UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Acronym	A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Scientific Title	A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Scientific Title:Acronym	A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Region	Japan

Condition
Condition	advanced gastric cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A feasibility on completion of four courses of S-1 and CPT-11 after gastric resection is evaluated to make the following phase III study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Patients ratio with 4 course completion
Key secondary outcomes	1.Patients ratio with one year course completion 2.Incidence of adverse events 3.Recurrence Free Survival 4. Overall Survival

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
Interventions/Control_1	CPT-11 80mg/m2 is administered by drip infusion on day 1. TS-1 (BSA<1.25 40mg/body/once,1.25<=BSA<1.5 50mg/body/once,BSA>=1.5 60mg/body/ once) is administered twice a day orally between day 1 and day 21. It takes 35 days for the one course.
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	Eligible criteria 1. primary gastric cancer diagnosed pathologically. 2. Final curability is B with D2 or D3 lymph node dissection 3. Stage IIIA(T2-N2,T3-N1 or T4-N0) or Stage IIIB(T3-N2 or T4-N1) 4. without any prior treatment for cancer 5. 4-8 weeks interval between surgical operation and following chemotherapy 6. age : 20-75 year old 7. performance status (ECOG):0-1 8. patients who can eat orally 9. without any severe disorder on the organs and with the data satisfied the following criteria measured within 2 weeks of registration 1) WBC >=4,000/mm3 and <12,000mm3 2) Neutrocyte >=2,000/mm3 3) Platelet >=100,000/mm3 4) Hg >=8.0g.dl 5) T.bil <=1.5mg/dl 6) GOT, GPT <=100 IU/l 7) sCr <=1.2mg/dl 10. written informed consent
Key exclusion criteria	Ineligible criteria 1.A fresh bleeding on the digestive tract 2.Severe allergy against medicines or history of allergy 3.with active double cancer 4.with uncontrollable cavity fluid 5.with some infectious diseases and/or febrile condition 6.with brain metastases 7.with some disorders on ECG 8.with heart diseases such as congestive heart failure, symptomatic coronary dysfunction, uncontrollable arrhythmia, infarction/history of infarction 9.with liver cirrhosis and/or active hepatitis 10.with DM uncontrollable 11.with severe pulmonary diseases such as interstitial pneumonia,Pulmonary fibrosis 12.uncontrollable diarrhea 13.under intestinal paralysis or ileus 14.patients with psychological disorder who seems difficult to undergo treatment 15. under medication of ATAZANABIL 16. under continuous medication of steroids 17. with continuous medication of fluoro-pyrimidine, flusitosine, fenitoin,and/or Warfarin 18. pregnant and/or nursing women or patients who like to have children 19. patient who seems difficult to undergo protocol treatment
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Fujitani Kazumasa
Organization	National Hospital Organization Osaka National Hospital
Division name	Dpt. surgery
Zip code
Address	2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006
TEL	06-6942-1331
Email

Public contact
Name of contact person	1st name Middle name Last name Fujitani Kazumasa
Organization	National Hospital Organization Osaka National Hospital
Division name	Dpt. surgery
Zip code
Address	2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006
TEL	06-6942-1331
Homepage URL
Email

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

Funding Source
Organization	Osaka Clinical Study Supporting 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

Other administrative information
Date of disclosure of the study information	2009 Year 07 Month 10 Day

Related information
URL releasing protocol	https://www.karger.com/Article/Abstract/329090
Publication of results	Published

Result
URL related to results and publications	https://www.karger.com/Article/Abstract/329090
Number of participants that the trial has enrolled	53
Results	A total of 42 patients (79.2%, 95% CI 65.9-82.9) tolerated the planned 4 cycles of treatment with S-1 and docetaxel, and 34 patients (64.2%, 95% CI 49.8-76.9) completed subsequent S-1 monotherapy for 1 year.
Results date posted	2022 Year 11 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 06 Month 18 Day
Baseline Characteristics	pathological stage III gastric cancer who underwent D2 gastrectomy
Participant flow	We enrolled 53 patients. A total of 42 patients tolerated the planned 4 cycles of treatment with S-1 and docetaxel, and 34 patients completed subsequent S-1 monotherapy for 1 year.
Adverse events	Grade 4 neutropenia was observed in 28% and grade 3 febrile neutropenia in 9% of the patients, while grade 3 nonhematological toxicities were relatively low.
Outcome measures	tolerance of the planned 4 cycles of treatment with S-1 and docetaxel
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 11 Month 20 Day
Date of IRB	2008 Year 11 Month 20 Day
Anticipated trial start date	2008 Year 12 Month 25 Day
Last follow-up date	2013 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	2009 Year 07 Month 10 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=R000001829