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

Primary Purpose

Pancreatic Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gemcitabine
TS-1 with radiation
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring adjuvant, pancreatic cancer, R1 resection, positive lymph nodes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Division of Medical Oncology, Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

chemotherapy

chemotherapy with chemoradiation

Arm Description

gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles.

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.

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

overall survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Full Information

First Posted
April 20, 2016
Last Updated
April 27, 2016
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02754180
Brief Title
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes
Official Title
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
Keywords
adjuvant, pancreatic cancer, R1 resection, positive lymph nodes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles.
Arm Title
chemotherapy with chemoradiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
chemotherapy
Intervention Description
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles
Intervention Type
Radiation
Intervention Name(s)
TS-1 with radiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
From date of randomization until the date of death from any cause, assessed up to 36 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bai Chunmei, MD
Phone
861069158773
Email
baichunmei1964@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Yuejuan, MD
Phone
861069158773
Email
cnchengyuejuan@yahoo.com
Facility Information:
Facility Name
Division of Medical Oncology, Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuejuan Cheng, M.D.
Phone
861069158315
Email
cnchengyuejuan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Bai Chunmei, MD
First Name & Middle Initial & Last Name & Degree
Cheng Yuejuan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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