Status:
RECRUITING
mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients
Lead Sponsor:
Sun Yat-sen University
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
Although FOLFIRINOX regimen was recently presented to be effective as adjuvant chemotherapy for resectable pancreatic cancer in selected patients who have good physical condition, there is still insuf...
Detailed Description
This is a phase II study. Patients with resectable pancreatic carcinoma will receive adjuvant chemotherapy of FOLFIRINOX for 6 months. Primary endpoint is the disease free survival. Secondary endpoin...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the pancreas without distant metastases.
- Receive radical resection of pancreatic cancer
- No prior cytostatic chemotherapy
- Female and male patients \> 18 and \<=79 years using contraception
- ECOG ≤ 1
- Patient has adequate bone marrow and organ function
- Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L Platelets ≥ 90 x 109/L Hemoglobin ≥ 90 g/L
- Patient has adequate liver function AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) Serum bilirubin ≤ 1.2 x ULN Creatinine ≤ 1.25 times ULN
- Good compliance
- Written informed consent
Exclusion
- Pregnant or lactating women
- Distant metastasis.
- Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
- Refuse to take appropriate contraceptive measures (including male patients).
- Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
- Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases.
- Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ).
- Psychiatric illness that would prevent the patient from giving informed consent.
- Patient is concurrently using other antineoplastic agent
- Patient has used investigational antineoplastic agent within 4 weeks prior to entry.
- Known HIV-positivity.
- No history of chronic diarrhea, nausea or vomit.
- No ≥ grade 2 sensory peripheral neuropathy.
- A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina.
- Infectious disease or inflammation with body temperature ≥ 38 ℃.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04084496
Start Date
September 1 2019
End Date
December 31 2025
Last Update
May 30 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060