Neoadjuvant SLOT Versus SOX in Patients With Locally Advanced, Resectable Gastric/Esophagogastric Junction (EGJ) Cancer

August 6, 2015 updated by: Jing Huang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Neoadjuvant S1, Oxaliplatin, and Docetaxel (SLOT) Versus S1, Oxaliplatin(SOX) in Patients With Locally Advanced, Resectable Gastric/Esophagogastric Junction (EGJ) Cancer

gastric cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the 5-year survival of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Two arms, phase 3 study of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer. 380 Patients will be enrolled in this trial. The primary objective of this study is to determine the 5-year survival of the two arms.

Study Type

Interventional

Enrollment (Anticipated)

380

Phase

  • Phase 3

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
      • Beijing, China, 100021
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven gastric or GE junction adenocarcinoma;
  • Age: 18 to 70;
  • ECOG 0-2;
  • Adenocarcinoma of the stomach or GE junction according to staging classification TNM Scannographic: T3-4 N0/N + M0 ;
  • Completion of baseline quality of life questionnaire
  • Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl);
  • Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
  • liver functions (serum bilirubin ≤ 1.5UNL, AST/ALT ≤ 3 times(normal value)
  • Written informed consent

Exclusion Criteria:

  • Previous chemotherapy;
  • Active infection requiring antibiotics
  • Pregnant, lactating women
  • Psychiatric illness, epileptic disorders
  • Concurrent systemic illness not appropriate for chemotherapy
  • History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SLOT group
4 cycles preoperative chemotherapy with Docetaxel+oxaliplatin+s1 . Gastric resection. 6 cycles adjuvant chemotherapy with sequential oxaliplatin+s1 or oxaliplatin+s1,then s1 for 6 months。
Drug: Docetaxel;oxaliplatin;s1
Docetaxel 60mg/m2 was administered on day 1 of every 14 days.oxaliplatin 85 mg/m2 was administered on day 2 every 14 days. 40-60 mg of oral S-1 according to body-surface area twice a day was given for 10 days every 14 days .
Active Comparator: SOX group
3 cycles preoperative chemotherapy with oxaliplatin+s1. Gastric resection. 4 cycles adjuvant chemotherapy with sequential oxaliplatin+s1
Drug: oxaliplatin;s1
oxaliplatin 100 mg/m2 on day 1 every 21 days.40-60 mg of oral S-1 according to body-surface area twice a day was given for 2 weeks every 21 days .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
5 year overall survival
Time Frame: 6 years
6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
3 year relapse free survival
Time Frame: 5 years
5 years
Surgical complete resection rate (R0)
Time Frame: 2.5 year
2.5 year
Pathological response rate
Time Frame: 2.5 year
2.5 year

Other Outcome Measures

Outcome Measure
Time Frame
quality of life questionnaire
Time Frame: 6 year
6 year

Collaborators and Investigators

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Chair: Jing Huang, M.D., Cancer hospital, CAMS

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

July 1, 2015

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-GI-069

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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