Back to resultsExploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paclitaxel + S-1 + Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Paclitaxel, S-1, Oxaliplatin, Efficiency, safety
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Affiliated Hospital of Qinghai UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paclitaxel + S-1 + Oxaliplatin group
Arm 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.
Outcomes
Primary Outcome Measures
Objective response rate(ORR)
The sum of complete remission (CR) rate and partial remission (PR) rate.
Secondary Outcome Measures
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
Overall survival(OS)
From date of enrollment until the date of death from any cause, assessed up to 60 months
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
Full Information
NCT ID
NCT03263741
First Posted
August 22, 2017
Last Updated
July 4, 2019
Sponsor
Affiliated Hospital of Qinghai University
1. Study Identification
Unique Protocol Identification Number
NCT03263741
Brief Title
Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Qinghai University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in the Patients with Locally Advanced or Advanced Gastric Cancer
Detailed Description
To assess the Efficiency and safety of Paclitaxel + S-1 + Oxaliplatin(PSOX) in the Patients with Locally Advanced or Advanced Gastric Cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Paclitaxel, S-1, Oxaliplatin, Efficiency, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel + S-1 + Oxaliplatin group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel + S-1 + Oxaliplatin
Other Intervention Name(s)
Paclitaxel + S-1 + Oxaliplatin chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate(ORR)
Description
The sum of complete remission (CR) rate and partial remission (PR) rate.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression-free survival(PFS)
Description
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
Time Frame
2 years
Title
Overall survival(OS)
Description
From date of enrollment until the date of death from any cause, assessed up to 60 months
Time Frame
2 years
Title
Disease control rate(DCR)
Description
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
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiuda Zhao, M.D.
Phone
+8613327661976
Email
jiudazhao@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiuda Zhao, M.D.
Organizational Affiliation
Affiliated Hospital of Qinghai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Qinghai University
City
Xining
State/Province
Qinghai
ZIP/Postal Code
810000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiuda Zhao, M.D.
Phone
+8613327661976
Email
jiudazhao@126.com
First Name & Middle Initial & Last Name & Degree
Dengfeng Ren, M.D.
Phone
+8613086297659
Email
dengfeng1104@126.com
12. IPD Sharing Statement
Learn more about this trial
Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer
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