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UMIN-CTR Clinical Trial |
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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 |
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)
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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)
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Region |
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Condition | |||
Condition | Gastric Cancer | ||
Classification by specialty |
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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 |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 628 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 | |
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Results Delay Reason | |
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Baseline Characteristics | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |