mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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 endpoints are overall survival, safety and quality of life.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Folfirinox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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 ℃.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLFIRINOX<br>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. | Drug: Folfirinox<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | From the date of first drug administration until the date of death | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, adjuvant chemotherapy, FOLFIRINOX