 firstname.lastname@example.org|
|Contact: Fei Xu +8618511866032 email@example.com|
|Principal Investigator: Junjie Wang, Chairman|
|Sub-Investigator: Fei Xu|
|Sub-Investigator: Zhe Ji|
|The fifth medical center of PLA general hospital||Recruiting|
|Beijing, Beijing, China, 100000|
|Contact: Xuezhang Duan, director +8613621386161 firstname.lastname@example.org|
|Principal Investigator: Xuezhang Duan|
|Sub-Investigator: Jing Sun|
|Guangxi Ruikang Hospital||Recruiting|
|Nanning, Guangxi, China, 530000|
|Contact: Zuping Lian, director +8613978806107 email@example.com|
|Principal Investigator: Zuping Lian, director|
|Tengzhou Central People's Hospital||Recruiting|
|Tengzhou, Shandong, China, 277599|
|Contact: Kaixian Zhang, director +8613563200960 firstname.lastname@example.org|
|Principal Investigator: Kaixian Zhang, director|
|Study Chair:||Junjie Wang, Chairman||Peking University Third Hospital|
|Principal Investigator:||Fei Xu||Peking University Third Hospital|
|Study Director:||Xuezhang Duan, Director||The fifth medical center of PLA general hospital|
|Study Director:||Kaixian Zhang, Director||Tengzhou Central People's Hospital|
|Study Director:||Zuping Lian, Director||Guangxi Ruikang Hospital|
|Study Director:||Zhe Ji||Peking University Third Hospital|
|Study Director:||Jing Sun||The fifth medical center of PLA general hospital|