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

• ClinicalTrials.gov Identifier: NCT02725424
• Recruitment Status: Completed
• First Posted: April 1, 2016
• Last Update Posted: August 17, 2022
• Sponsor: Chinese Academy of Medical Sciences
• Information provided by (Responsible Party): Aiping Zhou, Chinese Academy of Medical Sciences

Tracking Information

• First Submitted Date: March 11, 2016
• First Posted Date: April 1, 2016
• Last Update Posted Date: August 17, 2022
• Actual Study Start Date: August 2015
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 14, 2022): major Pathological response rate [ Time Frame: 40 months ]
• Original Primary Outcome Measures (submitted: March 28, 2016): Pathological response rate [ Time Frame: 40 months ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Optimizing the Strategy for Preoperative Chemotherapy in Locally Advanced Gastric/Gastroesophageal Cancer
• Official Title: A Randomized, Controlled Phase II Study to Compare Preoperative Chemotherapies in Locally Advanced Gastric/Gastroesophageal Cancer

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Cancer

Intervention

• 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
• 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

Study Arms

• 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.
  Interventions:

  • Drug: S-1
  • Drug: Oxaliplatin
• 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.
  Interventions:

  • Drug: S-1
  • Drug: Trastuzumab
  • Drug: Oxaliplatin
• 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.
  Interventions:

  • Drug: S-1
  • Drug: Oxaliplatin
• 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.
  Interventions:

  • Drug: S-1
  • Drug: Oxaliplatin
  • Drug: Docetaxel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 14, 2022): 180
• Original Estimated Enrollment (submitted: March 28, 2016): 414
• Actual Study Completion Date: June 2019
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02725424
• Other Study ID Numbers: CH-GI-071
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Aiping Zhou, Chinese Academy of Medical Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Chinese Academy of Medical Sciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ping Ai Zhou, MD; Chinese Academy of Medical Sciences

• PRS Account: ChineseAMS
• Verification Date: August 2022