Tokyo, Aug. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062610) titled 'Prospective observational study of preoperative algorithmic treatment for borderline resectable pancreatic cancer' on Aug. 24.
Study Type:
Observational
Primary Sponsor:
Institute - Tokai University
Condition:
Condition - Borderline resectable pancreatic cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to establish an induction chemotherapy response guided treatment algorithm for borderline resectable pancreatic cancer with arterial and/or portal venous involvement. By selecting patients who are most likely to benefit from surgery while continuing nonsurgical treatment in others, we will evaluate whether this algorithm improves overall survival compared with conventional treatment. Outcomes will include protocol completion, overall and recurrence free survival, and the 1year recurrence rate.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Patients diagnosed with pancreatic cancer by histological, cytological, or imaging examination and classified by multidetector-row computed tomography as having borderline resectable pancreatic cancer with arterial and/or portal venous involvement according to the NCCN Guidelines Version 1.2020 and the Japanese Clinical Practice Guidelines for Pancreatic Cancer 2022.
2. Patients who have not received prior treatment for pancreatic cancer.
3. Eastern Cooperative Oncology Group performance status of 0 or 1.
4. Age 18 years or older and younger than 80 years at the time of informed consent.
5. Adequate major organ function based on the most recent laboratory tests performed within 14 days before enrollment: white blood cell count of 12,000/mm3 or less; neutrophil count of 1,500/mm3 or higher; hemoglobin level of 9.0 g/dL or higher; platelet count of 100,000/mm3 or higher; total bilirubin level below 2.0 mg/dL (3.0 mg/dL or lower in patients undergoing biliary drainage); serum creatinine level of 1.5 mg/dL or lower; and AST and ALT levels no higher than 2.5 times the institutional upper limit of normal.
6. Written informed consent provided by the patient before enrollment.
Key exclusion criteria - 1. History of severe drug hypersensitivity or drug allergy.
2. History of malignancy, except for malignancies without recurrence for at least 5 years, endoscopically cured intramucosal cancer, curatively treated cervical cancer, or basal cell or squamous cell carcinoma of the skin.
3. Active infection.
4. Grade 2 or higher peripheral sensory neuropathy.
5. History of interstitial pneumonia or pulmonary fibrosis.
6. Uncontrolled ascites or pleural effusion.
7. Current treatment with atazanavir sulfate.
8. Uncontrolled diabetes mellitus.
9. Uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmia.
10. History or presence of a serious neurological or psychiatric disorder.
11. Diarrhea, including increased stool frequency or watery stools.
12. Pregnancy, breastfeeding, intention to become pregnant, or unwillingness of female or male participants to use contraception during the study and for 180 days after the last treatment.
13. Active hepatitis B.
14. Regarding UGT1A1*6 and *28 gene polymorphisms, have either of them as homozygotes (UGT1A1*6/*6, UGT1A1*28/*28) or both as heterozygotes (UGT1A1*6/*28) Case
Target Size - 25
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 05 Month 01 Day
Date of IRB - 2025 Year 05 Month 20 Day
Anticipated trial start date - 2025 Year 05 Month 21 Day
Last follow-up date - 2030 Year 02 Month 04 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071657
Disclaimer: Curated by HT Syndication.
