To hear about similar clinical trials, please enter your email below
Trial Title:
T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy
NCT ID:
NCT02250209
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Capecitabine
Oxaliplatin
Trastuzumab
Conditions: Keywords:
Gastric Cancer
HER2-positive
Trastuzumab
XELOX
Stage III
D2 Gastrectomy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
Trastuzumab is given by intravenous infusion at 440mg on day 0every 3 weeks. Number of
cycles: 14~16 cycles.
Arm group label:
Trastuzumab,Capecitabine,Oxaliplatin
Other name:
Herceptin
Other name:
Herclon
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine 800~1000 mg/m² is given orally twice a day for 14 days followed by a 1-week
rest.
Number of cycles: 8 cycles.
Arm group label:
Trastuzumab,Capecitabine,Oxaliplatin
Other name:
Xeloda
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin is given by intravenous infusion at 130 mg/m2 on day 1 every 3 weeks.
Number of cycles: 8 cycles.
Arm group label:
Trastuzumab,Capecitabine,Oxaliplatin
Other name:
Eloxatin
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Guanghai Dai
Email:
daigh60@sohu.com
Contact backup:
Last name:
Yan Shi
Phone:
13810561979
Email:
shibaiwan12@sina.com
Investigator:
Last name:
Guanghai Dai
Email:
Principal Investigator
Start date:
July 2014
Completion date:
December 2017
Lead sponsor:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02250209
