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

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

Detailed Description
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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.

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

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Drug: Gemcitabine
* Radiation: TS-1 with radiation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: chemotherapy<br>gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. | Drug: Gemcitabine<br>* gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles<br>* Other names: chemotherapy;|
| Experimental: chemotherapy with chemoradiation<br>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<br>* gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles<br>* Other names: chemotherapy;Radiation: TS-1 with radiation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adjuvant, pancreatic cancer, R1 resection, positive lymph nodes