Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, adjuvant chemotherapy, FOLFIRINOX
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 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
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.
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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 ℃.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | up to 24 months | From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | up to 24 months | From the date of first drug administration until the date of death |
Countries
China
Contacts
Primary ContactMiaozhen Qiu
Outcome results
None listed