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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: Gastric Adenocarcinoma

Treatments: Drug: Docetaxel;oxaliplatin;s1; Drug: oxaliplatin;s1

Study type: Interventional

Funder types: Other

Identifiers

NCT02512380

CH-GI-069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

SLOT group

Experimental group

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。

Treatment:

Drug: Docetaxel;oxaliplatin;s1

SOX group

Active Comparator group

Description:

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

Treatment:

Drug: oxaliplatin;s1