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

NCT02512380 | Unknown Phase 3 DMC

• 1 other identifier: CH-GI-069
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 5 year overall survival

  6 years

Secondary Outcomes (3)

• 3 year relapse free survival

  5 years

• Surgical complete resection rate (R0)

  2.5 year

• Pathological response rate

  2.5 year

Other Outcomes (1)

• quality of life questionnaire

  6 year

Study Arms (2)

SLOT group

EXPERIMENTAL

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

SOX group

ACTIVE COMPARATOR

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

Drug: oxaliplatin;s1

Interventions

Docetaxel;oxaliplatin;s1 DRUG

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 .

SLOT group

oxaliplatin;s1 DRUG

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 .

SOX group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

Study Officials

• Jing Huang, M.D.

  Cancer Hospital, CAMS

  STUDY CHAIR

Central Study Contacts

Jing Huang, M.D.

CONTACT

8610-87788103; huangjingwg@163.com

Jing Huang, M.D

CONTACT

8610-87788103; huangjingwg@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 30, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2021
• Last Updated: August 10, 2015

Record last verified: 2015-07

Locations

CN (1)