Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Unknown
Verified April 2016 by Aiping Zhou, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : April 1, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Aiping Zhou, Chinese Academy of Medical Sciences

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: 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:

(human epidermal growth factor receptor-2,HER2) positive patients: After 4 weeks of SOX±Trastuzumab Neoadjuvant therapy, those who show CR(complete response) or PR(partial response) by Resist evaluation will continue with D2 surgery , then 4cycles of SOX±Trastuzumab Adjuvant chemotherapy, and 4cycles of Trastuzumab as maintenance therapy; those who do not response to former therapy or progress, will be treated with surgery,concurrent chemoradiotherapy,or 2th line chemotherapy.

(human epidermal growth factor receptor-2,HER2) negative patients: After 4 weeks of DOS or SOX regimen as neoadjuvant therapy, those who show CR(complete response) or PR(partial response) by Resist evaluation will continue with D2 surgery , then 4cycles of SOX adjuvant chemotherapy, those who do not response to former therapy or progress, will be treated with surgery,concurrent chemoradiotherapy,or 2th line chemotherapy.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Controlled Phase II Study to Compare Preoperative Chemotherapy Versus Chemoradiotherapy in Locally Advanced Gastric/Gastroesophageal Cancer
Study Start Date : August 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Active Comparator: Her2 Positive with SOX
Her-2 Positive patients treated with Oxaliplatin plus S-1(SOX) Oxaliplatin 130 mg/m2, iv, d1 S-1 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg/day(Body Surface Areas>1.5m2), po,Bid, d1-14 Every 3weeks
Drug: S-1
Her-2 Positive patients with SOX Oxaliplatin: 130 mg/m2, iv, d1 S-1: 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg/day(Body Surface Areas>1.5m2), po,Bid, d1-14 Every 3weeks.
Other Name: Oxaliplatin

Drug: Oxaliplatin
HER-2 Negative Patients:SOX Oxaliplatin: 130 mg/m2, iv, d1 S-1: 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg/day(Body Surface Areas>1.5m2), PO,BID, d1-14 Every 3 weeks
Other Name: S-1

Experimental: Her2 Positive with SOXT
Her-2 positive patients treated with Oxaliplatin plus S-1 and Trastuzumab Oxaliplatin : As Above S-1: As Above Trastuzumab :6 mg/kg, iv, d1 :8 mg/kg Every 3weeks
Drug: S-1
Her-2 Positive patients with SOX Oxaliplatin: 130 mg/m2, iv, d1 S-1: 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg/day(Body Surface Areas>1.5m2), po,Bid, d1-14 Every 3weeks.
Other Name: Oxaliplatin

Drug: Trastuzumab
Her-2 positive patients with SOXT Oxaliplatin: 130 mg/m2, iv, d1 S-1: 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg/day(Body Surface Areas>1.5m2), PO,BID, d1-14 Trastuzumab :6 mg/kg, iv, d1 :8 mg/kg Every 3weeks.
Other Names:
  • Oxaliplatin
  • S-1

Drug: Oxaliplatin
HER-2 Negative Patients:SOX Oxaliplatin: 130 mg/m2, iv, d1 S-1: 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg/day(Body Surface Areas>1.5m2), PO,BID, d1-14 Every 3 weeks
Other Name: S-1

Active Comparator: Her2 Negative with SOX
Her2 Negative patients treated with Oxaliplatin plus S-1(SOX) Oxaliplatin As Above S-1 As Above Every 3 weeks
Drug: S-1
Her-2 Positive patients with SOX Oxaliplatin: 130 mg/m2, iv, d1 S-1: 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg/day(Body Surface Areas>1.5m2), po,Bid, d1-14 Every 3weeks.
Other Name: Oxaliplatin

Drug: Oxaliplatin
HER-2 Negative Patients:SOX Oxaliplatin: 130 mg/m2, iv, d1 S-1: 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg/day(Body Surface Areas>1.5m2), PO,BID, d1-14 Every 3 weeks
Other Name: S-1

Experimental: Her2 Negative with DOS
Her-2 Negative patients treated with Docetaxel plus Oxaliplatin and S-1(DOS) Docetaxel 60 mg/m2, iv, d1 Oxaliplatin 100 mg/m2, iv, d1 S-1 60 mg/m2,po,Bid, d1-14 Every 3 weeks
Drug: S-1
Her-2 Positive patients with SOX Oxaliplatin: 130 mg/m2, iv, d1 S-1: 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg/day(Body Surface Areas>1.5m2), po,Bid, d1-14 Every 3weeks.
Other Name: Oxaliplatin

Drug: Oxaliplatin
HER-2 Negative Patients:SOX Oxaliplatin: 130 mg/m2, iv, d1 S-1: 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg/day(Body Surface Areas>1.5m2), PO,BID, d1-14 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 60 mg/m2,po,Bid, d1-14 Every 3 weeks
Other Names:
  • Oxaliplatin
  • S-1




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (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. Significant HER-2 status:

    positive defined as: immunohistochemistry+ + + or FISH(fluorescence in situ hybridization) +. T negative define as: immunohistochemistry 0 ~ +, or immunohistochemistry++, and FISH negative.

  3. T3-4, any N stage of gastric cancer or gastro esophageal carcinoma (seventh edition of AJCC).
  4. Chemotherapy and radiotherapy naïve.
  5. Aging from 18-70.
  6. ECOG(Eastern Cooperative Oncology Group ) 0-1
  7. Available Organ function: Neutrophils>2g/L, Hemoglobin >9g/L, Blood platelet >100g/L; Alanine aminotransferase(ALT) and Aspartate aminotransferase( AST) <1.5 ULN(upper limit of normal ); Total bilirubin(TBIL)<1.0 ULN; Cr <1.0 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

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


Contacts
Layout table for location contacts
Contact: Ping Ai Zhou, Phd 13691161998
Contact: Qi Xue, PHD 13801204967 xueqi02@139.com

Locations
Layout table for location information
China, Beijing
Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 10000
Contact: Ping Ai Zhou, PHD    13691161998    zhouap1825@126.com   
Contact: liang Zhao, PHD    18611110507    drzhaoliang@126.com   
Principal Investigator: Ping Ai Zhou, PHD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: Ping Ai Ping, PHD Chinese Academy of Medical Sciences

Layout table for additonal information
Responsible Party: Aiping Zhou, Chief physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02725424     History of Changes
Other Study ID Numbers: CH-GI-071
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
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