Status:
UNKNOWN
Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1
Lead Sponsor:
Changhai Hospital
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study is to investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare the efficacy of gemcitabine plus nab-pa...
Detailed Description
This research study is a Phase II clinical trial that investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03777462
Start Date
April 1 2019
End Date
December 31 2023
Last Update
September 1 2023
Active Locations (1)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433