UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000251 |
|---|---|
| Receipt number | 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 08:15:55 |
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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
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
jaccro@jfcr.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000317
