Unique ID issued by UMIN | UMIN000016256 |
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Receipt number | R000018781 |
Scientific Title | A phase II study of capecitabin plus oxaliplatin therapy (XELOX) for inoperable/advanced gastric cancer resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11 (OGSG1403) |
Date of disclosure of the study information | 2015/01/19 |
Last modified on | 2020/09/06 16:02:07 |
A phase II study of capecitabin plus oxaliplatin therapy (XELOX) for inoperable/advanced gastric cancer resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11 (OGSG1403)
A phase II study of capecitabin plus oxaliplatin therapy (XELOX) for inoperable/advanced gastric cancer resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11 (OGSG1403)
A phase II study of capecitabin plus oxaliplatin therapy (XELOX) for inoperable/advanced gastric cancer resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11 (OGSG1403)
A phase II study of capecitabin plus oxaliplatin therapy (XELOX) for inoperable/advanced gastric cancer resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11 (OGSG1403)
Japan |
unresectable/advanced gastric cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To confirm the efficacy and safety of capecitabin plus oxaliplatin combined chemotherapy (XELOX therapy) for unresectable/advanced gastric cancer
resistant/intolerable to fluoro-pyrimidine, CDDP, Taxane or CPT-11.
Safety,Efficacy
Disease Control Rate
Overall Survival, Progression Free Survival, Time To Failure, Response Rate, Incidence of Adverse Events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
It takes three weeks for a one course of oxaliplatin plus capecitabin combination therapy (XELOX). Patients undergo this treatment until progression or severe AE.
20 | years-old | <= |
Not applicable |
Male and Female
1)histologically proven gastric carcinoma or adenocarcinoma on the esophago-gastric junction
2)resistant /intolerable to fluoropyrimydine, CDDP, CPT-11 or Taxane
3)age over than 20 years old
4)Performance Status by Eastern Cooperative Oncology Group of 0,1 or 2.
5)with measurable lesions (RESIST ver. 1.1)
6)Patients who can take food orally
7)expected survival period longer than 3 months
8)with a rest longer than 14 days after the end of prior therapy
9) with good functions of important organs
1. Neutrophil: =>1,500/mm3
2. Hemoglobin: =>8.0 g/dl without blood transfusion within 14 days
3. Platelet: =>100,000/mm3
4. AST, ALT: =< 100 IU/L
5. T.bil.: =<1.5 mg/dL
6. s-cleatinine: =<1.2mg/dL
10) with a peripheral neuropathy lower than Grade 1
11) with written Informed Consent
1)With prior chemotherapy including oxaliplatin (L-OHP)
2)With some active double cancers
3)With severe complications
4)With active infectious diseases which need treatments
5)With thoracic fluid and/or ascites which need drainage
6)under continuous steroids medication
7)under medication of phenytoin and/or warfarin
8)with active bleeding which needs frequent blood transfusion
9)with central nerve metastases with symptoms
10) with psychological disorders
11) Pregnant and/or nursing women or men who like to have children
12)Any other patients whom the physician in charge of the study judges to be unsuitable
30
1st name | |
Middle name | |
Last name | Naotosi 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
1st name | |
Middle name | |
Last name | Naotosi 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)
Osaka Clinical Study Supporting Organization
Self funding
NO
箕面市立病院(大阪府)、市立貝塚病院(大阪府)、大阪国際がんセンター(大阪府)、北野病院(大阪府)、関西労災病院(兵庫県)、大阪医療センター(大阪府)
2015 | Year | 01 | Month | 19 | Day |
Unpublished
12
Delay expected |
manuscript in preparation
Terminated
2014 | Year | 11 | Month | 10 | Day |
2015 | Year | 03 | Month | 20 | Day |
2015 | Year | 07 | Month | 27 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 01 | Month | 28 | Day |
2015 | Year | 01 | Month | 18 | Day |
2020 | Year | 09 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018781
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