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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03401827
Other study ID # H-1710-067-894
Secondary ID
Status Recruiting
Phase Phase 4
First received December 30, 2017
Last updated February 8, 2018
Start date March 1, 2018
Est. completion date January 1, 2019

Study information

Verified date January 2018
Source Seoul National University Hospital
Contact Jin Ho Choi, MD
Phone 82-2-2072-2228
Email pseudo.jh@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 40
Est. completion date January 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Chemotherapy (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

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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