UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000251
Receipt No. R000000317
Scientific Title A Phase III Study of Docetaxel and S-1 versus S-1 in the Treatment of Advanced Gastric Cancer
Date of disclosure of the study information 2005/11/01
Last modified on 2008/10/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.