Unique ID issued by UMIN | UMIN000028749 |
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Receipt number | R000032844 |
Scientific Title | A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases (OGSG 1701) |
Date of disclosure of the study information | 2017/09/01 |
Last modified on | 2022/08/28 17:59:57 |
A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1701)
A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1701)
A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1701)
A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases
(OGSG 1701)
Japan |
Gastric Cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To confirm the efficacy and safety of perioperative Capecitabine plus Oxaliplatin combined chemotherapy (CapeOx) for advanced gastric cancer with multiple lymph node metastases which cannot be resected curatively, or very poor prognosis.
Safety,Efficacy
Phase II
Response Rate(RR)(RECISTv1.0)
1.Overall survival(OS)
2.Progression free survival
3.Rate of curative resection
4.Complete rate of protocol
5.Complete rate of preoperative chemotherapy
6.Complete rate of operation
7.Complete rate of postoperative chemotherapy
8.Relative Dose Intensity (RDI)
9.Response Rate of Histologically
10.Incidence of adverse events on perioperative chemotherapy
11.Incidence of a intraoperative and postoperative complication
12.Response Rate (RR)(RECISTv1.1)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Other |
preoperative CapeOx therapy
Capecitabine : 1,000mg/m2 bid, day1-14, q3w
Oxaliplatin : 130mg/m2, day 1, q3w
3 cycle
Surgery
Postoperative CapeOx therapy
Capecitabine : 1,000mg/m2 bid, day1-14, q3w
Oxaliplatin : 130mg/m2, day 1, q3w
5 cycle
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.
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
1.Neutrophil: =>1,500/mm3
2.Hemoglobin: =>8.0 g/dL without blood transfusion
3.Platelet: =>100,000/mm3
4.AST, ALT: =< 100 IU/L
5.T.bil.: =<2.0 mg/dL
6.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 phenytoin or warfarin potassium
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)With uncontrollable Diarrhea
14)Positive HBs antigen
15)Severe complications
16)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 | Naotoshi Sugimoto |
Osaka International Cancer Institute
Department of medical oncology
3-1-69, Otemae, chuoh-ku, Osaka, 541-8567, Japan
06-6945-1181
sugimoto-na2@mc.pref.osaka.jp
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Yakult Honsha Co.,Ltd.
Profit organization
NO
市立東大阪医療センター(大阪府)、近畿大学(大阪府)、佐野病院(兵庫県)、関西労災病院(兵庫県)、箕面市立病院(大阪府)、大阪医科大学附属病院(大阪府)、相澤病院
2017 | Year | 09 | Month | 01 | Day |
Unpublished
30
No longer recruiting
2017 | Year | 06 | Month | 30 | Day |
2017 | Year | 09 | Month | 06 | Day |
2018 | Year | 02 | Month | 02 | Day |
2025 | Year | 06 | Month | 12 | Day |
2017 | Year | 08 | Month | 20 | Day |
2022 | Year | 08 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032844
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