The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer
- Conditions
- Pancreatic AdenocarcinomaChemotherapy Effect
- Interventions
- Drug: Chemotherapy (Gemcitabine + nab-paclitaxel)
- Registration Number
- NCT03401827
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine + nab-paclitaxel Chemotherapy (Gemcitabine + nab-paclitaxel) Case with chemotherapy (Gemcitabine + nab-paclitaxel)
- Primary Outcome Measures
Name Time Method survival rate 6 months survival rate at 6 months after 2nd line chemotherapy
- Secondary Outcome Measures
Name Time Method overall survival till death or follow-up loss or end of study up to 2 years overall survival after 2nd line chemotherapy
Disease control rate 6 months SD (stable disease) + PR (partial response) + CR (complete response) after 2nd line chemotherapy
adverse event till death or follow-up loss or end of study up to 2 years all reported adverse events after 2nd line chemotherapy
Progression free survival till death or follow-up loss or end of study up to 2 years duration till progression after 2nd line chemotherapy
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of