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

June 27, 2020 updated by: Xian-Jun Yu, Fudan University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: nab-paclitaxel + gemcitabine
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
Drug: nab-paclitaxel
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.
Other Names:
  • Abraxane
Drug: Gemcitabine
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.
Other Names:
  • Gemzar
EXPERIMENTAL: tegafur + gemcitabine
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
Drug: Gemcitabine
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.
Other Names:
  • Gemzar
Drug: tegafur
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival (RFS)
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
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
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
Quality of life (Qol)
Time Frame: One month during therapy and 3 months thereafter
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
Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0
Time Frame: One week during therapy and 3 months thereafter
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
CA199 level after curative resection
Time Frame: One month during therapy and 3 months thereafter
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xian-Jun Yu, M.D Ph.D, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

July 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

December 31, 2019

First Submitted That Met QC Criteria

January 1, 2020

First Posted (ACTUAL)

January 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 27, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPAC-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stage IA Pancreatic Adenocarcinoma

Clinical Trials on nab-paclitaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe