Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation In Pancreatic Adenocarcinoma With R1 Resection And/or Positive Lymph Nodes

Study Overview

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

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

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.

Pancreatic Neoplasms

DRUG: Gemcitabine
RADIATION: TS-1 with radiation

ZS-1015

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-04-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-04-27
First Submitted that Met QC Criteria 2016-04-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-04-28
First Posted (ESTIMATED) 2016-04-28	Results First Posted N/A	Last Verified 2016-04

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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 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.
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 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.

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

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.

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

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.

Primary Outcome Measures	Measure Description	Time Frame
Disease free survival		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	Measure Description	Time Frame
overall survival		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		from randomization to 1 month after end of treatment

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

Name: Bai Chunmei, MD

Phone Number: 861069158773

Email: baichunmei1964@163.com

Study Contact Backup

Name: Cheng Yuejuan, MD

Phone Number: 861069158773

Email: cnchengyuejuan@yahoo.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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.

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.

Collaborators and Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record