Unique ID issued by UMIN | UMIN000005559 |
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Receipt number | R000005932 |
Scientific Title | Preoperative chemotherapy with gemcitabine and S-1, evaluation of safety and efficiency |
Date of disclosure of the study information | 2011/05/09 |
Last modified on | 2016/01/07 09:44:28 |
Preoperative chemotherapy with gemcitabine and S-1, evaluation of safety and efficiency
Preoperative chemotherapy with gemcitabine and S-1, evaluation of safety and efficiency
Preoperative chemotherapy with gemcitabine and S-1, evaluation of safety and efficiency
Preoperative chemotherapy with gemcitabine and S-1, evaluation of safety and efficiency
Japan |
gallbladder cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
evaluation of safety and efficiency of preoperative chemotherapy with gemcitabine and tegafur/gimeracil/oteracil potassium for clinically stage 3 or 4 gallbladder cancer patient
Safety
Exploratory
Pragmatic
Phase I,II
Pathological curative resection rate
Disease control rate (DCR)
Progression free survival (PFS)
Time to progression (TTP)
Overall survival (OS)
Median survival time (MST)
adverse events rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
administration of gemcitabine (1000mg/m2, div, over 30min, day1, 8), oral administration of tegafur/gimeracil/oteracil potassium (60-100mg/body, day1-14) and wash out period (day15-21), define as 1 cycle (21 days). After 2 cycles, opereation is performed. Evaluation of adverse effect grade with NCI-CTC ver.4 and of tumor progression (RECIST ver. 3.1).
20 | years-old | <= |
75 | years-old | > |
Male and Female
(1) Diagnosed as gallbladder cancer
(2) clinically stage 3, 4a, 4b in General Rules for Surgical and Pathological Studies on Cancer of the Biliary Tract (Japanese Society of Biliary Surgery, The 5th edition)
(3) possibly resectable at diagnostic time
(4) no previous chemotherapy for gallbladder cancer
(5) no previous radiation therapy for gallbladder cancer
(6) ECOG performance status (PS) is 0 or 1
(7) aged over 20 and less than 75
(8) Life expectancy > 3 months
(9) Sufficient oral intake
(10) good general condition
(11) written informed consent
(12) patient with judgement
(1) with severe infection
(2) with fever >38 degrees C
(3) Serious complications (e.g. severe heart desease, plumonary fibrosis, interstitial pneumonia)
(4) past history of plumonary fibrosis, interstitial pneumonia or renal failure with dialysis)
(5) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy
(6) with brain metastasis
(7) with pericardial fluid
(8)Pregnant or lactating women or women of childbearing potential (restrict lactating within 8 weeks after last Panitmumab administration)
(9)Patient with severe drug allergy
(10)Psychosis or severe mental disorder
(11)Inadequate physical condition, as diagnosed by primary physician
20
1st name | |
Middle name | |
Last name | Hiroki Hayashi |
Tohoku University Hospital
Hepato-Biliary Pancreatic Surgery
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
022-717-7205
hiorki@surg1.med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Hiroki Hayashi |
Tohoku University Hospital
Hepato-Biliary Pancreatic Surgery
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
022-717-7205
hiroki@surg1.med.tohoku.ac.jp
Division of Hepato-Biliary Pancreatic Surgery
, Tohoku University Hospital
none
Self funding
NO
東北大学病院(宮城県)
2011 | Year | 05 | Month | 09 | Day |
Unpublished
Open public recruiting
2011 | Year | 03 | Month | 31 | Day |
2011 | Year | 04 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2016 | Year | 05 | Month | 01 | Day |
2011 | Year | 05 | Month | 06 | Day |
2016 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005932
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