I125 Seed Implantation vs Stereotactic Radiotherapy for Pancreatic Cancer

Last updated: July 18, 2019
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Cancer

Cancer Treatment

Treatment

N/A

Clinical Study ID

NCT03964064
BYSY-CKSI-PC
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 18-80 years old;

  • Pathologically diagnosed pancreatic cancer patients;Follow-up treatment is inaccordance with the NCCN2019 guidelines for standard treatment.

  • Clinical MDT discussion, for the unresectable locally advanced pancreatic cancer, AJCCversion 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 ofthe superior mesenteric artery.The pancreatic body tail superior mesenteric artery orceliac tumor invasion more than 180 °;The tumor invaded the abdominal trunk and abdominalaorta. Venous invasion: Tumor invasion or embolization (tumor thrombus or thrombus) of the head and neck of thepancreas leads to unresectable superior mesenteric vein or portal vein reconstruction;Thetumor invaded the proximal end jejunal drainage branch of most superior mesentericveins.The invasion or embolization of a tumor in the tail of the pancreas (thrombus orthrombus) leads to the unresectable reconstruction of the superior mesenteric vein orportal 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.

Exclusion

Exclusion Criteria:

  • Non-locally advanced pancreatic cancer.

  • Participated in other drug clinical trials within four weeks;There was a history ofbleeding, and any bleeding event with severe grade of CTCAE5.0 or above occurredwithin 4 weeks before screening;

  • Screening of patients with known central nervous system metastasis or a history ofcentral nervous system metastasis.

  • Patients with hypertension who cannot obtain good control by single antihypertensivedrug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg);Having a history of unstable angina pectoris;Patients newly diagnosed withangina within 3 months before screening or myocardial infarction within 6 monthsbefore screening;Arrhythmia (including QTcF: 450ms in male and 470ms in female)requires long-term use of anti-arrhythmia drugs and New York heart association gradeII cardiac dysfunction;

  • Long-term unhealed wounds or incomplete fracture healing;

  • Imaging showed that the tumor had invaded important blood vessels or the researchersjudged that the patient's tumor had a very high possibility to invade important bloodvessels during the treatment and cause fatal bleeding;

  • Coagulation function abnormalities, have bleeding tendency;Patients treated withanticoagulants or vitamin K antagonists such as warfarin, heparin or theiranalogues;The use of low-dose warfarin (1mg oral, once daily) or low-dose aspirin (nomore than 100mg daily) for preventive purposes is permitted on the premise that theinternational standardized ratio of prothrombin time (INR) is 1.5;

  • Screening for the occurrence of hyperactive/venous thrombosis events in the first 6months, such as cerebrovascular accidents (including temporary ischemic attack), deepvein thrombosis (except for venous thrombosis caused by intravenous catheterization inthe early stage of chemotherapy, which was determined by the researchers to haverecovered) and pulmonary embolism, etc.

  • Thyroid function was abnormal in the past and could not be kept within the normalrange even in the case of drug treatment.

  • Attending has a history of psychotropic drug abuse, and can't attend or has mentaldisorder;

  • 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 ofpatients or patients completed the research associated with disease.

Study Design

Total Participants: 100
Study Start date:
June 11, 2019
Estimated Completion Date:
May 01, 2022

Study Description

  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.

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • The fifth medical center of PLA general hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Guangxi Ruikang Hospital

    Nanning, Guangxi 530000
    China

    Active - Recruiting

  • Tengzhou Central People's Hospital

    Tengzhou, Shandong 277599
    China

    Active - Recruiting

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