I125 Seed Implantation vs Stereotactic Radiotherapy for Pancreatic Cancer

NCT03964064 | Unknown

• 1 other identifier: BYSY-CKSI-PC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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 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.

Conditions

Pancreatic Cancer Non-resectable; Brachytherapy; Radiotherapy

Keywords

Pancreatic Cancer Non-resectable; I125 seed implantation; Stereotactic radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Local control rate，LCR

  3 years after the treatment

• Pain score

  1 years after the treatment

• Qol: Quality of Life Score of Tumor Patients

  3 years after the treatment

• Adverse reactions

  1 years after the treatment

Study Arms (2)

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

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.

Radiation: 3D-printing Template-assisted CT-guided I125 Seed Implantation

Interventions

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

I125 Seed Implantation

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.

Stereotactic Radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing 302 Hospital: collaborator
• Guangxi Ruikang Hospital: collaborator
• Tengzhou Central People's Hospital: collaborator

Study Sites (4)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

The fifth medical center of PLA general hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Guangxi Ruikang Hospital

Nanning, Guangxi, 530000, China

RECRUITING

Tengzhou Central People's Hospital

Tengzhou, Shandong, 277599, China

RECRUITING

Related Publications (17)

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• 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.

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• 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

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• 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

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  PMID: 25559415 RESULT

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Junjie Wang, Chairman

  Peking University Third Hospital

  STUDY CHAIR

• Fei Xu

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Xuezhang Duan, Director

  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

Central Study Contacts

Junjie Wang, Chairman

CONTACT

+860182264910; junjiewang_edu@sina.cn

Fei Xu

CONTACT

+8618511866032; xufeibysy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-randomized trial

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 28, 2019
• Study Start: June 11, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 1, 2022
• Last Updated: July 19, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)