Clinical trial NCT02250209: T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy
Official title: Trastuzumab Plus XELOX for HER2-positive Stage III Gastric Cancer After D2 Gastrectomy：Prospective Observational Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Gastric Cancer
HER2-positive
Trastuzumab
XELOX
Stage III
D2 Gastrectomy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: 3-year disease-free survival (DFS)
timeFrame: Measure at every 6 weeks (every 2 cycles)
Secondary outcomes:
measure: Overall survival
timeFrame: up to 3 years
measure: Safety and tolerability
timeFrame: up to 18 month
measure: Prognostic value of biomarkers
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Guanghai Dai
role: PRINCIPAL_INVESTIGATOR
References:
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