UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004787 |
|---|---|
| Receipt number | R000005699 |
| Scientific Title | Phase II study for evaluation of volume reduction surgery for Stage IV advanced gastric cancer effectively treated with S-1 based combination chemotherapy |
| Date of disclosure of the study information | 2010/12/24 |
| Last modified on | 2024/01/05 13:11:39 |
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Basic information
Public title
Phase II study for evaluation of volume reduction surgery for Stage IV advanced gastric cancer effectively treated with S-1 based combination chemotherapy
Acronym
PerSeUS-GC01
Scientific Title
Phase II study for evaluation of volume reduction surgery for Stage IV advanced gastric cancer effectively treated with S-1 based combination chemotherapy
Scientific Title:Acronym
PerSeUS-GC01
Region
| Japan |
Condition
Condition
StageIV gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and efficacy of volume reduction surgery for Stage IV advanced gastric cancer effectively treated with S-1 based combination chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of postoperative complications
Key secondary outcomes
overall survival, progression-free survival, histological response, resection rate, response rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Selection of chemotherapy
1)S-1 is administered orally at the dose of 80 mg/m2/day b.i.d. for 14 days, followed by 7 days of rest. Docetaxel is administered i.v. at the dose of 40 mg/m2 on day 1. Repeat 4-6 cycles.
2)S-1 is administered orally at the dose of 80 mg/m2/day b.i.d. for 21 days, followed by 14 days of rest. Cisplatin is administered i.v. at the dose of 60 mg/m2 on day 8. Repeat 2-4 cycles.
Patients who have responded to chemotherapy are consecutively subjected to surgical resection.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically confirmed gastric carcinoma
2)Advanced StageIV gastric cancer
3)Age of 20 years or older
4)No history of gastrectomy
5)No prior radiotherapy and chemotherapy
6)Measurable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST)
7)No brain metastasis
8)ECOG PS 0 to 1
9)S-1/docetaxel or S-1/cisplatin combination therapy is possible
10)Expected survival over 3 months
11)Adequate organ functions
12)Written informed consent
Key exclusion criteria
1)History of severe hypersensitivity (allergy) to any medicines
2)Administration contraindication of S-1 and combination agent
3)Continuous use of flucytosine, phenytoin or warfarin potassium
4)Active infection
5)Severe complications, such as intestinal paralysis, ileus, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure and hepatic failure
6)Watery stools or diarrhea
7)Massive pleural or abdominal effusion
8)Active double cancer
9)Pregnant or nursing females.
10)Males who are planning partners' pregnancy.
11)Not suitable for participation with any other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YOSHIDA, Kazuhiro |
Organization
Gifu University, Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
1-1 Yanagido, Gifu 501-1194, Japan
TEL
058-230-6235
surgonco@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YAMAGUCHI, Kazuya |
Organization
Gifu University, Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
1-1 Yanagido, Gifu 501-1194, Japan
TEL
058-230-6235
Homepage URL
surgonco@gifu-u.ac.jp
Sponsor or person
Institute
PerSeUS-GC
Institute
Department
Personal name
Funding Source
Organization
PerSeUS-GC
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gifu Municipal Hospital
Gifu Prefectural Medical Center
Hiroshima University
Kanazawa Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2010 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005699
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