Study on Neoadjuvant Chemotherapy for Advanced Gastric Cancer

June 11, 2014 updated by: Jiafu Ji, Peking University

Phase II Study of Paclitaxel Liposome Plus S-1 as Neoadjuvant Chemotherapy for Advanced Gastric Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Haidian District, Beijing, China, 100142
        • Peking University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 weeks
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.
up to 24 weeks
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.
up to 12 weeks
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 .
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

June 7, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

June 11, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPS-01-2013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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