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

Gastric Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02512380
• Other study ID #: CH-GI-069
• Status: Recruiting
• Phase: Phase 3
• First received: July 29, 2015
• Last updated: August 6, 2015
• Start date: July 2015
• Est. completion date: July 2021

Study information

• Verified date: July 2015
• Source: Chinese Academy of Medical Sciences
• Contact: Jing Huang, M.D.
• Phone: 8610-87788103
• Email: huangjingwg[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: July 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

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 .
• 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 .

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quality of life questionnaire		6 year	No
Primary	5 year overall survival		6 years	Yes
Secondary	3 year relapse free survival		5 years	No
Secondary	Surgical complete resection rate (R0)		2.5 year	No
Secondary	Pathological response rate		2.5 year	No