Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1

Launched by CHANGHAI HOSPITAL · Dec 14, 2018

Keywords

ClinConnect Summary

This clinical trial, called the Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1, is exploring new treatment options for patients with a specific type of pancreatic cancer known as borderline resectable pancreatic adenocarcinoma. The study aims to find out if combining chemotherapy with a special type of radiation therapy called SBRT (Stereotactic Body Radiation Therapy) can help patients more than just chemotherapy alone. The trial will also compare two different chemotherapy combinations to see which one works better when used with SBRT.

To be eligible for this trial, participants must be between 18 and 80 years old, have a confirmed diagnosis of pancreatic cancer that is borderline resectable, and have not received any previous chemotherapy or radiation treatments. People with severe heart or lung issues, or those who have had other cancers recently, cannot participate. Those who join the study can expect to receive either the chemotherapy treatment or the combination of chemotherapy and radiation, with regular check-ups to monitor their health. It’s important for potential participants to understand that they will need to provide informed consent before joining and that their health will be closely monitored throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age≥18 years old and ≤80 years old;
• • Histological proven pancreatic adenocarcinoma;
• • Borderline resectable pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines;
• • No prior chemotherapy or radiotherapy;
• • ECOG of 0 or 1;
• • Routine blood test: absolute neutrophil count\>1500/mm3, platelet\>100000/mm3;
• • Normal liver function: serum total bilirubin≤2.0mg/dl, ALT and AST\<2.5 times of the upper limit of normal value;
• • Normal kidney function: serum creatinine\<1.5 times of the upper limit of normal value or creatinine clearance rate\>45ml/min;
• • No severe comorbidities.
• Exclusion Criteria:
• • Metastatic pancreatic cancer;
• • Patients who had surgeries, chemotherapy or other treatments before inclusion;
• • Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure;
• • Confirmed other cancer within 5 years;
• • Pregnant women or lactating women;
• • Patients enrolled in other clinical trials or incompliant of regular follow up;
• • Patients who did not provide an informed consent.