Unique ID issued by UMIN | UMIN000014071 |
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Receipt number | R000016370 |
Scientific Title | A phase II study of capecitabin plus cisplatin therapy for advanced gastric cancer with multiple lymph node metastases (OGSG 1401) |
Date of disclosure of the study information | 2014/05/26 |
Last modified on | 2022/09/25 16:38:31 |
A phase II study of capecitabin plus cisplatin therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1401)
A phase II study of capecitabin plus cisplatin therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1401)
A phase II study of capecitabin plus cisplatin therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1401)
A phase II study of capecitabin plus cisplatin therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1401)
Japan |
Gastric cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To confirm the efficacy and safety of capecitabin plus cisplatin combined chemotherapy (XP therapy) for advanced gastric cancer with highly metastatic nodes which cannot be resected curatively
Safety,Efficacy
Response Rate
Overall Survival (OS)
Curative operation rate
Preoperative treatment completion rate
Surgical operation completion rate
Hole treatment schedule completion rate
Histological response rate
Safety check (AE, postoperative complication)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
It takes three weeks for a one course of Cisplatin plus capecitabin combination therapy
Standard treatment is two courses before surgical operation
Cisplatin (80 mg/m2) is administered on day 1 and day 21
Capecitabin (2000 mg/m2/day: see a conversion table) is administered daily between day 1 and day 15followed by 7 days rest, and repeat one more cycle.
If the response is immature, patients can receive two more courses before surgery.
After surgical operation, TS-1 is administered for one year.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1)Histologically proven gastric carcinoma by endoscopic detection
2)HER2 negative or unknown
3)With any lesion written below by upper abdominal enhanced CT:
1.Paraaortic node metastases (#16a2/16b1) larger than 10mm
2.Bulky lymph node metastases located at celiac axis, common hepatic artery, splenic artery and/or upper mesenteric vein which make a huge bulk larger than 3.0 cm and/or multiple
large bulks larger than 1.5 cm
3.Paraaortic and bulky metastatic nodes
4)Without any lesions written below by thoratic, upper abdominal and pelvic enhanced CT:
1.mediastinal node metastases
2.lung metastases
3.peritoneal metastases
4.liver metastases
5.pleural fluid and/or ascites
6.paraaortic nodes metastases (# 16a1 and/or #16b2)
7.Other distant nodes metastases and/or CY1
5) Not a large type 3 or type 4 gastric cancer
Large: the size of cancer is larger than 8 cm
6)Without esophageal invasion longer than 3 cm
7)Not a remnant gastric cancer
8)Without cervical nodes metastases and/or distant metastases
9)Age between 20 and 75 years old
10)An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
11) Without any prior chemotherapy, radiation therapy and/or hormone therapy for the gastric cancer and/or any other cancers
12)Without prior surgical therapy except EMR/ESD and/or bypass
13) Patients can take food orally with /without bypass
14) With good functions of important organs by a data taken within 2 weeks
of registration
a) WBC: =>4000/mm3
b) Neutrophil: =>1,500/mm3
c) Hemoglobin: =>8.0 g/dl without blood transfusion
d) Platelet: =>100,000/mm3
e) AST, ALT: =< 100 IU/L
f) T.bil.: =<1.5 mg/dL
g) S-cleatinine: =<1.2mg/dL
h) Creatinine clearance: =>60 ml/min/body
CC by Cockcroft-Gault method is available:=>60mL/min 15) With written Informed Consent
1)With active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period
2)Pregnant or nursing female
3)Male expecting pregnancy of partner
4)Impossible to register to the study due to a psychological disorder by physician in charge's decision
5)Under continuous steroids medication
6)Patients who receives systemic continuous administration of flucytosine, phenytoin or warfarin
7)With neuropathy on peripheral motor and/or sensory nerves: -> glade 2 of CTCAE v4.0
8)With interstitial pneumonitis, pulmonary fibrosis and/or severe pulmonary
emphysema
9)With active bacterial/fungal infectious disease (with a fever over 38 centigrade)
10)With a history of cardiac infarction and/or anxiety angina pectoris within 6 months
11)With uncontrollable blood hypertension
12)With uncontrollable DM
13)Any other patients whom the physician in charge of the study judges to
be unsuitable
30
1st name | |
Middle name | |
Last name | Yutaka Kimura |
Kindai University School of Medicine
Department of Surgery
377-2, Ohnohigashi , Osakasayama, Osaka, 589-8511, Japan
072-366-0221
you-kimura@surg.med.kindai.ac.jp
1st name | |
Middle name | |
Last name | Hiroshi Furukawa |
Kinki University School of Medicine
Department of surgery
377-2, Onohigashi, Osakasayama, Osaka, 589-8511,Japan
072-366-0221
hiroshi.furukawa@tokushukai.jp
Osaka Gastrointestinal cancer chemotherapy Study Group(OGSG)
Osaka Clinical Study Supporting Organization
Self funding
NO
関西労災病院(兵庫県)、大阪医療センター(大阪府)
2014 | Year | 05 | Month | 26 | Day |
http://www.pieronline.jp/content/article/0385-0684/47030/481;jsessionid=108u3erjag4ai.x-sunmedia-liv
Published
http://www.pieronline.jp/content/article/0385-0684/47030/481;jsessionid=108u3erjag4ai.x-sunmedia-liv
4
The study terminated after the enrollment of 4 cases.
The test was safe to conduct, but difficult to assess its efficacy.
2022 | Year | 07 | Month | 24 | Day |
Average age 62 years old (56-71)
4 cases registered
Surgery performed in 2 cases
Pre-operation (G3 and above)
1 case of neutropenia
1 case of decreased hemoglobin
Perioperative period (G3 and above)
1 case of intra-abdominal abscess
1 case of pancreatic leak
50% response rate (1 case of PR , 2 cases of NE)
75% of radical resection (3 cases of RO/R1, 1 case of non-excision)
25% histological response rate (1 case of GO, 1 case of G1a, 1 case of G2a, 1 case of NE)
Terminated
2014 | Year | 03 | Month | 23 | Day |
2014 | Year | 05 | Month | 13 | Day |
2015 | Year | 04 | Month | 07 | Day |
2017 | Year | 11 | Month | 17 | Day |
2018 | Year | 01 | Month | 29 | Day |
2014 | Year | 05 | Month | 26 | Day |
2022 | Year | 09 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016370
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