Optimizing the Strategy for Preoperative Chemotherapy in Locally Advanced Gastric/Gastroesophageal Cancer

NCT02725424 | Completed Phase 2 DMC

• 1 other identifier: CH-GI-071
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, phase II, open-label study. The purpose of this study is to determine the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer according to their HER-2 expression status. The primary endpoint of this study: major pathology response rate the second endpoints of this study: pathology complete response rate R0 resection rate Progression-free survival ( PFS) Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse event(AE)

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• major Pathological response rate

  40 months

Study Arms (4)

Her2 Positive with SOX

ACTIVE COMPARATOR

Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.

Drug: S-1; Drug: Oxaliplatin

Her2 Positive with SOXT

EXPERIMENTAL

Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks.

Drug: S-1; Drug: Trastuzumab; Drug: Oxaliplatin

Her2 Negative with SOX

ACTIVE COMPARATOR

Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.

Drug: S-1; Drug: Oxaliplatin

Her2 Negative with DOS

EXPERIMENTAL

Docetaxel 60 mg/m2, ivgtt, d1; Oxaliplatin 100 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) , 100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.

Drug: S-1; Drug: Oxaliplatin; Drug: Docetaxel

Interventions

S-1 DRUG

Her-2 Positive patients with SOX Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks.

Also known as: Oxaliplatin

Her2 Negative with DOS; Her2 Negative with SOX; Her2 Positive with SOX; Her2 Positive with SOXT

Trastuzumab DRUG

Her-2 positive patients with SOXT Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Trastuzumab: 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1 Every 3 weeks.

Also known as: Oxaliplatin, S-1

Her2 Positive with SOXT

Oxaliplatin DRUG

Her-2 Positive patients with SOX Oxaliplatin：130 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks.

Also known as: S-1

Her2 Negative with DOS; Her2 Negative with SOX; Her2 Positive with SOX; Her2 Positive with SOXT

Docetaxel DRUG

Her-2 Negative patients with DOS Docetaxel： 60 mg/m2, iv, d1 Oxaliplatin：100 mg/m2, iv, d1 S-1：twice a day depending on BSA po from d1-14, 80mg(BSA \<1.25m2) , 100mg(BSA ≥1.25m2, \<1.5 m2), 120 mg(BSA≥ 1.5m2), Every 3 weeks

Also known as: Oxaliplatin, S-1

Her2 Negative with DOS

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma;
• The HER2 receptor protein status should be assessed using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH);
• HER2 positive: IHC 3+ or IHC 2+/ FISH amplification.
• HER2 negative: IHC 0, 1+ or IHC 2+/ FISH without amplification.
• T3-4, any N stage, M0 of gastric or gastro-esophageal junction adenocarcinoma;
• Chemotherapy and radiotherapy naïve.
• Age ≥18 years;
• ECOG(Eastern Cooperative Oncology Group ) 0-1;
• Adequate hematological, hepatic and renal functions: absolute neutrophil count (ANC) ≥ 2.0 G/L, hemoglobin ≥ 90g/L, platelet ≥ 100 G/L; ALT and AST \<1.5 times x upper limit of normal (ULN)；serum total bilirubin \< 1.0 x ULN; serum creatinine \< 1.0 x ULN;
• Left ventricular ejection fraction\>50%
• Written informed consent.

You may not qualify if:

• Other pathology Type Other than adenocarcinoma, such as squamous cell carcinoma
• History of allergies to drugs in the study
• Intraperitoneal dissemination or distant metastasis
• Digestive tract obstruction or uncontrollable recurrent bleeding ,clinical significant ascites
• Dysphagia
• Any cause of cirrhosis
• Cardiac function NYHA(New York Heart Association) \>I degrees
• Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia
• Any surgical contraindication
• Any chemotherapy or radiotherapy history
• Any surgical resection history of gastric cancer
• History of any other tumors except cured cutaneum carcinoma or carcinoma in situs of cervix
• Any contraindication for chemotherapy

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 10000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); Oxaliplatin; Trastuzumab; Docetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Ping Ai Zhou, MD

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: April 1, 2016
• Study Start: August 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

CN (1)