Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes

April 27, 2016 updated by: YueJuan Cheng, Peking Union Medical College Hospital
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Adjuvant Gemcitabine Versus Gemcitabine With TS-1 based Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection: a randomized phase II study.

Study Type

Interventional

Enrollment (Anticipated)

110

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 Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Division of Medical Oncology, Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Bai Chunmei, MD
        • Sub-Investigator:
          • Cheng Yuejuan, MD

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed resected ductal pancreatic adenocarcinoma with R1 resection and/or positive lymph nodes.
  • Subject should start treatment no later than 10 weeks postsurgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • Acceptable hematology parameters:

    • Absolute neutrophil count ≥1500 cell/mm3
    • Platelet count ≥100,000/mm3
    • Hemoglobin (Hgb) ≥8.0 g/dL

  • Acceptable blood chemistry levels:

    • Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤2.5 × upper limit of normal range (ULN)
    • Total bilirubin ≤ 2.5 x upper Limit of Normal (ULN)
    • Serum creatinine within upper limits of normal.
  • Cancer antigen (CA)19-9 ≤ 2.5 x upper Limit of Normal (ULN) assessed within 14 days of randomization.
  • No disease recurrence or metastases detected on CT/MRI assessed within 30 days of randomization.
  • Signed informed consent.

Exclusion Criteria:

  • R2 resection or presence of metastatic disease.
  • Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma.
  • Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
  • Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.

  • Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the 6 months of study registration
    • Uncontrolled hypertension, diabetes or arrhythmia.
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
  • Not able to take medicine orally.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: chemotherapy
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles.
Drug: Gemcitabine
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles
Other Names:
  • chemotherapy
Experimental: chemotherapy with chemoradiation
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation.
Drug: Gemcitabine
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles
Other Names:
  • chemotherapy
Radiation: TS-1 with radiation
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: From date of randomization until the date of first documented disease recurrence or date of death from any cause, whichever came first, assessed up to 24 months
From date of randomization until the date of first documented disease recurrence or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 36 months
From date of randomization until the date of death from any cause, assessed up to 36 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: from randomization to 1 month after end of treatment
from randomization to 1 month after end of treatment

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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

March 1, 2016

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-1015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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