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

Gastric Cancer Clinical Trial

Official title:

Exploratory Study on the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin Chemotherapy in the Patients With Locally Advanced or Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03263741
• Other study ID #: AHQU-2017002
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2017
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2019
• Source: Affiliated Hospital of Qinghai University
• Contact: Jiuda Zhao, M.D.
• Phone: +8613327661976
• Email: jiudazhao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Affiliated Hospital of Qinghai University	Xining	Qinghai

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Qinghai University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate(ORR)	The sum of complete remission (CR) rate and partial remission (PR) rate.	2 years
Secondary	Progression-free survival(PFS)	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months	2 years
Secondary	Overall survival(OS)	From date of enrollment until the date of death from any cause, assessed up to 60 months	2 years
Secondary	Disease control rate(DCR)	The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year	2 years