Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer

Affiliated Hospital of Qinghai University

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Paclitaxel + S-1 + Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03263741

AHQU-2017002

Details and patient eligibility

About

Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in the Patients with Locally Advanced or Advanced Gastric Cancer

Full description

To assess the Efficiency and safety of Paclitaxel + S-1 + Oxaliplatin(PSOX) in the Patients with Locally Advanced or Advanced Gastric Cancer

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
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

1. Previously treated with first-line chemotherapy;
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Paclitaxel + S-1 + Oxaliplatin group

Experimental group

Description:

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.

Treatment:

Drug: Paclitaxel + S-1 + Oxaliplatin