Unique ID issued by UMIN | UMIN000003658 |
---|---|
Receipt number | R000004429 |
Scientific Title | Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer (YCOG001) |
Date of disclosure of the study information | 2010/05/24 |
Last modified on | 2015/01/18 03:25:55 |
Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer (YCOG001)
Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer (YCOG001)
Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer (YCOG001)
Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer (YCOG001)
Japan |
Pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
to evaluate the efficacy and safety of gemcitabine with an EPA riched oral supliment compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.
Safety,Efficacy
Exploratory
Phase II
overall survival (1-year survival)
progression-free survival, response rate, adverse events, severe, QOL evaluation, body weight, performance status.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Food |
Gemcitabine 1000mg/m2 was administered in a 30min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until disease progression. In addition, an EPA-enriched oral supplement was taken every day as the maximum of 2 packs.
Gemcitabine 1000mg/m2 was administered in a 30min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until disease progression.
20 | years-old | <= |
Not applicable |
Male and Female
1. Diagnosed as pancreatic cancer
2. Recurrent or unresectable pancreatic cancer
3. Histologically proven invasive tubular adenocarcinoma, or adenosquamous carcinoma for pancreatic cancer
4. Without CNS metastasis
5. ECOG PS of 0, 1 or 2
6. Sufficient oral intake
7. Aged over 20 years old
8. Adequate organ functions
9. Written informed consent
1. With moderate or more ascites/pleural effusion
2. Plumonary fibrosis or interstitial pneumonia
3. Cardiac insufficiency or myocardial infarction within six months
4. Active bacterial or fungous infection
5. Uncontrollable diabetes mellitus
6. Psychosis or severe mental disorder
7. Severe drug allergy
8. Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy
9. Previous chemotherapy or radiotherapy against any other malignancies within 3 years
10. Gemcitabine chemotherapy but with the permission over 6 months after adjuvant chemotherapy
11. Previous therapy against pancreatic cancer
12. With CNS metastasis
13. Pregnant, lactating women or women of childbearing potential
14. Men who want to get partner pregnant
15. Inadequate physical condition, as diagnosed by primary physician
66
1st name | |
Middle name | |
Last name | Shinichi Ohkawa |
Kanagawa Cancer Center
Division of Hepatobiliary and Pancreatic Medical Oncology
1-1-2 Nakao Asahi-ku Yokohama City
045-520-2222
uenom@kcch.jp
1st name | |
Middle name | |
Last name | Makoto Ueno |
YCOG001 Coordinating Office
Division of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center
1-1-2 Nakao Asahi-ku Yokohama City
045-391-5761
kantansui@kcch.jp
kanagawa cancer center
none
Self funding
NO
神奈川県立がんセンター
2010 | Year | 05 | Month | 24 | Day |
Unpublished
Main results already published
2010 | Year | 05 | Month | 21 | Day |
2010 | Year | 05 | Month | 01 | Day |
2013 | Year | 05 | Month | 01 | Day |
2010 | Year | 05 | Month | 24 | Day |
2015 | Year | 01 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004429