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

NCT ID: NCT02512380

Last Updated: 2015-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2021-07-31

Brief Summary

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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

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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.

Conditions

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Gastric Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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。

Group Type EXPERIMENTAL

Docetaxel;oxaliplatin;s1

Intervention Type 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 .

SOX group

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

Group Type ACTIVE_COMPARATOR

oxaliplatin;s1

Intervention Type 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 .

Interventions

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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 .

Intervention Type 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 .

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Jing Huang

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jing Huang, M.D.

Role: STUDY_CHAIR

Cancer Hospital, CAMS

Locations

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Huang, M.D.

Role: CONTACT

8610-87788103

Jing Huang, M.D

Role: CONTACT

8610-87788103

Facility Contacts

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Xi Wang, M.D

Role: primary

Other Identifiers

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CH-GI-069

Identifier Type: -

Identifier Source: org_study_id

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