The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
Pancreatic cancer is a very poor prognosis and has a high mortality rate. The clinical results have improved somewhat with the combination therapy of chemotherapy as the first-line treatment. However, effective secondary chemotherapy after these first-line treatment failures is limited. Recently, FOLFIRINOX has been used in patients with locally advanced or metastatic pancreatic cancer who have good performance in Korea. Gemcitabine + nab-paclitaxel (GnP) as a second-line treatment after FOLFIRINOX may be expected to be considerable. The aim of this study was to evaluate the efficacy of GnP as a second-line treatment after failed FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.

Detailed Description
-----------------
Pancreatic cancer is a very poor prognosis and has a high mortality rate. It is not clear that the improvement of clinical outcome due to anticancer drugs is not clear compared to other carcinomas. In particular, the 5-year survival rate of metastatic pancreatic cancer is still only about 2%, and the clinical results have improved somewhat with the combination therapy of chemotherapy as the first-line treatment. However, effective secondary chemotherapy after these first-line treatment failures is limited. Meta-analysis has reported that life expectancy is significantly increased in patients receiving second-line chemotherapy after failure of primary chemotherapy. However, it is not yet clear which cancer treatment is most effective. In the NCCN guideline (ver. 2017.2), the second trial of chemotherapy for locally advanced or metastatic pancreatic cancer is the most recommended clinical trial.Recently, FOLFIRINOX has been used in patients with locally advanced or metastatic pancreatic cancer who have good performance in Korea. The response rate of the treatment is 30%, and many patients require secondary chemotherapy. In a practice guideline published by the American Society of Clinical Oncology, Gemcitabine + nab-paclitaxel(GnP) is the only recommended combination for patients failing primary treatment with FOLFIRINOX. In light of the results of previous reports, the efficacy of GnP as a second-line treatment after FOLFIRINOX may be expected to be considerable, but there is a lack of studies reporting GnP therapy on the second line after FOLFIRINOX failure as a first-line treatment. The aim of this study was to evaluate the efficacy of GnP as a second-line treatment after failed FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.

Official Title
-----------------
The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer

Conditions
-----------------
Pancreatic Adenocarcinoma, Chemotherapy Effect

Intervention / Treatment
-----------------
* Drug: Chemotherapy (Gemcitabine + nab-paclitaxel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patient whose age is 20 years or older ECOG Performance Status 0-2 Pathologically confirmed pancreatic adenocarcinoma Patients with locally advanced or distant metastasis status Patients who had undergone primary chemotherapy with previous FOLFIRINOX and whose disease progress was confirmed Patients whose consent was obtained (non-insurance agreement) Exclusion Criteria Those who can not obtain consent Those who refuse chemotherapy ECOG Performance Status 3 or higher Multiple organ failure is accompanied Severe comorbidities other than cancer that do not expect a sufficient survival period over 1 month Allergy to the test drug

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine + nab-paclitaxel<br>Case with chemotherapy (Gemcitabine + nab-paclitaxel) | Drug: Chemotherapy (Gemcitabine + nab-paclitaxel)<br>* Nanoparticle albumin-bound paclitaxel (125 mg/m2) miv over 30 min, Day 1,8,15 Gemcitabine (1,000mg/m2) and N/S 150mL miv over 30 min, Day 1,8,15<br>* Other names: GnP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate | survival rate at 6 months after 2nd line chemotherapy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall survival after 2nd line chemotherapy | till death or follow-up loss or end of study up to 2 years | 
| Progression free survival | duration till progression after 2nd line chemotherapy | till death or follow-up loss or end of study up to 2 years | 
| Disease control rate | SD (stable disease) + PR (partial response) + CR (complete response) after 2nd line chemotherapy | 6 months | 
| adverse event | all reported adverse events after 2nd line chemotherapy | till death or follow-up loss or end of study up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, second line chemotherapy, nab-paclitaxel