Unique ID issued by UMIN | UMIN000020366 |
---|---|
Receipt number | R000023523 |
Scientific Title | Considerations of recurrence prevention efficacy of gemcitabine for patients with resected pancreatic cancer |
Date of disclosure of the study information | 2015/12/27 |
Last modified on | 2015/12/29 16:43:50 |
Considerations of recurrence prevention efficacy of gemcitabine for patients with resected pancreatic cancer
Considerations of recurrence prevention efficacy of gemcitabine for patients with resected pancreatic cancer
Considerations of recurrence prevention efficacy of gemcitabine for patients with resected pancreatic cancer
Considerations of recurrence prevention efficacy of gemcitabine for patients with resected pancreatic cancer
Japan |
resected pancreatic cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
The aim of this study is to evaluate the efficacy of recurrence prevention using gemcitabine for patients with resected pancreatic cancer.
Others
Outside comparative study to 'The development of a novel dual-targeting peptide vaccine therapy in patients with resected pancreatic cancer' UMIN000007991
disease-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days,1,8 and 15 for 24 weeks.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
(1) Invasive pancreatic ductal carcinoma histologically confirmed as papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma or adenosquamous carcinoma of the pancreas.
(2) Histologically confirmed R0 or R1 resected invasive pancreatic ductal carcinoma.
(3) No recurrence
(4) No Prior treatment for pancreatic cancer except surgical resection.
(5) Patients must be >=20 years old and <=80 years old at the time of consent.
(6) ECOG Performance Status must be 0 or 1.
(7) The following criteria must be satisfied in laboratory tests.
1) White blood cell count >=3,500/mm3
2) Neutrophil count >=2,000/mm3
3) Hemoglobin >= 9.0 g/dL
4) Platelet count >=100,000mm3
5) Total bilirubin <=2.0 mg/dL
6) AST <=150 IU/L
7) ALT <=150 IU/L
8) Serum Creatinine <=1.5 mg/dL
(8) No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment.
(9) Patients must be enrolled more than 2 weeks elapsed from resection of pancreatic cancer, not to exceed 10 weeks.
(10) Patients must have signed the consent form.
(1) Interstitial pneumonia or pulmonary fibrosis.
(2) Patients who require systemic administration of the following agents during the study treatment period.
1.Corticosteroid
2.Immunosuppresant, Immunostimulant
(3) Active infections.
(4) Severe complication (heart failure, renal failure, liver failure, bleeding from digestive ulcer, ileus,and uncontrolled diabetes)
(5) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage.
(6) Active double cancer (include asynchronous double cancer with disease-free duration <=3 year) except carcinoma in situ or intramucosal cancer.
(7) Prior treatment of peptide derived from KIF20A, VEGFR-1and VEGFR-2.
(8) Prior cancer treatment except for pancreatic cancer (chemotherapy, hormone therapy, antibody therapy, radiation therapy, immunotherapy, and hyperthermia).
(9) Severe mental disorder.
(10) Sever drug-induced hypersensitivity
(11) Unhealed traumatic lesion, including traumatic fracture.
(12) History of myocardial infarction, severe unstable angina pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months before administration of OCV-C01.
(13) Need continuous medication of antiplatelet drug except aspirin.
(14) Uncontrolled hypertension.
(15) Heart failure and arrhythmia that needs treatment.
(16) Aneurysms and varices with serious concern of bleeding.
(17) Current participation in other clinical trials.
(18) Patients or partners, who don't attempt to doing contraception during the study period (during the study period and until 180 days after the last administration day for male, or until 120 days after the last administration day for female.).
(19) Pregnant females or nursing mothers who can not stop lactation during the recruitment until 120 days after the last administration.
(20) The subject who was determined by investigator that being not adequate to participate in the trial.
30
1st name | |
Middle name | |
Last name | Hiroki Yamaue |
Wakayama Medical University
Second Department of Surgery
811-1 Kimiidera Wakayama
073-441-0613
yamaue-h@wakayama-med.ac.jp
1st name | |
Middle name | |
Last name | Motoki Miyazawa |
Wakayama Medical University
Second Department of Surgery
811-1 Kimiidera Wakayama
073-441-0613
mo-0702@wakayama-med.ac.jp
Second Department of Surgery, Wakayama Medical University
Ministry of Health, Labour and Welfare
NO
2015 | Year | 12 | Month | 27 | Day |
Unpublished
Completed
2012 | Year | 04 | Month | 01 | Day |
2012 | Year | 07 | Month | 01 | Day |
2014 | Year | 09 | Month | 30 | Day |
2015 | Year | 12 | Month | 27 | Day |
2015 | Year | 12 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023523