The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer refractory to chemotherapy.
Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity. Carbohydrate antigen 19-9 (CA19-9) is the most widely used biomarker in pancreatic cancer. Circulating CA19-9 levels are positively correlated with tumor burden and stage in pancreatic cancer with a diagnostic sensitivity of approximately 80%, suggesting that approximately 20% of patients have normal CA19-9 levels. It is well recognized that Lewis (-) individuals, constituting approximately 10% of the population, have low or no secretion of CA19-9 due to the lack of critical enzyme involved in CA19-9 biosynthesis. Thus, approximately 10% of patients with pancreatic cancer have normal CA19-9 levels regardless of tumor stage. Our previously retrospective study has shown that CA19-9-normal advanced pancreatic cancer may be more sensitive to chemotherapy combined with radiotherapy. The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to patients with CA19-9-normal advanced pancreatic cancer who are refractory to chemotherapy. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every four weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Chemotherapy will be administered according to the newest edition of National Comprehensive Cancer Network (NCCN) guideline and a modified FOLFIRINOX regimen will be the first choice. Patients with advanced pancreatic adenocarcinoma will receive the modified FOLFIRINOX regimen (oxaliplatin \[70 mg per square meter of body surface area\], irinotecan \[130 mg per square meter\], leucovorin \[200 mg per square meter\], and fluorouracil \[2000 mg per square meter\] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2\~6 cycles of chemotherapy. The following treatment after radiotherapy will be applied according to the newest edition of NCCN guideline.
Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGprogression-free survival, PFS
PFS of subjects from recruiting to the time of disease progression
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall survival，OS
OS of subjects from recruiting to the time of death from any cause
Time frame: At the end of Cycle 1 (each cycle is 28 days)
objective response rate (ORR)
CR + PR
Time frame: At the end of Cycle 1 (each cycle is 28 days)
disease control rate (DCR)
CR + PR + SD
Time frame: At the end of Cycle 1 (each cycle is 28 days)
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