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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02725424
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : August 17, 2022
Sponsor:
Information provided by (Responsible Party):
Aiping Zhou, Chinese Academy of Medical Sciences

Study Description
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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)


Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: S-1 Drug: Trastuzumab Drug: Oxaliplatin Drug: Docetaxel Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Phase II Study to Compare Preoperative Chemotherapies in Locally Advanced Gastric/Gastroesophageal Cancer
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Her2 Positive with SOX
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
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 Name: Oxaliplatin

Drug: Oxaliplatin
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 Name: S-1
Experimental: Her2 Positive with SOXT
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
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 Name: Oxaliplatin

Drug: Trastuzumab
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

Drug: Oxaliplatin
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 Name: S-1
Active Comparator: Her2 Negative with SOX
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
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 Name: Oxaliplatin

Drug: Oxaliplatin
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 Name: S-1
Experimental: Her2 Negative with DOS
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
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 Name: Oxaliplatin

Drug: Oxaliplatin
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 Name: S-1

Drug: Docetaxel
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


Outcome Measures
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Primary Outcome Measures :
  1. major Pathological response rate [ Time Frame: 40 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725424


Locations
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China, Beijing
Chinese Academy of Medical Sciences
Beijing, Beijing, China, 10000
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Ping Ai Zhou, MD Chinese Academy of Medical Sciences
More Information
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Responsible Party: Aiping Zhou, Chief physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02725424    
Other Study ID Numbers: CH-GI-071
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
 Oxaliplatin
Trastuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological