UMIN-CTR Clinical Trial

Basic information
Public title	A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Acronym	A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Scientific Title	A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Scientific Title:Acronym	A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The durability and feasibility of 6 months continuous DTX+TS-1 administration after R0 gastrectomy is detected in the patients with Stage lllA/lllB gastric ccancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	six months durability rate of TS-1 administration
Key secondary outcomes	Overall survival, Deasease-free survival, Advers events, Twelve months durability of TS-1 administration

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
Interventions/Control_1	DTX and TS-1 are administrated 45 days after R0 operation. One course includes Docetaxel 40mg/m2 on day 1 + TS-1 80mg/m2 between day 1 and day 14, and 7 days rest.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)gastric cancer proven histologically 2)Patients who underwent D2 lymph node dissection to be curative operation 3)gastric cancer in Stage lllA or lllB by the japanese Classification pf Gastric Carcinoma(The 13th Edition) 4)patients older than 20 y.o. and younger than 80 y.o. 5)PS(ECOG)=0-1 6)without any treatment before(radiation therapy, Chemotherapy and/or hormone therapy) 7)patients who can take mesicine orally 8)without any severe complications and limited in the following date WBC : 3,000/mm3<= and >=12,000/mm3 Neutrophile : 2,000/mm3 Hemoglobin : 9.0g/dl<= Platelet : 100,000/mm3 T.bil. : 1.5mg/dl>= AST,ALT : 100IU/L>= creatinine : 1.2mg/dl 9)with written Informed Consent
Key exclusion criteria	1)Patients with double cancers (simultaneous or different time) Following cases are eligeble : 1.carcinoma in situ of cervical cancer and/or focal colon cancer in adenoma 2.small multiple cancers whose stages are lower than main cancer 3.double early cancers removed by EMR/EDS 2)patients who has contraindication to TS-1 3)patients who need Flucitosine,Fenitoin and/or Walfarin 4)patients who have a history of severe allergy against medicine in grade 3 or 4 5)patients who have a history of severe allergy against medicine including polysolvate 80 6)with interstitial pneumonia 7)with severe diseases(intestinal paralysis, ileus, uncontrollable DM, Cardiac failure, liver dysfunction) 8)with watery diarrhea 9)Females who are pregnent,nursing or possibility of pregnancy, or have a plan to have baby in future 10)Males who have a plan to have their own baby 11)with HIV (positive) or liver cirrhosis/active hepatitis 12)Edema which needs treatment 13)patients whom doctor in chief decides not to register to this study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Fujitani Kazumasa
Organization	Osaka General Medical Center
Division name	surgery
Zip code
Address	3-1-56, Bandaihigashi, Suniyosi-ku, Osaka-City
TEL	06-6692-1201
Email	fujitani@gh.opho.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Furukawa
Organization	Kinki University School of Medicine
Division name	Department of surgery
Zip code
Address	377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL	072-366-0221
Homepage URL
Email	hiroshi.furukawa@tokushukai.jp

Sponsor
Institute	Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization	Osaka Clinical Study Support Organization
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
Address
Tel
Email

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	NTT西日本大阪病院（大阪府）、八尾市立病院（大阪府）、市立堺病院（大阪府）、大阪医療センター（大阪府）、市立豊中病院（大阪府）、箕面市立病院（大阪府）、関西労災病院（兵庫県）、北野病院（大阪府）、西宮市立中央病院（兵庫県）、大阪府立急性期総合医療センター（大阪府）、大阪北逓信病院（大阪府）、阪南中央病院（大阪府）、土庫病院（奈良県）、市立貝塚病院（大阪府）

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 01 Day

Related information
URL releasing protocol	https://link.springer.com/article/10.1007/s10120-019-01023-w
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s10120-019-01023-w
Number of participants that the trial has enrolled	62
Results	The completion rate for eight cycles of S-1 plus docetaxel(DS) therapy was 77.4% [95% confidence interval (CI) 65.0-87.1%]. Subsequent S-1 monotherapy for 1 year was feasible in 71.0% (95% CI 58.1-81.8%) of patients.
Results date posted	2022 Year 11 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 10 Month 30 Day
Baseline Characteristics	stage III gastric cancer(GC)
Participant flow	Sixty-two patients with stage III GC were enrolled.
Adverse events	The incidence of neutropenia, leukopenia, anorexia and fatigue of grade 3 or higher was 10% or higher.
Outcome measures	The primary endpoint was the treatment completion rate, which was defined as the percentage of patients who completed eight cycles of DS therapy. The secondary endpoints were safety, disease-free survival (DFS), OS, and feasibility of S-1 administration until 1 year after surgery.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 13 Day
Date of IRB	2010 Year 11 Month 20 Day
Anticipated trial start date	2010 Year 12 Month 14 Day
Last follow-up date	2017 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 10 Month 09 Day

Other
Other related information

Management information
Registered date	2010 Year 10 Month 25 Day
Last modified on	2022 Year 11 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005298