Unique ID issued by UMIN | UMIN000005708 |
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Receipt number | R000006750 |
Scientific Title | Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer. |
Date of disclosure of the study information | 2011/06/02 |
Last modified on | 2015/04/21 08:34:42 |
Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
(KOGC-05 Trial)
Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
(KOGC-05 Trial)
Japan |
Patients with unresctable or recurrent gastric cancer.
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Adult |
Malignancy
NO
To assess maximum tolerated dose in order to determine recommended dose of capecitabine plus fractional cisplatin as the first-line therapy in patients with resectable or recurrent gastric cancer.
Furthermore, this exploratory study is also designed to evaluate predictable several factor levels in the resected tumor tissues and plasma from the registrated patients.
Safety,Efficacy
Exploratory
Pragmatic
Phase I
Incidence of dose limiting toxicity
Overall Response rate
Exploring several predictable biomarkers
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Capecitabine plus fractional cisplatin:
Level 1
Capecitabine:2,000mg/m2/day p.o.(day1-15)
Cisplatin:15mg/m2 i.v.
(day1, 8, 15)
to be repeated every 3 weeks.
Cisplatin is administered with an initial dose of 15mg/m2, stepped up to 20mg/m2 or 25mg/m2.
20 | years-old | <= |
74 | years-old | >= |
Male and Female
(1) Histological confirmation of gastric adenocarcinoma.
(2) Patients with an advanced or recurrent gastric cancer with estimative lesion, and had received no previous chemotherapy.
i) Patients with unresectable gastric cancer who had not received any intervention except surgical procedure.
ii) Patients with recurrent gastric cancer who had not been treated by any therapy against for the recurrent site.
(3) Patient who are possible to be orally administrated capecitabene.
(4) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 - 1.
(5) 20 years old or more,and 74 years old or less when received informed consent.
(6) Written informed consent.
(7) Life expectancy estimate 3 months, and more.
(8) Vital organ functions (listed below) are preserved within 14 days prior to entry.
i) White blood cell count >= 4,000/mm3
Neutrophils>=2,000/mm3
ii) Platelets>=100,000/mm3
iii).Hemoglobin>=9.0 g/dl
iv).Total bilirubin<=1.5 mg/dl
v). AST and ALT <= 100 I/U
vi). Serum albumin >= 2.5 g/dl
vii). Serum creatinine <= 1.2 mg/dl
or estimated creatinine clearance rate ( Cockcroft-Gault formula) >= 60 mL/min
(1) Patients who had previously received chemotherapy including a fluorouracil-based regimen at least 6 month before registration.
(2) Patients who had previously received chemotherapy including a Platinum-based regimen.
(3) Patients with history of severe adverse event suspected to be caused by dihydropyrimidine dehydrogenase (DPD) deficiency.
(4) Patients who have history of active simultaneous or metachronous double cancers within 5 year.
However, patient with carcinoma in situ or intramucosal carcinoma curable with local therapy is excluded for active double cancer.
(5) Patients With severe or uncontrolled complication (infection, pulmonary fibrosis, intestinal paralysis, intestinal obstruction, uncontrolled diabetes mellitus, liver cirrhosis, history of myocardial infarction within 6 month, unstable angina, and so on.)
(6) Patients with pericardial fluid or massive pleural or peritoneal fluid that required drainage.
(7) Patients with CNS metastases only.
(8) Patients with gastrointestinal bleeding which require a repeat blood transfusion.
(9) Patient who have been treated with antipsychotic drugs, or patient with mental disorder requiring medication.
(10) Patient with recurrent gastric cancer have had history of severe diarrhea (>=Grade 3) in previous adjuvant chemotherapy.
(11) Patients with diarrhea (increase of 4 and more stool frequency per day over baseline or watery stool ) at registration.
(12) Patients who have been treated with antithrombotic drug or drugs affected to coagulation and fibrinolytic system within 2 weeks before registration by the physician decision (Except for low-dose of aspirin).
(13) Patients who are pregnant women, possibly pregnant women, willing to become pregnant, and nursing mothers.
(14) Patients who have condition corresponding with contraindication for the administration of Capecitabine and Cisplatin.
(15) Patients who are inappropriate for the study at the physician's assessment
18
1st name | |
Middle name | |
Last name | Yuko Kitagawa |
School of Medicine, Keio University
Department of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
03-3353-2681
1st name | |
Middle name | |
Last name | Tsunehiro Takahashi |
School of Medicine, Keio University
Department of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
03-3353-2681
Department of Surgery, School of Medicine, Keio University
None
Self funding
NO
2011 | Year | 06 | Month | 02 | Day |
Unpublished
Completed
2011 | Year | 05 | Month | 13 | Day |
2011 | Year | 06 | Month | 01 | Day |
2011 | Year | 06 | Month | 02 | Day |
2015 | Year | 04 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006750
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