Chemotherapy Effect, Pancreatic Adenocarcinoma
Conditions
Keywords
pancreatic cancer, second line chemotherapy, nab-paclitaxel
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.
Interventions
DRUGChemotherapy (Gemcitabine + nab-paclitaxel)
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
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Inclusion criteria 1. Patient whose age is 20 years or older 2. ECOG Performance Status 0-2 3. Pathologically confirmed pancreatic adenocarcinoma 4. Patients with locally advanced or distant metastasis status 5. Patients who had undergone primary chemotherapy with previous FOLFIRINOX and whose disease progress was confirmed 6. Patients whose consent was obtained (non-insurance agreement) 2.
Exclusion criteria
1. Those who can not obtain consent 2. Those who refuse chemotherapy 3. ECOG Performance Status 3 or higher 4. Multiple organ failure is accompanied 5. Severe comorbidities other than cancer that do not expect a sufficient survival period over 1 month 6. Allergy to the test drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| survival rate | 6 months | survival rate at 6 months after 2nd line chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | till death or follow-up loss or end of study up to 2 years | overall survival 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 |
| 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 |
Countries
South Korea
Contacts
Primary ContactJin Ho Choi, MD
Backup ContactSang Hyub Lee, MD, Ph.D
Outcome results
None listed