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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000004932 |
Receipt No. | R000005871 |
Scientific Title | A Phase II study of induction chemotherapy with docetaxel, S-1 and cisplatin (DCS) for advanced gastric cancer with peritoneal metastasis (KUGC06) |
Date of disclosure of the study information | 2011/03/01 |
Last modified on | 2019/04/20 |
Basic information | ||
Public title | A Phase II study of induction chemotherapy with docetaxel, S-1 and cisplatin (DCS) for advanced gastric cancer with peritoneal metastasis (KUGC06) | |
Acronym | A phase II study of DCS chemotherapy for advanced gastric cancer with peritoneal metastasis(KUGC06) | |
Scientific Title | A Phase II study of induction chemotherapy with docetaxel, S-1 and cisplatin (DCS) for advanced gastric cancer with peritoneal metastasis (KUGC06) | |
Scientific Title:Acronym | A phase II study of DCS chemotherapy for advanced gastric cancer with peritoneal metastasis(KUGC06) | |
Region |
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Condition | ||||
Condition | Gastric cancer with peritoneal metastasis | |||
Classification by specialty |
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Classification by malignancy | Malignancy | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate safety and efficacy of induction chemotherapy with Docetaxel+S-1+CDDP for gastric cancer with peritoneal metastasis |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | R0 resection ratio |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 1 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | Chemotherapy+Surgery | ||
Interventions/Control_2 | |||
Interventions/Control_3 | |||
Interventions/Control_4 | |||
Interventions/Control_5 | |||
Interventions/Control_6 | |||
Interventions/Control_7 | |||
Interventions/Control_8 | |||
Interventions/Control_9 | |||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Pathologically confirmed gastric cancer
2)Gross or microscopic peritoneal metastasis confirmed by laparoscopy 3)No distant metastasis detected by CT or MRI 4)No previous treatment 5)Age between 20 and 75 years old 6ECOG 0 or 1 7)Capable of oral administration 8)Informed concent 9)Biology and biochemistry within normal limits |
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Key exclusion criteria | 1)Active bleeding from the tumor
2)Paralysis of intestine or ileus 3)Diarrhea(watery stool) 4)Synchronous multicancer 5)Serous infection 6)Interstitial pneumonitis or fibroid lung 7)Ascites requiring control or peritoneal metastasis detected by CT 8)Uncontrollable diabetes mellitus 9)Uncontrollable hypertention, heart insufficiency, myocardial infarction within 6 months,uncontrolled arrhythmia or angina 10)Patient who is pregnant or in lactation, or wish to become pregnant during this study.Male patient who intends to make someone pregnant during this study 11)Patient who has experienced serious drug allergy in the past 12)Patient with severe phyciatric disease 13)Patient who requires continuous use of flucytosine, phenytoin 14)HBsAb positive 15)Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Graduate School of Medicine, Kyoto University | ||||||
Division name | Department of Surgery | ||||||
Zip code | 6068507 | ||||||
Address | 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN | ||||||
TEL | 075-366-7595 | ||||||
ysakai@kuhp.kyoto-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Graduate School of Medicine, Kyoto University | ||||||
Division name | Department of Surgery | ||||||
Zip code | 6068507 | ||||||
Address | 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN | ||||||
TEL | 075-366-7595 | ||||||
Homepage URL | |||||||
hokabe@kuhp.kyoto-u.ac.jp |
Sponsor | |
Institute | Department of Surgery
Graduate School of Medicine, Kyoto University |
Institute | |
Department |
Funding Source | |
Organization | Department of Surgery
Graduate School of Medicine, Kyoto University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Kyoto University Ethics comittiee |
Address | Yohida Konoe-cho, Kyoto |
Tel | 075-753-4680 |
ethcom@kuhp.kyoto-u.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 京都大学医学部付属病院(京都府)
京都医療センター(京都府) 大阪赤十字病院(大阪府) 北野病院(大阪府) 天理よろづ相談所病院(奈良県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | https://link.springer.com/article/10.1245%2Fs10434-019-07229-7 |
Publication of results | Partially published |
Result | |||||||
URL related to results and publications | https://link.springer.com/article/10.1245%2Fs10434-019-07229-7 | ||||||
Number of participants that the trial has enrolled | 30 | ||||||
Results | Among 30 enrolled patients, 24 completed three cycles of DCS. The most frequent grade 3 or 4 toxicity was neutropenia (60%). A complete response of peritoneal metastasis was observed in 16 patients, and 14 patients achieved R0 resection (47%; 95% confidence interval 28to66%). When the extent of peritoneal metastasis was classified as P0CY1, P1, P2, and P3 according to the Japanese classification, the R0 resection rates were respectively 63%, 60%, 46% and 0%. |
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Results date posted |
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Results Delayed | |||||||
Results Delay Reason | |||||||
Date of the first journal publication of results |
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Baseline Characteristics | No. of patients 30 Median age: years (range) 60 (42to73) Sex Male 15 Female 15 Performance status 0 23 1 7 Histology Differentiated 6 Undifferentiated 24 Macroscopic types 1 1 2 3 3 9 4 16 5 1 T category T3 (SS) 1 T4a (SE) 25 T4b (SI) 4 N category N0 5 N1 7 N2 15 N3 3 CY category CY0 8 CY1 19 CYX 3 P category P0 8 P1 5 P2 13 P3 4 PC stages 0 8 1 3 2 13 3 6 4 0 |
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Participant flow | All enrolled pts (n = 30) Eligible (n = 29) Induction CTX (n = 30) Induction CTX Ineligible (n = 1) - Paraaortic lymph node metastasis Incomplete CTX (n = 6) - Severe adverse event (n = 1) - Patient refusal (n = 2) - Delayed recovery (n = 1) completed (n = 24) - Other reasons (n = 2) Surgery (n = 21) Not operated (n = 9) R0 resection (n = 14)* R1/2 resection (n = 7) |
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Adverse events | The most frequent grade 3 or 4 toxicity was neutropenia (60%). |
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Outcome measures | A complete response of peritoneal metastasis was observed in 16 patients, and 14 patients achieved R0 resection (47%;95% confidence interval 28to66%). |
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Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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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=R000005871 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |