Unique ID issued by UMIN | UMIN000000677 |
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Receipt number | R000000814 |
Scientific Title | Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701) |
Date of disclosure of the study information | 2007/04/19 |
Last modified on | 2021/11/14 18:11:33 |
Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)
Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)
Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)
Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)
Japan |
progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
To compare the effectiveness and feasibility among CPT-11, TXL or combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/platinum compounds(CDDP or OHP) chemotherapy
Safety,Efficacy
Overall survival time.
To determine the qualitative and quantitative toxicity and reversibility of toxicity of each chemotherapeutic regimen.
To estimate antitumor activity.
To estimate the progression free survival time.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Institution is not considered as adjustment factor.
Central registration
4
Treatment
Medicine |
A:CPT-11(150mg/m2/day,day1) every 2 weeks
B:TXL (80mg/m2, day1,8,15) every 4 weeks
C:TS-1 (80-120mg/day, day1-21), CPT-11(80mg/m2/day, day1,15) every 5 weeks.
D:TS-1 (80-120mg/day, day1pm~day15am), TXL( 50mg/m2/day, day1,8) every 3 weeks.
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Patients who have not received prior antitumor chemotherapies without S-1 or S-1/CDDP treatment, immunotherapy, or radiotherapy (including local irradiation for pain control) as primary chemotherapy.
2) Patients who had received resistant for prior antitumor chemotherapy with S-1 or S-1/CDDP treatment as primary chemotherapy in whom either (a) or (b) below are diagnosed to be present by the principal investigator of the trial.
(a) Advanced gastric cancer in which a new lesion or progression has been observed by diagnostic imaging after TS-1 monotherapy or TS-1/CDDP combination chemotherapy (either therapy for 4weeks or more) as primary chemotherapy for gastric cancer.
(b) Recurrence during postoperative chemotherapy by TS-1 monotherapy or within 26 weeks of its completion.
3) Patients in whom at least 2 weeks has passed since the completion of the previous chemotherapy.
4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1, 2 or less.
5) A predicted life expectancy of at least 3 months.
6) Preservation of major organ function to satisfy the following : leukocyte count of >=4,000 to <12,000 mm3 ; platelet count of >= 100,000/mm3 ; hemoglobin of >=8.0 g/dl ; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels of <=100 IU/l *Except that even if the AST or ALT value does not fulfill this criterion, if the value is diagnosed to be attributable to the primary disease, such as liver metastasis, the criterion will be no more than 150 IU/l. ; alkaline phosphatase of <=x2 the upper limit of the normal range (ULN) ; serum bilirubin level of <=1.5 mg/dl ; serum creatinine of <=1.2 mg/dl or creatinine clearance level of >=50ml/min (When available, the actual measurement will be used as the eligibility criterion, but the value obtained by using the Cockcroft-Gault formula can also be used)
7) Written informed consent to participate in this study
1) Have a double cancer patient
2) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc.
3) Infectious disease
4) Diarrhea (watery stools)
5) Ascites or pleural effusion
6) History of serious drug hypersensitivity (especially such as cyclosporine preparations, containing polyoxyethylene castor oil [Cremophor EL], or such as [vitamin preparations for injection] containing hydrogenated castor oil.
7) Undergoing treatment with other fluoropyrimidine anticancer agents, fluorocytosine, or atazanavir sulfate.
8) Found to have fresh gastrointestinal bleeding that requires repeated transfusion.
9) With liver cirrhosis or jaundice.
10) Undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment.
11) having heart disease, such as ischemic heart disease or an arrhythmia, severe enough to require treatment.
12) With diabetes that is difficult to control.
13) With central nervous system metastasis
14) Pregnant, breast-feeding, or who wish to undergo artificial insemination
15) Any other patient whom the physician in charge of the study judges to be unsuitable
120
1st name | |
Middle name | |
Last name | Imamura Hiroshi |
Sakai City Hospital
Department of surgery
1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
072-221-1700
1st name | |
Middle name | |
Last name | Hiroshi Furukawa |
Kinki University Faculty of Medicen
Department of surgery
377-2, Onohigashi, Osakasayama, Osaka, Japan
072-366-0221
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Osaka Clinical Study Supporting Organization
Self funding
NO
2007 | Year | 04 | Month | 19 | Day |
https://link.springer.com/article/10.1007%2Fs10147-021-01984-y
Published
https://link.springer.com/article/10.1007%2Fs10147-021-01984-y
127
No difference in median OS was observed in the irinotecan vs. paclitaxel groups or in the monotherapy groups vs. the S-1 combination therapy groups for advanced gastric cancer (AGC). Median PFS was longer in the paclitaxel group compared with the irinotecan group (4.1 vs. 3.6 months, p = 0.035), although no difference was observed when comparing monotherapy vs. S-1 combination.
2021 | Year | 11 | Month | 14 | Day |
2021 | Year | 08 | Month | 28 | Day |
Patient for advanced gastric cancer (AGC) that is refractory to S-1 or S-1 plus CDDP (SP)
Patients with AGC after first-line chemotherapy with S-1 or SP, or patients during adjuvant chemotherapy, or within 26 weeks after adjuvant chemotherapy completion with S-1 with confirmed disease progression were eligible. Patients were randomly divided into four groups based on treatment.
From July 2008 to March 2012, 127 patients were enrolled.
The most common grade 3 to 4 hematological adverse events were neutropenia with no difference in incidence rate across the treatment groups.
overall survival
Completed
2007 | Year | 02 | Month | 19 | Day |
2007 | Year | 04 | Month | 10 | Day |
2007 | Year | 07 | Month | 24 | Day |
2014 | Year | 03 | Month | 08 | Day |
2014 | Year | 07 | Month | 28 | Day |
2007 | Year | 04 | Month | 12 | Day |
2021 | Year | 11 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000814
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