Back to resultsNab-P and Gem Compared With Gem and Tegafur in Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer
Primary Purpose
Stage IA Pancreatic Adenocarcinoma, Stage IB Pancreatic Adenocarcinoma, Stage IIA Pancreatic Adenocarcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nab-paclitaxel
Gemcitabine
tegafur
Sponsored by
About this trial
This is an interventional treatment trial for Stage IA Pancreatic Adenocarcinoma
Eligibility Criteria
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.
Sites / Locations
- Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, ChinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
nab-paclitaxel + gemcitabine
tegafur + gemcitabine
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Overall survival (OS)
To evaluate the overall survival of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview
Quality of life (Qol)
To evaluate the quality of life score of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview
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
CA199 level after curative resection
To evaluate the CA199 level of patients (after curative resection) treated with this regimen. Outpatient visit, laboratory findings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04216758
Brief Title
Nab-P and Gem Compared With Gem and Tegafur in Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IA Pancreatic Adenocarcinoma, Stage IB Pancreatic Adenocarcinoma, Stage IIA Pancreatic Adenocarcinoma, Stage IIB Pancreatic Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nab-paclitaxel + gemcitabine
Arm Type
Experimental
Arm Description
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
Arm Title
tegafur + gemcitabine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
tegafur
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence free survival (RFS)
Description
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
Time Frame
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 Outcome Measure Information:
Title
Overall survival (OS)
Description
To evaluate the overall survival of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview
Time Frame
From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter
Title
Quality of life (Qol)
Description
To evaluate the quality of life score of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview
Time Frame
One month during therapy and 3 months thereafter
Title
Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0
Description
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
Time Frame
One week during therapy and 3 months thereafter
Title
CA199 level after curative resection
Description
To evaluate the CA199 level of patients (after curative resection) treated with this regimen. Outpatient visit, laboratory findings
Time Frame
One month during therapy and 3 months thereafter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xian-jun Yu, M.D Ph.D
Phone
+86-21-64175590
Email
wangwenquan@fudanpci.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian-Jun Yu, M.D Ph.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xian-Jun Yu, M.D., Ph.D.
Phone
+86-21-64175590
Email
yuxianjun88@hotmail.com
First Name & Middle Initial & Last Name & Degree
Wen-quan Wang, M.D., Ph.D.
Phone
+86-21-64175590
Email
wangwenquan@fudanpci.org
First Name & Middle Initial & Last Name & Degree
Xian-Jun Yu, M.D., Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nab-P and Gem Compared With Gem and Tegafur in Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer
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