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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000104 |
Receipt No. | R000000153 |
Scientific Title | A randomized phase II (/III) study of TXT/TS-1 (DS) combination vs CDDP/5-FU therapy (FUP) in metastatic gastric cancer |
Date of disclosure of the study information | 2005/10/01 |
Last modified on | 2011/09/18 |
Basic information | ||
Public title | A randomized phase II (/III) study of TXT/TS-1 (DS) combination vs CDDP/5-FU therapy (FUP) in metastatic gastric cancer | |
Acronym | A randomized phase II study of TXT/TS-1 (DS) vs CDDP/5-FU (FUP) in metastatic gastric cancer | |
Scientific Title | A randomized phase II (/III) study of TXT/TS-1 (DS) combination vs CDDP/5-FU therapy (FUP) in metastatic gastric cancer | |
Scientific Title:Acronym | A randomized phase II study of TXT/TS-1 (DS) vs CDDP/5-FU (FUP) in metastatic gastric cancer | |
Region |
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Condition | ||
Condition | Chemotherapy-naïve metastatic gastric cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | To compare docetaxel plus S-1 combination (DS) with CDDP/5-FU (FUP) for chemotherapy-naïve patients with advanced or recurrent gastric cancer |
Basic objectives2 | Bio-equivalence |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II,III |
Assessment | |
Primary outcomes | Tumor response rate |
Key secondary outcomes | 1)Duration of a CR, PR, or SD
2)Progression free-survival (PFS) and time to treatment failure (TTF) 3)Median overall survival (MST), 1- and 2-year survival rate, 4)Adverse events 5)Possible Biomarker a)Association of genotype, mutation, and expression of ABCB1, CYP3A4, GSTP1, POR, TUBB, DPYD, and TYMS with phenotype b)Development of efficacy prediction model using ABCB1, ABCG2, CYP2C8, CYP3A4, DPYD, GSTP1, MGMT, NQO1, POR, TOP2A, TUBB, and TYMS c)Identification of possible biomarker genes other than ABCB1, CYP3A4, GSTP1, POR, TUBB, DPYD, and TYMS |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Intravenous administration of 40 mg/m2 docetaxel on Day 1 and oral administration of 80 mg/m2/day S-1 on Days 1 to 14 every 3 weeks | |
Interventions/Control_2 | Intravenous continuous administration of 5-FU 800 mg/m2/day on Day 1 to Days 5 and intravenous administration of 80 mg/m2/day CDDP on Day 2 every 4 weeks | |
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Eligibility | ||||
Age-lower limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1)With pathologically proven gastric cancer
(2)With at least one measurable lesion (RECIST) (3)No prior irradiation and chemotherapy or 1 adjuvant chemotherapy regimen that was completed >=28 days prior to entry (4)ECOG performance status<=2 (5)Age 20-75 years (6)Life expectancy estimated>=12 weeks (7)With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. Defined as: white blood cell count>=4000 mm3<=12,000 mm3, neutrophil count>=2000 mm3, hemoglobin>=9.0 g/dl, platelet>=100,000 mm3, AST and ALT within two times the upper limit of normal for the institution, serum bilirubin level<=1.5 mg/dl, BUN<=25 mg/dl, serum creatinine level<=1.5 mg/dl, creatinine clearance>=60 ml/min. (8)With written informed consent |
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Key exclusion criteria | (1)Accompanied serious diseases
(2)Prior adjuvant chemotherapy including a taxane, TS-1, CDDP and 5-FU (3)Oral uptake disturbance (4)A past history of drug allergy (5)A past history of allergic reaction to polysorbate 80 (6)Symptomatic pleural effusion or ascites (7)Symptomatic infectious disease (8)Watery diarrhea (9)Ileus and obstructive bowel disease (10)Pulmonary fibrosis, interstitial pneumonia, symptomatic bleeding tendency, and Hemorrhage/bleeding>=grade 3 (NCI- CTC) (11)Peripheral neuropathy>=grade 2 (12)Edema>=grade 2 (13)Concomitant therapy with flucytocine (14)Active secondary cancer (15)Uncontrollable diabetes (16)Congestive heart failure, symptomatic ischemic heart disease, poorly controlled arrhythmia, A-V block>=grade 2, myocardial infarction cooured within 12 months (17)Symptomatic psychological disease (18)Pregnancy or breast feeding (19)Decision as ineligible by principal investigator |
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Target sample size | 130 |
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Name of lead principal investigator |
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Organization | Research Institute for Radiation Biology and Medicine, Hiroshima University | ||||||
Division name | Department of Translational Cancer Research | ||||||
Zip code | |||||||
Address | 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan | ||||||
TEL | 082-257-5839 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Research Institute for Radiation Biology and Medicine, Hiroshima University | ||||||
Division name | Department of Translational Cancer Research | ||||||
Zip code | |||||||
Address | 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan | ||||||
TEL | 082-257-5839 | ||||||
Homepage URL | http://www.hictdo.or.jp/tiken.html | ||||||
info@hictdo.or.jp |
Sponsor | |
Institute | Hiroshima Cancer Therapy Development Organization (HiCTDO) |
Institute | |
Department |
Funding Source | |
Organization | Hiroshima Cancer Therapy Development Organization (HiCTDO) |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Hokkaido Univ, Asahikwa-Kosei General Hosp,Hakodate Goryoukaku Hosp,Nishi Sapporo Natl Hosp, Sapporo Social Insurance General Hosp, Sakai City Hosp, Hiroshima Univ, Okayama Univ, Saitama Medcl College |
Name of secondary funder(s) | None |
IRB Contact (For public release) | |
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Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | HiCTDO protocol #4 |
Org. issuing International ID_1 | Hiroshima Cancer Therapy Development Organization (HiCTDO) |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | http://www.hictdo.or.jp/tiken.html |
Publication of results | Unpublished |
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000153 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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