I125 Seed Implantation Vs Stereotactic Radiotherapy For Pancreatic Cancer

Study Overview

I125 Seed Implantation vs Stereotactic Radiotherapy for Pancreatic Cancer

Data of 100 patients with locally advanced pancreatic cancer who received stereotactic radiotherapy or ct-guided radioactive 125I seed implantation in the multicenter of the research group from July 2019 to June 2021 were collected, as well as follow-up data.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.

1. 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 2. 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.

Pancreatic Cancer Non-resectable
Brachytherapy
Radiotherapy

RADIATION: Stereotactic Radiotherapy
RADIATION: 3D-printing Template-assisted CT-guided I125 Seed Implantation

BYSY-CKSI-PC

Study Record Dates

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
First Submitted 2019-05-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-07-18
First Submitted that Met QC Criteria 2019-05-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-07-19
First Posted (ACTUAL) 2019-05-28	Results First Posted N/A	Last Verified 2019-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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
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 fo	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 w

Participant Group/Arm

Intervention/Treatment

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

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 fo

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 w

Primary Outcome Measures	Measure Description	Time Frame
Overall survival (OS)	The time from enrollment to death from any cause	3 years after the treatment
Progression-free survival (PFS)	the time interval of disease progression since the date of diagnosis	3 years after the treatment

Secondary Outcome Measures	Measure Description	Time Frame
Local control rate，LCR	patients free from the disease in neck during the follow-up time	3 years after the treatment
Pain score	The pain relief of patients before and after treatment was evaluated by digital scoring method	1 years after the treatment
Qol: Quality of Life Score of Tumor Patients	Quality of Life Score of Tumor Patients	3 years after the treatment
Adverse reactions	Adverse reactions during and after treatment	1 years after the treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Junjie Wang, Chairman

Phone Number: +860182264910

Email: junjiewang_edu@sina.cn

Study Contact Backup

Name: Fei Xu

Phone Number: +8618511866032

Email: xufeibysy@163.com

Participation Criteria

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:

Age: 18-80 years old;
Pathologically diagnosed pancreatic cancer patients;Follow-up treatment is in accordance with the NCCN2019 guidelines for standard treatment.
Clinical MDT discussion, for the unresectable locally advanced pancreatic cancer, AJCC version 8 pancreatic cancer stage T4N0M0

ECOG physical condition score: 0-1, Karnofsky score 60, able to withstand puncture;
Expected survival 3 months;
Good function of main organs, no severe hypertension, diabetes and heart disease.
Signed informed consent;
Has a good compliance, families agree to accept the survival follow-up.

Non-locally advanced pancreatic cancer.
Participated in other drug clinical trials within four weeks;There was a history of bleeding, and any bleeding event with severe grade of CTCAE5.0 or above occurred within 4 weeks before screening;
Screening of patients with known central nervous system metastasis or a history of central nervous system metastasis.
Patients with hypertension who cannot obtain good control by single antihypertensive drug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg);Having a history of unstable angina pectoris;Patients newly diagnosed with angina within 3 months before screening or myocardial infarction within 6 months before screening;Arrhythmia (including QTcF: 450ms in male and 470ms in female) requires long-term use of anti-arrhythmia drugs and New York heart association grade II cardiac dysfunction;
Long-term unhealed wounds or incomplete fracture healing;
Imaging showed that the tumor had invaded important blood vessels or the researchers judged that the patient's tumor had a very high possibility to invade important blood vessels during the treatment and cause fatal bleeding;
Coagulation function abnormalities, have bleeding tendency;Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues;The use of low-dose warfarin (1mg oral, once daily) or low-dose aspirin (no more than 100mg daily) for preventive purposes is permitted on the premise that the international standardized ratio of prothrombin time (INR) is 1.5;
Screening for the occurrence of hyperactive/venous thrombosis events in the first 6 months, such as cerebrovascular accidents (including temporary ischemic attack), deep vein thrombosis (except for venous thrombosis caused by intravenous catheterization in the early stage of chemotherapy, which was determined by the researchers to have recovered) and pulmonary embolism, etc.
Thyroid function was abnormal in the past and could not be kept within the normal range even in the case of drug treatment.
Attending has a history of psychotropic drug abuse, and can't attend or has mental disorder;
Always half a year after abdominal tumor lesion radiation;
Immunodeficiency disease, or has other acquired, congenital immunodeficiency disease, or has a history of organ transplantation;
Judgment according to the researchers, there is serious to endanger the safety of patients or patients completed the research associated with disease.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Beijing 302 Hospital
Guangxi Ruikang Hospital
Tengzhou Central People's Hospital

Investigators

STUDY_CHAIR: Junjie Wang, Chairman, Peking University Third Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Chen W, Zheng R, Zhang S, Zhao P, Zeng H, Zou X. Report of cancer incidence and mortality in China, 2010. Ann Transl Med. 2014 Jul;2(7):61. doi: 10.3978/j.issn.2305-5839.2014.04.05.
Wagner M, Redaelli C, Lietz M, Seiler CA, Friess H, Buchler MW. Curative resection is the single most important factor determining outcome in patients with pancreatic adenocarcinoma. Br J Surg. 2004 May;91(5):586-94. doi: 10.1002/bjs.4484.
Willett CG, Czito BG, Bendell JC, Ryan DP. Locally advanced pancreatic cancer. J Clin Oncol. 2005 Jul 10;23(20):4538-44. doi: 10.1200/JCO.2005.23.911.
Iacobuzio-Donahue CA, Fu B, Yachida S, Luo M, Abe H, Henderson CM, Vilardell F, Wang Z, Keller JW, Banerjee P, Herman JM, Cameron JL, Yeo CJ, Halushka MK, Eshleman JR, Raben M, Klein AP, Hruban RH, Hidalgo M, Laheru D. DPC4 gene status of the primary carcinoma correlates with patterns of failure in patients with pancreatic cancer. J Clin Oncol. 2009 Apr 10;27(11):1806-13. doi: 10.1200/JCO.2008.17.7188. Epub 2009 Mar 9.
Koong AC, Le QT, Ho A, Fong B, Fisher G, Cho C, Ford J, Poen J, Gibbs IC, Mehta VK, Kee S, Trueblood W, Yang G, Bastidas JA. Phase I study of stereotactic radiosurgery in patients with locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2004 Mar 15;58(4):1017-21. doi: 10.1016/j.ijrobp.2003.11.004.
Koong AC, Christofferson E, Le QT, Goodman KA, Ho A, Kuo T, Ford JM, Fisher GA, Greco R, Norton J, Yang GP. Phase II study to assess the efficacy of conventionally fractionated radiotherapy followed by a stereotactic radiosurgery boost in patients with locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):320-3. doi: 10.1016/j.ijrobp.2005.07.002.
Schellenberg D, Goodman KA, Lee F, Chang S, Kuo T, Ford JM, Fisher GA, Quon A, Desser TS, Norton J, Greco R, Yang GP, Koong AC. Gemcitabine chemotherapy and single-fraction stereotactic body radiotherapy for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):678-86. doi: 10.1016/j.ijrobp.2008.01.051. Epub 2008 Apr 18.
Herman JM, Chang DT, Goodman KA, Dholakia AS, Raman SP, Hacker-Prietz A, Iacobuzio-Donahue CA, Griffith ME, Pawlik TM, Pai JS, O'Reilly E, Fisher GA, Wild AT, Rosati LM, Zheng L, Wolfgang CL, Laheru DA, Columbo LA, Sugar EA, Koong AC. Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma. Cancer. 2015 Apr 1;121(7):1128-37. doi: 10.1002/cncr.29161. Epub 2014 Dec 23.
Peretz T, Nori D, Hilaris B, Manolatos S, Linares L, Harrison L, Anderson LL, Fuks Z, Brennan MF. Treatment of primary unresectable carcinoma of the pancreas with I-125 implantation. Int J Radiat Oncol Biol Phys. 1989 Nov;17(5):931-5. doi: 10.1016/0360-3016(89)90138-7.
王俊杰，黄毅，冉宝强．放射性粒子组织间种植治疗肿瘤临床应用的可行性IJ]．中国微创外科杂志．2003．3：148．149．
Zhang FJ, Wu PH, Zhao M, Huang JH, Fan WJ, Gu YK, Liu J, Zhang L, Lu MJ. [CT guided radioactive seed 125I implantation in treatment of pancreatic cancer]. Zhonghua Yi Xue Za Zhi. 2006 Jan 24;86(4):223-7. Chinese.
王忠敏，陈克敏，金冶宁等.CT 引导下植入 125I 粒子放射性粒子治疗胰腺癌的疗效观察[J].中国肿瘤临床，2009,36:65-69.
朱永强，陈俊英，郭剑锋.CT 引导下 125I 粒子植入治疗晚期胰腺癌的临床疗效分析[J]. 介入放射学杂志，2011,20（4）：283-286
盖宝东，舒振波，丁大勇等．125I放射性粒子治疗胰腺癌[J]．中国普外基础与临床杂志．2007．14(5)：582-583．
熊炯忻，黄鹏，王春友．125I粒子组织间植入治疗局部进展期胰腺癌42例[J]．中国肿瘤临床，2005．32(23)：1352一1355．
李振家，肖连祥，胰腺癌CT导引近距离放疗穿刺入路选择技术及策略[J]．当代医学． 2009．1 5(29)：543-546．
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.

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