UMIN-CTR Clinical Trial

Basic information
Public title	A Phase III Study of Docetaxel and S-1 versus S-1 in the Treatment of Advanced Gastric Cancer
Acronym	START (S-1 and Taxotere therapy for Advanced GC Randomized phase III Trial)
Scientific Title	A Phase III Study of Docetaxel and S-1 versus S-1 in the Treatment of Advanced Gastric Cancer
Scientific Title:Acronym	START (S-1 and Taxotere therapy for Advanced GC Randomized phase III Trial)
Region	Japan Asia(except Japan)

Condition
Condition	Gastric Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The primary objective of the study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	To compare median overall survival
Key secondary outcomes	•-To compare the time-to-tumor progression, defined as time from randomization to date of first documentation of Progressive Disease •-To compare the clinical response, according to RECIST •To evaluate the safety of the two regimens

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Docetaxel: 40 mg/m2 (1 hour IV infusion) on Day 1 of each cycle S-1: target dose of 80 mg/m2/day (orally) on Days 1 through 14 of each cycle (actual dose dependent upon BSA). No treatment on Days 15 through 21 of each cycle. Cycles repeated every 3 weeks
Interventions/Control_2	S-1: target dose of 80 mg/m2/day (orally) on Days 1 through 28 of each cycle (actual dose dependent upon BSA). No treatment on Days 29 through 42 of each cycle. Cycles repeated every 6 weeks
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	79 years-old >
Gender	Male and Female
Key inclusion criteria	1.Age 20-79 years. 2.Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma. 3.Subjects must be able to take orally. 4.Measurable lesion and/or non-measurable lesion defined by RECIST. 5.ECOG performance status ≤ 1 6.Hgb ≥ 8 g/dL, WBC 4000-12,000/mm3 platelets ≥100,000/mm3 7.Creatinine ≤ upper normal limit (UNL) 8.Total bilirubin ≤ 1.5 X UNL 9.AST (SGOT) and ALT (SGPT) ≤ 2.5 X UNL 10.Alkaline phosphastase ≤ 2.5 X UNL 11.Subjects must have fully recovered from surgical damage 12.No prior chemotherapy, however the following prior chemotherapy treatments are allowed: Prior adjuvant (or neo-adjuvant) chemotherapy: Subjects must have elapsed 6 months or more after the end of treatment, and must have fully recovered from acute toxicities of the previous treatment. 13.Life expectancy estimated more than 3 months. 14.Written informed consent
Key exclusion criteria	1.Active double cancer (except early stage colorectal cancer) 2.Gastrointestinal bleeding. 3.Excessive amounts of ascites require drainage. 4.Known brain metastases. 5.Symptomatic peripheral neuropathy ≥ grade 2. by NCI-CTCAE ver.3.0 6.Pulmonary fibrosis, Interstitial pneumonitis. 7.History of hypersensitivity to fluoropyrimidines, docetaxel, or medications formulated with polysorbate 80. 8.Any previous chemotherapy or radiotherapy for AGC. 9.Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant. 10.Treatment with any investigational product during the last 4 weeks prior to study entry. 11.Definite contraindications for the use of corticosteroids. 12.Any subject judged by the investigator to be unfit for any reason to participate in the study
Target sample size	628

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masashi Fujii
Organization	Surugadai Nihon University Hospital
Division name	Devision of Digestive Surgery
Zip code
Address	1-8-13, Kandasurugadai, Chiyoda-ku, Tokyo
TEL	03-3293-1711
Email

Public contact
Name of contact person	1st name Middle name Last name Toshifusa Nakajima
Organization	Japan Clinical Cancer Research Organization
Division name	Chief Director
Zip code
Address	3-10-6, Ariake, Kotoku, Tokyo
TEL	03-3570-0437
Homepage URL
Email	jaccro@jfcr.or.jp

Sponsor
Institute	Japan Clinical Cancer Research Organization
Institute
Department

Funding Source
Organization	Japan Clinical Cancer Research Organization
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Korean Cancer Study Group
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	2005 Year 11 Month 01 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	2005 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date	2005 Year 10 Month 01 Day
Last follow-up date	2010 Year 09 Month 01 Day
Date of closure to data entry	2010 Year 10 Month 01 Day
Date trial data considered complete	2010 Year 10 Month 01 Day
Date analysis concluded	2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 09 Month 29 Day
Last modified on	2008 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000317

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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