Neoplasms

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Pancreatic Neoplasms

Adenocarcinoma

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

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Gastrointestinal Diseases

Pancreatic Diseases

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Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Hypoglycemic Agents

Gemcitabine

Metformin

Antimetabolites

gemcitabine at 1000 mg/m\^2 on days 1, 8, and 15; placebo at 2 g on days 1-28

gemcitabine at 1000 mg/m\^2 on days 1, 8, and 15; metformin at 2 g on days 1-28

Patients receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment, and also receive placebo (Arm I)/ metformin (Arm II) on days 1-28. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Metformin will be administered at a dose of 500 mg twice daily. If well tolerated, the dose will be increased to 1000 mg twice daily in the second week. Treatment repeats every 4 weeks (2 g on days 1-28) for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Placebo will be administered at a dose of 500 mg twice daily. If well tolerated, the dose will be increased to 1000 mg twice daily in the second week. Treatment repeats every 4 weeks (2 g on days 1-28) for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

placebo

Xianjun Yu, M.D., Ph.D.

Pancreatic cancer represents the most lethal of the common malignancies with a 5-year survival rate of less than 5%. For patients who are eligible for potentially curative resection, despite mortality and morbidity rates after surgery have improved, the recurrence rate is up to 85% within 2 years. Data from clinical trials indicate that adjuvant chemotherapy enhances 5-year survival to \~25% for patients who have undergone surgery to remove their tumor; and gemcitabine is the standard regimen of chemotherapy. Metformin is the first-line treatment for type 2 diabetes mellitus. Literatures reported that metformin might inhibit tumor growth by blocking some enzymes needed for cell growth. Some retrospective studies have revealed that diabetic patients taking metformin were less likely to develop pancreatic cancer. Additionally, pancreatic cancer patients treated with metformin showed a better survival than those without metformin. In this study, the researchers intend to investigate the activity and safety of the combination of gemcitabine and metformin in treating patients with pancreatic cancer that have removed by surgery.

Metformin Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection

A Phase II, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of the Combination of Gemcitabine and Metformin in Treating Patients With Pancreatic Cancer After Curative Resection

To evaluate the therapeutic efficacy of gemcitabine chemotherapy with versus without metformin hydrochloride in terms of recurrence-free survival in patients with pancreatic cancer at one year after curative resection. Computed tomography (CT) scan

To evaluate the overall survival of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview

To evaluate the quality of life score of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview

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

Xian-Jun Yu

M.D., Ph.D.

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

nab-paclitaxel at 100 mg/m\^2 on days 1, 8, and 15; gemcitabine at 1000 mg/m\^2 on days 1, 8, and 15

Patients firstly receive nab-paclitaxel 100 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

nab-paclitaxel

Patients secondly receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

gemcitabine

Xian-Jun Yu, M.D., Ph.D.

Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than 5%. About 25% of patients have the opportunity for radically surgical resection when diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and enhanced overall survival for patients who have undergone surgery to remove their tumor. Nab-paclitaxel could enhance the intratumoral concentration of gemcitabine; recent studies showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival and overall survival of metastatic pancreatic cancer patients. The present study is intended to investigate the activity and safety of the combination of gemcitabine and nab-paclitaxel as adjuvant chemotherapy in treating patients with pancreatic cancer after curative resection.

Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection

A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Pancreatic Cancer After Curative Resection

To evaluate the therapeutic efficacy of nab-paclitaxel plus gemcitabine chemotherapy in terms of recurrence-free survival in patients with pancreatic cancer at one year after curative resection. Computed tomography (CT) scan

To evaluate the CA199 level of patients (after curative resection) treated with this regimen. Outpatient visit, laboratory findings

Tegafur

gemcitabine at 1000 mg/m\^2 on days 1, 8, and 15; tegafur: Body surface area \< 1.25 m\^2, 60 mg/d; Body surface area ≥ 1.25 m\^2 to \< 1.5 m\^2, 80 mg/d; Body surface area ≥ 1.5 m\^2, 100 mg/d; Oral (po), Bid, D1-21

Patients receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Patients secondly receive tegafur Body surface area \< 1.25 m\^2, 60 mg/d;Body surface area ≥ 1.25 m\^2 to \< 1.5 m\^2, 80 mg/d;Body surface area ≥ 1.5 m\^2, 100 mg/d (po) on days 1-21 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

tegafur

Xian-jun Yu, M.D Ph.D

Wen-quan Wang, M.D., Ph.D.

Xian-Jun Yu, M.D Ph.D

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

Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than 5%. About 25% of patients have the opportunity for radically surgical resection when diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and enhanced overall survival for patients who have undergone surgery to remove their tumor. Nab-paclitaxel could significantly increase the concentration of gemcitabine in the tumor; recent studies showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival and overall survival of metastatic pancreatic cancer patients. A study in Japan and Taiwan compared the efficacy of gemcitabine in combination with tegafur in patients with locally advanced or metastatic pancreatic cancer. The median progression-free survival was significantly better in the gemcitabine combined with the tegafur group than in the gemcitabine group. The present study is intended to observe the effect of albumin paclitaxel combined with gemcitabine and tegafur combined with gemcitabine on recurrence-free survival in patients with pancreatic adenocarcinoma undergoing radical resection.

Nab-P and Gem Compared With Gem and Tegafur in Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer

An Exploratory Clinical Trial of Nab-Paclitaxel and Gemcitabine Compared With Gemcitabine and Tegafur in Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metformin Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection	NCT02005419	Stage IA Pancre... Stage IB Pancre... Stage IIA Pancr... Stage IIB Pancr...	Gemcitabine Metformin placebo	18 Years - 80 Years	Fudan University
Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection	NCT02023021	Stage IA Pancre... Stage IB Pancre... Stage IIA Pancr... Stage IIB Pancr...	nab-paclitaxel gemcitabine	18 Years - 75 Years	Fudan University
Metformin Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection	NCT02005419	Stage IA Pancre... Stage IB Pancre... Stage IIA Pancr... Stage IIB Pancr...	Gemcitabine Metformin placebo	18 Years - 80 Years	Fudan University
Nab-P and Gem Compared With Gem and Tegafur in Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer	NCT04216758	Stage IA Pancre... Stage IB Pancre... Stage IIA Pancr... Stage IIB Pancr...	nab-paclitaxel Gemcitabine tegafur	18 Years - 80 Years	Fudan University

Spots Global Cancer Trial Database for stage ib pancreatic adenocarcinoma