Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer
NCT ID: NCT01747707
Last Updated: 2012-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2012-09-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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docetaxel, cisplatin and S-1 (DCS)
All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2.
Docetaxel
Cisplatin
S-1
Interventions
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Docetaxel
Cisplatin
S-1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No previous chemotherapy and radiation for advanced disease except palliative radiation for a local pain control;
* At least one evaluable lesion per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
* ECOG (Eastern Cooperative Oncology Group) performance status 0-1;
* Recovery from the toxicities of previous therapy;
* Adequate bone marrow and organ function. Hb≥8 G/L; Absolute neutrophil ≥ 2.0 G/L; PLT ≥100 G/L ;ALT/AST ≤1.5 ULN or ≤5ULN with liver metastases; TBIL ≤1.5 ULN; Cr≤1.0 ULN;
* Life expectancy ≥3 months;
* For men and women of childbearing potential, agree on taking effective contraceptive method of birth control from the signed informed consent until 3 months after the last study drug administration;
* Signed informed consent.
Exclusion Criteria
* Previous treatment with taxanes, cisplatin or S-1;
* Relapse within 6 months after the end of adjuvant chemotherapy;
* Known brain metastases;
* Complete or incomplete intestinal obstruction or uncontrolled gastrointestinal bleeding;
* Known deficiency of DPD enzyme;
* Kown HIV infecton or drug addiction;
* Any acute or chronic medical or psychiatric condition that would make the patient inappropriate for entry into this trial in the judgement of investigators;
* Myocardial infarction within 6 months prior to the entry of this trial;
* Known history of allergic reaction to taxanes and platinum;
* Pregnant or breast feeding women.
18 Years
75 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Aiping Zhou
Associate professor
Principal Investigators
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Aiping Zhou, M.D
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Locations
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Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Yongkun Sun, M.D
Role: primary
Other Identifiers
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CH-GI-31
Identifier Type: -
Identifier Source: org_study_id