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

Primary Purpose

Gastric Adenocarcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Docetaxel;oxaliplatin;s1
oxaliplatin;s1
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SLOT group

SOX group

Arm Description

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。

3 cycles preoperative chemotherapy with oxaliplatin+s1. Gastric resection. 4 cycles adjuvant chemotherapy with sequential oxaliplatin+s1

Outcomes

Primary Outcome Measures

5 year overall survival

Secondary Outcome Measures

3 year relapse free survival
Surgical complete resection rate (R0)
Pathological response rate

Full Information

First Posted
July 29, 2015
Last Updated
August 6, 2015
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02512380
Brief Title
Neoadjuvant SLOT Versus SOX in Patients With Locally Advanced, Resectable Gastric/Esophagogastric Junction (EGJ) Cancer
Official Title
Neoadjuvant S1, Oxaliplatin, and Docetaxel (SLOT) Versus S1, Oxaliplatin(SOX) in Patients With Locally Advanced, Resectable Gastric/Esophagogastric Junction (EGJ) Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SLOT group
Arm Type
Experimental
Arm Description
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。
Arm Title
SOX group
Arm Type
Active Comparator
Arm Description
3 cycles preoperative chemotherapy with oxaliplatin+s1. Gastric resection. 4 cycles adjuvant chemotherapy with sequential oxaliplatin+s1
Intervention Type
Drug
Intervention Name(s)
Docetaxel;oxaliplatin;s1
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
oxaliplatin;s1
Intervention Description
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 .
Primary Outcome Measure Information:
Title
5 year overall survival
Time Frame
6 years
Secondary Outcome Measure Information:
Title
3 year relapse free survival
Time Frame
5 years
Title
Surgical complete resection rate (R0)
Time Frame
2.5 year
Title
Pathological response rate
Time Frame
2.5 year
Other Pre-specified Outcome Measures:
Title
quality of life questionnaire
Time Frame
6 year

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Huang, M.D.
Phone
8610-87788103
Email
huangjingwg@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Huang, M.D
Phone
8610-87788103
Email
huangjingwg@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Huang, M.D.
Organizational Affiliation
Cancer Hospital, CAMS
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Wang, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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