Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer
NCT ID: NCT03263741
Last Updated: 2019-07-08
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
20 participants
INTERVENTIONAL
2017-04-01
2020-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Paclitaxel + S-1 + Oxaliplatin group
Paclitaxel: 135 mg/m2, iv, 3h, at D1 ; S-1: 40mg twice daily for patients with a body surface area (BSA) \< 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to \< 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week; Oxaliplatin: 85 mg/m2, iv, 2h, at D1.
Paclitaxel + S-1 + Oxaliplatin
Paclitaxel: 135 mg/m2, iv, 3h, at D1. S-1: S-1: 40mg twice daily for patients with a body surface area (BSA) \< 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to \< 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week.
Oxaliplatin: 85 mg/m2, iv, 2h, at D1.
Interventions
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Paclitaxel + S-1 + Oxaliplatin
Paclitaxel: 135 mg/m2, iv, 3h, at D1. S-1: S-1: 40mg twice daily for patients with a body surface area (BSA) \< 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to \< 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week.
Oxaliplatin: 85 mg/m2, iv, 2h, at D1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Locally advanced, or recurrent, or metastasis disease；
3. Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed;
4. Life expectancy of at least 3 months;
5. ECOG score 0-1;
6. Age: 18\~70 years old;
7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC\>4.0×109/L, NEU \>1.5×109/L, PLT\>100×109/L, BIL\<1.5 times of upper limit of normal reference value, ALT and AST\<2.5 times of upper limit of normal reference value, and CRE\<1.2mg/dl;
8. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases;
9. Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver);
10. Not participating in other study projects before and during the treatment;
11. Voluntarily signed the informed consent.
Exclusion Criteria
2. Allergy to the drugs in this protocol;
3. Pregnant or lactating women;
4. Women at childbearing age and of pregnancy desire during the study.
18 Years
70 Years
ALL
No
Sponsors
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Affiliated Hospital of Qinghai University
OTHER
Responsible Party
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Jiuda Zhao
Professor
Principal Investigators
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Jiuda Zhao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Qinghai University
Locations
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Affiliated Hospital of Qinghai University
Xining, Qinghai, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AHQU-2017002
Identifier Type: -
Identifier Source: org_study_id
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