Pancreatic Cancer Non-resectableCkvssipNCT03964064
I125 Seed Implantation vs Stereotactic Radiotherapy for Pancreatic Cancer
A study testing Stereotactic Radiotherapy and 3D-printing Template-assisted CT-guided I125 Seed Implantation in people with Pancreatic Cancer Non-resectable and Brachytherapy, run by Peking University Third Hospital at 4 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer Non-resectable, Brachytherapy, Radiotherapy
- What is being tested?
- Stereotactic Radiotherapy and 3D-printing Template-assisted CT-guided I125 Seed Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesChina
- Study dates
- 11 Jun 2019to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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:
Show all 12Show fewer
- 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.
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Junjie Wang, Chairman, +8682264910, junjiewang_edu@sina.cn
Fei Xu, +8618511866032, xufeibysy@163.com
- Recruiting
The fifth medical center of PLA general hospital
Beijing, Beijing Municipality, 100000
Xuezhang Duan, director, +8613621386161, 13621386161@163.com
Xuezhang Duan
- Recruiting
Guangxi Ruikang Hospital
Nanning, Guangxi, 530000
Zuping Lian, director, +8613978806107, zupinglian@sina.com
Zuping Lian, director
- Recruiting
Tengzhou Central People's Hospital
Tengzhou, Shandong, 277599
Kaixian Zhang, director, +8613563200960, kaixianzhang@aliyun.com
Kaixian Zhang, director
About this study
Official title: 3D-printing Template-assisted CT-guided I125 Seed Implantation and Stereotactic Radiotherapy for Locally Advanced Pancreatic Cancer:A Prospective Multicenter Cohort Study
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.
Read the detailed description
- 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.
- Being tested
- Stereotactic Radiotherapy, 3D-printing Template-assisted CT-guided I125 Seed Implantation
- Keywords
- Pancreatic Cancer Non-resectable, I125 seed implantation, Stereotactic radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiotherapyRadiation
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
3D-printing Template-assisted CT-guided I125 Seed ImplantationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Stereotactic Radiotherapy |
| 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. Receives: Radiation: 3D-printing Template-assisted CT-guided I125 Seed Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The time from enrollment to death from any cause
Measured: 3 years after the treatment
Progression-free survival (PFS)
the time interval of disease progression since the date of diagnosis
Measured: 3 years after the treatment
Secondary outcomes (4)
Local control rate，LCR
patients free from the disease in neck during the follow-up time
Measured: 3 years after the treatment
Pain score
The pain relief of patients before and after treatment was evaluated by digital scoring method
Measured: 1 years after the treatment
Qol: Quality of Life Score of Tumor Patients
Quality of Life Score of Tumor Patients
Measured: 3 years after the treatment
Adverse reactions
Adverse reactions during and after treatment
Measured: 1 years after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start11 Jun 2019
- Primary completion31 May 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer Non-resectableStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomized trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital, Guangxi Ruikang Hospital, Tengzhou Central People's Hospital
- Responsible party
- Sponsor
- Investigators
- Junjie Wang, Chairman, Study chair, Peking University Third HospitalFei Xu, Principal investigator, Peking University Third HospitalXuezhang Duan, Director, Study director, Beijing 302 HospitalKaixian Zhang, Director, Study director, Tengzhou Central People's HospitalZuping Lian, Director, Study director, Guangxi Ruikang HospitalZhe Ji, Study director, Peking University Third HospitalJing Sun, Study director, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964064
- Sponsor's protocol ID
- BYSY-CKSI-PC
- Acronym
- Ckvssip
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25333036Wagner 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.
PubMed 15122610Willett 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.
PubMed 16002845Iacobuzio-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.
PubMed 19273710Koong 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.
PubMed 15001240Koong 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.
PubMed 16168826Schellenberg 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.
PubMed 18395362Herman 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.
PubMed 25538019Peretz 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.
PubMed 2808054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.
PubMed 16677499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．
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-printing Template-assisted CT-guided I125 Seed Implantation and Stereotactic Radiotherapy for Locally Advanced Pancreatic Cancer:A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT03964064
- Acronym / sponsor ID
- Ckvssip / BYSY-CKSI-PC
- Keywords
- Pancreatic Cancer Non-resectable, I125 seed implantation, Stereotactic radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital, Guangxi Ruikang Hospital, Tengzhou Central People's Hospital
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-randomized trial
| Arm | Type | Receives |
|---|---|---|
| I125 Seed Implantation | Experimental | Radiation: Stereotactic Radiotherapy3D-printing Template-assisted CT-guided I125 Seed Implantation Prescription dose: gtv140-160gy ctv100-140gy Particle activity: 0.4-0.5mCi |
| Stereotactic Radiotherapy | Experimental | Radiation: 3D-printing Template-assisted CT-guided I125 Seed ImplantationAccording 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- 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.
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic RadiotherapyGTV: 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 | Radiation | I125 Seed Implantation |
| 3D-printing Template-assisted CT-guided I125 Seed ImplantationCT-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. | Radiation | Stereotactic Radiotherapy |
Primary outcome
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
4 secondary outcomes
Local control rate，LCR
Time frame: 3 years after the treatment
Pain score
Time frame: 1 years after the treatment
Qol: Quality of Life Score of Tumor Patients
Time frame: 3 years after the treatment
Adverse reactions
Time frame: 1 years after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Background: PubMed 25333036Chen 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.
- Background: PubMed 15122610Wagner 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.
- Background: PubMed 16002845Willett 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.
- Background: PubMed 19273710Iacobuzio-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.
- Background: PubMed 15001240Koong 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.
- Background: PubMed 16168826Koong 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.
- Background: PubMed 18395362Schellenberg 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.
- Background: PubMed 25538019Herman 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.
- Background: PubMed 2808054Peretz 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．
- Background: PubMed 16677499Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junjie Wang, Chairman study chair
Peking University Third Hospital
Fei Xu principal investigator
Peking University Third Hospital
Xuezhang Duan, Director study director
Beijing 302 Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiotherapy and 3D-printing Template-assisted CT-guided I125 Seed Implantation in people with Pancreatic Cancer Non-resectable and Brachytherapy, run by Peking University Third Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junjie Wang, Chairman (+860182264910, junjiewang_edu@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 3 years after the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03964064, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.