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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

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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
Japan

Condition
Condition Gastric cancer with peritoneal metastasis
Classification by specialty
Gastroenterology Surgery in general Gastrointestinal surgery
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
Medicine Maneuver
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
20 years-old <=
Age-upper limit
75 years-old >=
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
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
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yoshiharu
Middle name
Last name Sakai
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
Email ysakai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Okabe
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
Email 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
Email 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
2011 Year 03 Month 01 Day

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%.
Results date posted
2019 Year 04 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 02 Month 14 Day
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
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)
Adverse events
The most frequent grade 3 or 4 toxicity was neutropenia (60%).
Outcome measures
A complete response of peritoneal
metastasis was observed in 16 patients, and 14 patients
achieved R0 resection (47%;95% confidence interval
28to66%).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2011 Year 01 Month 25 Day
Date of IRB
2011 Year 04 Month 21 Day
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 22 Day
Last modified on
2019 Year 04 Month 20 Day


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


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