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T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric Cancer, HER2-positive, Trastuzumab, XELOX, Stage III, D2 Gastrectomy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Trastuzumab
Type: Drug
Name: Capecitabine
Type: Drug
Name: Oxaliplatin
Type: Drug
Overall Status
Recruiting
Summary
The objective of this study is to assess the clinical efficacy and safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.
Detailed Description
Gastric cancer is the second leading cause of cancer death worldwide. Highest incidence rate is observed in Eastern Asia.
D2 gastrectomy has been established as a standard surgical procedure. While recurrence rate after resection is still high.
The CLASSIC study showed that Xelox regimen after D2 gastrectomy improves 3-year disease-free survival compared with surgery only. But patients with late stage still have poor prognosis according to subgroup analysis and our retrospective study.
HER2 is an important biomarker and key driver of tumorigenesis in 7-34% gastric cancers. The ToGA study showed that trastuzumab, a monoclonal antibody that targets HER2, plus chemotherapy improved overall survival(16.0m vs 11.8m) in patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer.
Based on previous experiences of trastuzumab in adjunctive therapy of breast cancer and ACTS/CLASSIC/ToGA studies, we suppose that trastuzumab plus XELOX as adjunctive treatment may benefit patients with HER2-positive Stage III gastric cancer after D2 Gastrectomy.
According to the above, we do this single-arm research to assess the clinical efficacy and safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.
D2 gastrectomy has been established as a standard surgical procedure. While recurrence rate after resection is still high.
The CLASSIC study showed that Xelox regimen after D2 gastrectomy improves 3-year disease-free survival compared with surgery only. But patients with late stage still have poor prognosis according to subgroup analysis and our retrospective study.
HER2 is an important biomarker and key driver of tumorigenesis in 7-34% gastric cancers. The ToGA study showed that trastuzumab, a monoclonal antibody that targets HER2, plus chemotherapy improved overall survival(16.0m vs 11.8m) in patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer.
Based on previous experiences of trastuzumab in adjunctive therapy of breast cancer and ACTS/CLASSIC/ToGA studies, we suppose that trastuzumab plus XELOX as adjunctive treatment may benefit patients with HER2-positive Stage III gastric cancer after D2 Gastrectomy.
According to the above, we do this single-arm research to assess the clinical efficacy and safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1. Signed informed-consent form.
2. Aged 18-80 years.
3. Had partial or total D2 gastrectomy and achieved R0 resection.
4. Histologically confirmed gastric or gastro-oesophageal junction adenocarcinoma，mucinous adenocarcinoma ，signet-ring cell carcinoma
5. Pathologic Stage III (IIIA-C).
6. HER2-positive: (IHC 3+ or IHC 2+ and FISH positive).
7. Patients must have received no preoperative chemotherapy or radiation therapy.
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 .
9. Adequate liver/bone marrow function.Blood and biochemical parameters;
10. Compliant, and can be followed up regularly.
Exclusion Criteria:
1. Patients who do not meet the Inclusion Criteria.
2. Pregnant or breast-feeding female, or not willing to take contraception measures during study.
3. Serious infection requiring antibiotics intervention during recruitment.
4. Allergic to study drug or with metabolism disorder.
5. Histologically confirmed small cell carcinoma of the stomach、gastric neuroendocrine carcinoma or others.
6. Uncontrolled brain metastasis or mental illness.
7. Organ transplant recipients (Autologous transplantation of bone marrow and peripheral stem cell transplantation included).
8. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
9. With severe hepatic/kidney/respirator/disease,or chronic disease like uncontrolled diabetes,hypertension,etc.
10. with other malignant tumors.
11. Can be followed up or obey protocol.
12. Ineligible by the discretion of the investigator.
1. Signed informed-consent form.
2. Aged 18-80 years.
3. Had partial or total D2 gastrectomy and achieved R0 resection.
4. Histologically confirmed gastric or gastro-oesophageal junction adenocarcinoma，mucinous adenocarcinoma ，signet-ring cell carcinoma
5. Pathologic Stage III (IIIA-C).
6. HER2-positive: (IHC 3+ or IHC 2+ and FISH positive).
7. Patients must have received no preoperative chemotherapy or radiation therapy.
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 .
9. Adequate liver/bone marrow function.Blood and biochemical parameters;
10. Compliant, and can be followed up regularly.
Exclusion Criteria:
1. Patients who do not meet the Inclusion Criteria.
2. Pregnant or breast-feeding female, or not willing to take contraception measures during study.
3. Serious infection requiring antibiotics intervention during recruitment.
4. Allergic to study drug or with metabolism disorder.
5. Histologically confirmed small cell carcinoma of the stomach、gastric neuroendocrine carcinoma or others.
6. Uncontrolled brain metastasis or mental illness.
7. Organ transplant recipients (Autologous transplantation of bone marrow and peripheral stem cell transplantation included).
8. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
9. With severe hepatic/kidney/respirator/disease,or chronic disease like uncontrolled diabetes,hypertension,etc.
10. with other malignant tumors.
11. Can be followed up or obey protocol.
12. Ineligible by the discretion of the investigator.
Location
Chinese PLA General Hospital
Beijing, Beijing, China
Status: Recruiting
Contact: Guanghai Dai - daigh60@sohu.com
Start Date
July 2014
Completion Date
December 2017
Sponsors
Chinese PLA General Hospital
Source
Chinese PLA General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page