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

Gastric Cancer Clinical Trial

— MATCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725424
• Other study ID #: CH-GI-071
• Status: Completed
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: June 2019

Study information

• Verified date: August 2022
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

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.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major Pathological response rate		40 months