RecruitingPhase 2NCT04084496

mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

A Phase II Study With mFOLFIRINOX as Adjuvent Chemotherapy for Resectable Pancreas Carcinoma

Sponsor

Sun Yat-sen University

Enrollment

80 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

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 insufficient evidence on this regimen in treating resectable pancreatic cancer patients in China. Since for many tumors, different races may show different responses to the same regimen, we design this open phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as adjuvant chemotherapy for resectable pancreatic cancer in China.

Eligibility

Min Age: 18 YearsMax Age: 79 Years

Inclusion Criteria10

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 Criteria15

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 ℃.

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Interventions

DRUGFolfirinox

Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.