UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004932 |
|---|---|
| Receipt number | 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 22:12:33 |
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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
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
hokabe@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Surgery
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005871
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