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Trial record 6 of 2006 for:    oxaliplatin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03263741
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jiuda Zhao, Affiliated Hospital of Qinghai University

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Paclitaxel + S-1 + Oxaliplatin Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: 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.
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.

Other Name: Paclitaxel + S-1 + Oxaliplatin chemotherapy




Primary Outcome Measures :
  1. Objective response rate(ORR) [ Time Frame: 2 years ]
    The sum of complete remission (CR) rate and partial remission (PR) rate.


Secondary Outcome Measures :
  1. Progression-free survival(PFS) [ Time Frame: 2 years ]
    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. Overall survival(OS) [ Time Frame: 2 years ]
    From date of enrollment until the date of death from any cause, assessed up to 60 months

  3. Disease control rate(DCR) [ Time Frame: 2 years ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263741


Contacts
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Contact: Jiuda Zhao, M.D. +8613327661976 jiudazhao@126.com

Locations
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China, Qinghai
Affiliated Hospital of Qinghai University Recruiting
Xining, Qinghai, China, 810000
Contact: Jiuda Zhao, M.D.    +8613327661976    jiudazhao@126.com   
Contact: Dengfeng Ren, M.D.    +8613086297659    dengfeng1104@126.com   
Sponsors and Collaborators
Affiliated Hospital of Qinghai University
Investigators
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Principal Investigator: Jiuda Zhao, M.D. Affiliated Hospital of Qinghai University

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Responsible Party: Jiuda Zhao, Professor, Affiliated Hospital of Qinghai University
ClinicalTrials.gov Identifier: NCT03263741    
Other Study ID Numbers: AHQU-2017002
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiuda Zhao, Affiliated Hospital of Qinghai University:
Paclitaxel
S-1
Oxaliplatin
Efficiency
safety
Additional relevant MeSH terms:
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Oxaliplatin
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action