Stage IA Pancreatic Adenocarcinoma Clinical Trial
Official title:
An Exploratory Clinical Trial of Nab-Paclitaxel and Gemcitabine Compared With Gemcitabine and Tegafur in Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer
Treatment, Prospective, Assignment, Open Label, Single-center, Non-randomized Study An exploratory clinical trial of comparison of Nab-Paclitaxel combined with Gemcitabine and Gemcitabine combined with Tegafur for adjuvant chemotherapy after radical resection of pancreatic cancer
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Signed informed content obtained prior to treatment - Age =18 years and = 80 years - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Pathologically confirmed after R0 resection of pancreatic adenocarcinoma. - The expected survival after surgery = 6 months - No serious blood system, heart, lung function abnormalities and immune defects (refer to the respective standards) - White blood cell (WBC) = 3 × 109/L; Absolute neutrophil count (ANC) = 1.5 × 109/L; Platelets (PLT) = 100 × 109/L; Hemoglobin (Hgb)= 9 g/dL - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) = 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) = ULN; Creatinine (CRE) = 1.5 × ULN - Prothrombin time (PT) and international normalized ratio (INR) = 1.5 ×ULN - Baseline (postoperative) abdominal pelvic CT (plain scan + enhancement) and chest CT scan without tumor lesions; - No serious adverse events (fatal or life-threatening, persistent or significant loss of function or disability, requiring hospitalization or prolonged hospital stay) within 4-12 weeks after surgery; - Comply with research visit plans and other program requirements. Exclusion Criteria: - with other systemic malignancies - Patients who have received any form of anti-tumor therapy before surgery, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy - used any other study drug within 5 weeks prior to enrollment; - Patients with central nervous system diseases, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled - Uncontrolled infection, hemorrhage, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination; acute and chronic metabolic acidosis (including ketoacidosis, lactic acidosis) failed to be corrected; - History of allergic reactions attributed to compounds of similar chemical or biological composition to nab-paclitaxel or gemcitabine or tegafur - Pregnant or nursing women - Any condition that may compromise patient safety or study data integrity, including serious medical risk factors, medical conditions, and laboratory abnormalities; - Patients may leave the observation for 7 days or more during the study. |
Country | Name | City | State |
---|---|---|---|
China | Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence free survival (RFS) | To evaluate the therapeutic efficacy of comparison of Nab-Paclitaxel combined with Gemcitabine and Gemcitabine combined with Tegafur chemotherapy in terms of recurrence-free survival in patients with pancreatic cancer after curative resection. Computed tomography (CT) scan | From date of the first day after surgery until the date of the recurrence of the disease (local recurrence and/or distant metastasis) or death from any cause,whichever came first, assessed up to 20 months | |
Secondary | Overall survival (OS) | To evaluate the overall survival of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview | From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter | |
Secondary | Quality of life (Qol) | To evaluate the quality of life score of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview | One month during therapy and 3 months thereafter | |
Secondary | Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0 | To evaluate the occurrence of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; version 4.0) in patients treated with this regimen. The toxicity profile includes but not limits neutropenia, thrombocytopenia, peripheral neuropathy, hypoglycemia, metabolic acidosis (acute or chronic, including ketoacidosis), which will be summarized as the percentage of patients by type and grade according to treatment group. Outpatient visit, laboratory findings | One week during therapy and 3 months thereafter | |
Secondary | CA199 level after curative resection | To evaluate the CA199 level of patients (after curative resection) treated with this regimen. Outpatient visit, laboratory findings | One month during therapy and 3 months thereafter |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02023021 -
Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection
|
Phase 2 | |
Completed |
NCT02005419 -
Metformin Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection
|
Phase 2 |