Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

Study Overview
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Brief Summary
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A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer

Detailed Description
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A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.

Official Title
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Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

Conditions
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Pancreatic Cancer, Nab-paclitaxel, Gemcitabine, S1

Intervention / Treatment
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* Drug: S1 or Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological confirmation of pancreatic adenocarcinoma Distant metastatic or unresctable locally advanced diseases CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment At least one lesion measurable by RECIST v1.1 criteria Life expectancy> 3 months No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion) No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone) Pain must be monitored before inclusion 18 years < age < 70 Performance status: 0-1 ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable), creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min Patient information and signature of informed consent Exclusion Criteria: Concurrent other effective treatment (including radiotherapy) Resectable patients Allergy history to other drugs in the same class patients with pregnancy or lactation Known severe internal medical diseases Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia Immunocompromised patients, such as HIV positive Uncontrollable mental illness Other conditions the researchers considered ineligible for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S/nab<br>Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w) | Drug: S1 or Gemcitabine<br>* Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)<br>|
| Active Comparator: Gem/nab<br>Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w) | Drug: S1 or Gemcitabine<br>* Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival | 1 year | 
| ORR | objective response rate | 6 month | 
| DCR | CR+PR+SD was defined as disease control rate (DCR) | 6 month | 
| Safety profile :Adverse events of nab-Paclitaxel plus S-1 | Adverse events of nab-Paclitaxel plus S-1 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, nab-paclitaxel, gemcitabine, S1