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

NCT03263741 | Unknown Phase 2

• 1 other identifier: AHQU-2017002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer

Keywords

Paclitaxel; S-1; Oxaliplatin; Efficiency; safety

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR)

  The sum of complete remission (CR) rate and partial remission (PR) rate.

  2 years

Secondary Outcomes (3)

• Progression-free survival(PFS)

  2 years

• Overall survival(OS)

  2 years

• Disease control rate(DCR)

  2 years

Study Arms (1)

Paclitaxel + S-1 + Oxaliplatin group

EXPERIMENTAL

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.

Drug: Paclitaxel + S-1 + Oxaliplatin

Interventions

Paclitaxel + S-1 + Oxaliplatin DRUG

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.

Also known as: Paclitaxel + S-1 + Oxaliplatin chemotherapy

Paclitaxel + S-1 + Oxaliplatin group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
• Locally advanced, or recurrent, or metastasis disease；
• Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed;
• Life expectancy of at least 3 months;
• ECOG score 0-1;
• Age: 18\~70 years old;
• 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;
• Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases;
• Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver);
• Not participating in other study projects before and during the treatment;
• Voluntarily signed the informed consent.

You may not qualify if:

• Previously treated with first-line chemotherapy;
• Allergy to the drugs in this protocol;
• Pregnant or lactating women;
• Women at childbearing age and of pregnancy desire during the study.

Sponsors & Collaborators

• Affiliated Hospital of Qinghai University: lead

Study Sites (1)

Affiliated Hospital of Qinghai University

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel; S 1 (combination); Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Jiuda Zhao, M.D.

  Affiliated Hospital of Qinghai University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiuda Zhao, M.D.

CONTACT

+8613327661976; jiudazhao@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 28, 2017
• Study Start: April 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2020
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

CN (1)