Randomized Phase 3 Trial Comparing Upfront Surgery versus Neoadjuvant modified FOLFIRINOX in Patients with Resectable Pancreatic Cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0007327
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 314
1. The subject may provide signed subject consent, including compliance with the requirements and restrictions described in the Informed Consent Form (ICF) and this clinical trial protocol.
2. From at least 19 years of age inclusive, at study entry.
3. Has cytological or histological confirmed diagnosis of pancreatic cancer.
4. participant with resectable pancreatic cancer according to NCCN criteria without prior chemotherapy (determined by CT, MRI, or PET-CT results, borderline resectable pancreatic cancer is not included)
5. Have a performance status of 0 or 1 on the ECOG performance scale
6. weight > 30 kg
7. Normal organ and bone marrow function
- platelet = 100 x 109/L, Absolute neutrophil count = 1.5 x 109/L and emoglobin > 9 g/dL(Blood transfusion is allowed if it is 7 days before screening)
- Creatinine <1.5 x ULN
- Total bililubin = 2 x ULN
- ALT and AST = 2.5 x
8. The subject is willing and able to comply with the clinical test protocol during the trial period, including administration and scheduled visits and examinations, including follow-up.
9. The subject has no non-melanoma skin cancer, cervical intraepithelial carcinoma, localized prostate cancer, papillary thyroid cancer, or other malignant disease, except for all other cancers that have been previously treated for the purpose of cure for more than 5 years without evidence of recurrence.
1. has a medical or psychiatric condition that threatens participant’s ability to provide consent or to comply with the protocol, or a history of non-compliance.
2. has an obstructed gastrointestinal tract.
3. has active gastrointestinal bleeding.
4. has had a myocardial infarction within 6 months prior to administration of the test drug and has other clinically significant heart disease(unstable angina, congestive heart failure or uncontrolled hypertension)
5. has the opinion that participant’s participation in the test is undesirable or has a rationale of severe or uncontrolled systemic disease or pathogenesis that threatens protocol compliance.
6. adenosquamous carcinoma and neuroendocrine tumor are excluded
7. has a history of another primary malignancy except for the following.
a. was treated for curative purpose, had no known active disease for at least 5 years prior to the first IP administration, and has a malignant tumor with a low potential risk for recurrence.
b. had no evidence of disease and had properly treated nonmelanoma skin cancer or malignant melanoma.
c. had no evidence of disease and had properly treated carcinoma in situ.
d. had no evidence of disease and had properly treated prostate cancer or papillary thyroid carcinoma
8. is pregnant or breastfeeding, or (male or female) has no intention to use effective contraception from screening to 6 months after the last administration of chemotherapy after surgery.
9. is known to be allergic or hypersensitive to any of the test drugs or to any of the test drug additives.
10. judges him/herself that participant is not suitable for his/her participation in the study and it is unlikely that participant will comply with the test procedures, restrictions and requirements.
11. is being administered prohibited drugs according to domestic approvals.
12. has an active infection requiring systemic therapy.
13. has had or is currently suffering from uncontrolled HIV, hepatitis B (HBV DNA < 2000 IU/mL can be registered for chronic hepatitis B or HBV carrier) or hepatitis C.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-Free Survival
- Secondary Outcome Measures
Name Time Method Overall Survival;toxicity(safety) profiles by NCI-CTCAE v5