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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-1
Trastuzumab
Oxaliplatin
Docetaxel
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Pathologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma;

  2. 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.
  3. T3-4, any N stage, M0 of gastric or gastro-esophageal junction adenocarcinoma;
  4. Chemotherapy and radiotherapy naïve.
  5. Age ≥18 years;
  6. ECOG(Eastern Cooperative Oncology Group ) 0-1;
  7. 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;
  8. Left ventricular ejection fraction>50%
  9. Written informed consent.

Exclusion criteria:

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

Sites / Locations

  • Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Her2 Positive with SOX

Her2 Positive with SOXT

Her2 Negative with SOX

Her2 Negative with DOS

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

major Pathological response rate

Secondary Outcome Measures

Full Information

First Posted
March 11, 2016
Last Updated
August 14, 2022
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02725424
Brief Title
Optimizing the Strategy for Preoperative Chemotherapy in Locally Advanced Gastric/Gastroesophageal Cancer
Acronym
MATCH
Official Title
A Randomized, Controlled Phase II Study to Compare Preoperative Chemotherapies in Locally Advanced Gastric/Gastroesophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)
Detailed Description
(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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Her2 Positive with SOX
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Her2 Positive with SOXT
Arm Type
Experimental
Arm Description
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.
Arm Title
Her2 Negative with SOX
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Her2 Negative with DOS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
Oxaliplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Oxaliplatin, S-1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
S-1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Oxaliplatin, S-1
Intervention Description
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
Primary Outcome Measure Information:
Title
major Pathological response rate
Time Frame
40 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Ai Zhou, MD
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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