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| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
| Guangxi Ruikang Hospital | OTHER |
| Tengzhou Central People's Hospital | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I125 Seed Implantation | Experimental | 3D-printing Template-assisted CT-guided I125 Seed Implantation Prescription dose: gtv140-160gy ctv100-140gy Particle activity: 0.4-0.5mCi |
|
| Stereotactic Radiotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiotherapy | Radiation | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Arterial invasion:
The pancreatic head and neck tumor invasion of pancreas superior mesenteric artery exceed 180 °;More than 180 ° celiac tumor invasion;The tumor invaded the first jejunal branch of the superior mesenteric artery.The pancreatic body tail superior mesenteric artery or celiac tumor invasion more than 180 °;The tumor invaded the abdominal trunk and abdominal aorta.
Venous invasion:
Tumor invasion or embolization (tumor thrombus or thrombus) of the head and neck of the pancreas leads to unresectable superior mesenteric vein or portal vein reconstruction;The tumor invaded the proximal end jejunal drainage branch of most superior mesenteric veins.The invasion or embolization of a tumor in the tail of the pancreas (thrombus or thrombus) leads to the unresectable reconstruction of the superior mesenteric vein or portal vein.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junjie Wang, Chairman | Contact | +860182264910 | junjiewang_edu@sina.cn | |
| Fei Xu | Contact | +8618511866032 | xufeibysy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junjie Wang, Chairman | Peking University Third Hospital | Study Chair |
| Fei Xu | Peking University Third Hospital | Principal Investigator |
| Xuezhang Duan, Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25333036 | Background | 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. | |
| 15122610 | Background | 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. |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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non-randomized trial
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|
| 3D-printing Template-assisted CT-guided I125 Seed Implantation | Radiation | 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. |
|
| 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 |
| Beijing 302 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 | Beijing 302 Hospital | Study Director |
| The fifth medical center of PLA general hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
|
| Guangxi Ruikang Hospital | Recruiting | Nanning | Guangxi | 530000 | China |
|
| Tengzhou Central People's Hospital | Recruiting | Tengzhou | Shandong | 277599 | China |
|
| 16002845 | Background | 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. |
| 19273710 | Background | 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. |
| 15001240 | Background | 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. |
| 16168826 | Background | 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. |
| 18395362 | Background | 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. |
| 25538019 | Background | 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. |
| 2808054 | Background | 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. |
| Background | 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. |
| 16677499 | Background | 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. |
| Background | 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. |
| Background | 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 |
| Background | 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. |
| Background | 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. |
| Background | 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. |
| 25559415 | Result | 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. |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |