Unique ID issued by UMIN | UMIN000013840 |
---|---|
Receipt number | R000016148 |
Scientific Title | The feasibility study of modified XP (+ trastuzumab) for the patients who underwent gastrectomy for Stage IV gastric cancer: EXPRESS-GC study |
Date of disclosure of the study information | 2014/05/01 |
Last modified on | 2017/04/10 11:55:18 |
The feasibility study of modified XP (+ trastuzumab) for the patients who underwent gastrectomy for Stage IV gastric cancer: EXPRESS-GC study
The feasibility study of modified XP (+ trastuzumab) for the patients who underwent gastrectomy for Stage IV gastric cancer: EXPRESS-GC study
The feasibility study of modified XP (+ trastuzumab) for the patients who underwent gastrectomy for Stage IV gastric cancer: EXPRESS-GC study
The feasibility study of modified XP (+ trastuzumab) for the patients who underwent gastrectomy for Stage IV gastric cancer: EXPRESS-GC study
Japan |
gastric cancer
Surgery in general | Gastrointestinal surgery |
Malignancy
NO
To elucidate the feasibility of postoperative Capecitabine/CDDP in patients with stage IV gastric cancer or Capecitabine/CDDP with Trasutuzumab in patients with stage IV HER2 positive gastric cancer
Safety,Efficacy
Exploratory
completion rates of 4 courses treatment of Capecitabine/CDDP(+Trasutuzumab)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Capecitabine/CDDP(+Trasutuzumab)
20 | years-old | <= |
Not applicable |
Male and Female
(1) StageIV gastric cancer histologically proven to be adenocarcinoma
(2) Undergoing gastrectomy
(3) Age : 20 years old and more
(4) Performance status (ECOG) 0-1
(5) Oral drug administration during 8 postoperative weeks
(6) Adequate organ functions
(7) Life expectancy : 12 weeks and more
(8) Ability to understand and willingness to sign a written informed consent before study entry
(9) LVEF equal or more than 50% when trasutuzumab administered
(1) Second primary malignancy except in situ carcinoma or prior malignancy treated within 5 years
(2) Serious illness
(3) Severe infectious disease
(4) Active gastrointestinal bleeding
(5) Severe diarreha
(6) Past history of severe hypersensitivity to drugs
(7) Suspicious past history of DPD deficiency
(8) Contraindication for trastuzumab, capecitabine and cisplatin
(9) Requirement of continuation for phenytoin and warfarin
(10) Pregnant or lactating woman
(11) Women of child bearing potential not using a contraceptive method. Sexually active fertile men not using effective birth control.
(12) Psychological illness
(13) Any patients judged by the investigator to be unfit to participate in the study
30
1st name | |
Middle name | |
Last name | Yasuhiro Kodera |
Nagoya University, Graduate School of Medicine
Gastroenterorogical Surgery
65 Tsurumai-cho Showa-ku Nagoya city
052-744-2253
ykodera@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Daisuke Kobayashi |
Nagoya University, Graduate School of Medicine
Gastroenterorogical Surgery
65 Tsurumai-cho Showa-ku Nagoya city
052-744-2249
kobadai@med.nagoya-u.ac.jp
Chubu Clinical Oncology Group
Chubu Clinical Oncology Group
Other
NO
2014 | Year | 05 | Month | 01 | Day |
Unpublished
No longer recruiting
2014 | Year | 02 | Month | 01 | Day |
2014 | Year | 06 | Month | 01 | Day |
2014 | Year | 04 | Month | 28 | Day |
2017 | Year | 04 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016148
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |