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NCT Number: NCT02725424

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

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)

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 10000, China

About this study

(HER2, human epidermal growth factor receptor-2) positive patients: After 4 cycles of SOX±Trastuzumab neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive 4 cycles of SOX±Trastuzumab adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.

(HER2, human epidermal growth factor receptor-2,HER2) negative patients： After 4 cycles of DOS or SOX regimen as neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive then 4 cycles of DOS or SOX adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Oxaliplatin

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.

Other names: Oxaliplatin, S-1

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.

Other names: S-1

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

Other names: Oxaliplatin, S-1

Primary outcomes

  1. major Pathological response rate

    Time frame: 40 months

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

A Randomized, Controlled Phase II Study to Compare Preoperative Chemotherapies in Locally Advanced Gastric/Gastroesophageal Cancer

Acronym: MATCH

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Apr 1, 2016
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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