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Study on Neoadjuvant Chemotherapy for 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163291
Recruitment Status : Unknown
Verified June 2014 by Jiafu Ji, Peking University.
Recruitment status was:  Not yet recruiting
First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
Jiafu Ji, Peking University

Brief Summary:
Gastric cancer is the second cause of cancer related death and China has the most gastric cancer patients in the world. Although systemic strategies, including adjuvant chemotherapy, postoperative chemoradiotherapy, perioperative chemotherapy, have evolved and showed benefits these years, the prognosis of advanced gastric cancer is still not satisfactory. Optimal regimens and optimal method administration is still being found. Neoadjuvant chemotherapy has many advantages, including downstaging the tumor, increasing R0 rate, early eradicating of micrometastasis. In previous trials, combination of paclitaxel and s-1 has showed safety and tolerance in recurrent or metastatic gastric cancer. Using liposome as a carrier, paclitaxel has a better histocompatibility and cellular affinity, resulting a improved stability and reduced toxicity. In this phase II trial, we are going to study the safety and feasibility of paclitaxel liposome plus s-1 as neoadjuvant chemotherapy.

Condition or disease Intervention/treatment Phase
Advanced Gastric Carcinoma Drug: paclitaxel liposome Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Paclitaxel Liposome Plus S-1 as Neoadjuvant Chemotherapy for Advanced Gastric Cancer
Study Start Date : December 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: paclitaxel liposome
S-1 plus paclitaxel liposome
Drug: paclitaxel liposome
S-1 40 mg/m2 bid d1-14 po and paclitaxel liposome 175mg/m2 d1 intravenously infusion for 3 hours, every 3 weeks. After 2 cycles' treatment, if clinical response is complete response(CR),partial regression(PR) or stable disease(SD), another 2 cycles is administered and operation is performed after the total 4 cycles. If response is progressive disease(PD), chemotherapy is stopped and operation is performed.




Primary Outcome Measures :
  1. Pathological complete response rate [ Time Frame: up to 24 weeks ]
    Pathology is usually reported 1 week after operation.The result of Pathological complete response rate will be accessed after all of the 30 participants operated.


Secondary Outcome Measures :
  1. Object Response Rate [ Time Frame: up to 24 weeks ]
    Object Response Rate(ORR) is defined as the percentage of CR and PR among all of the participants under best overall outcome evaluation .Pathology is usually reported 1 week after operation.The result of Object Response Rate will be accessed after all of the 30 participants operated.

  2. Disease Control Rate [ Time Frame: up to 24 weeks ]
    Disease Control Rate(DC R) is defined as the percentage of CR+PR+SD among all of the participants under best overall outcome evaluation .Pathology is usually reported 1 week after operation.The result of Disease Control Rate will be accessed after all of the 30 participants operated.

  3. Number of Participants with Adverse Eventss a Measure of Safety and Tolerability [ Time Frame: up to 12 weeks ]
    Participants will be followed during all the s a Measure of Safety and Tolerability4 circles of chemotherapy ,an expected average of 12 weeks.Number of participants with Adverse Events will calculated as a Measure of Safety and Tolerability.

  4. R0 rate, surgical morbidity and mortality [ Time Frame: 2 weeks ]
    The results of R0 rate, surgical morbidity and mortality will be accessed after operation ,participants will be followed for the duration of hospital stay, an expected average of 2 weeks .



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed gastric cancer
  • Disease at clinical stage of resectable or potentially resectable(T3-4, N0-3, M0) by CT and endoscopic ultrasonography (EUS)
  • Karnofsky performance status(KPS) ≥ 70
  • No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
  • Life expectancy more than 3 months
  • Adequate organ function as defined below:White Blood Cell Count (WBC) ≥ 3.0*10^9/l, Absolute Neutrophil Count (ANC) ≥ 1.5*10^9/l, Hemoglobin ≥ 100 g/l, Platelets ≥ 100*10^9/l, Total Bilirubin (TBIL) ≤ 1.5mg/dl, Aspartate Aminotransferase(AST) and Alanine Aminotransferase(ALT) ≤ 2.5×ULN, Alkaline pPosphatase( ALP) ≤ 2.5×ULN, Renal Serum Creatinine < 1.5mg/dl
  • Adequate lung and heart function

Exclusion Criteria:

  • ≥ grade 2 neuropathy
  • History of malignancy
  • With uncontrolled central nervous system metastasis
  • Concurrent disease or condition that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, acute infection, severe malnutrition, uncontrolled diabetes hypertension et al)
  • Severely inadequate intake of water or diet

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): NCT02163291


Contacts
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Contact: Jiafu Ji, M.D. jiafuj@hotmail.com

Locations
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China
Peking University Cancer Hospital
Haidian District, Beijing, China, 100142
Contact: Ziyu Li, M.D.       ligregory369@hotmail.com   
Contact: Zhaodong Xing, M.D.       xingzhaodong2011@sina.com   
Principal Investigator: Jiafu Ji, M.D.         
Sub-Investigator: Ziyu Li, M.D.         
Sub-Investigator: Kan Xue, M.D.         
Sub-Investigator: Zhaodong Xing, MD         
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Jiafu Ji, M.D. Beijing Cancer Hospital
Additional Information:
Publications:

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Responsible Party: Jiafu Ji, President, Peking University
ClinicalTrials.gov Identifier: NCT02163291    
Other Study ID Numbers: LPS-01-2013
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: June 13, 2014
Last Verified: June 2014
Keywords provided by Jiafu Ji, Peking University:
advanced gastric cancer
neoadjuvant chemotherapy
safety
feasibility
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action