T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy
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|ClinicalTrials.gov Identifier: NCT02250209|
Recruitment Status : Unknown
Verified September 2014 by Dai, Guanghai, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : September 26, 2014
Last Update Posted : September 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: Trastuzumab Drug: Capecitabine Drug: Oxaliplatin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trastuzumab Plus XELOX for HER2-positive Stage III Gastric Cancer After D2 Gastrectomy：Prospective Observational Study.|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
Patients receive eight 3-week cycles of oral capecitabine (800-1000 mg/m2 twice daily on days 1-14 of each cycle) ,intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) plus intravenous Trastuzumab (440mg on day 0 of each cycle).
Number of cycle:capecitabine and oxaliplatin --8 cycles; Trastuzumab--14-16 cycles.
Trastuzumab is given by intravenous infusion at 440mg on day 0every 3 weeks. Number of cycles: 14~16 cycles.
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.
Other Name: Xeloda
Oxaliplatin is given by intravenous infusion at 130 mg/m2 on day 1 every 3 weeks.
Number of cycles: 8 cycles.
Other Name: Eloxatin
- 3-year disease-free survival (DFS) [ Time Frame: Measure at every 6 weeks (every 2 cycles) ]Defined as the time from study treatment to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause.
- Overall survival [ Time Frame: up to 3 years ]Measure of time from study treatment to patient's death or lost to follow-up.
- Safety and tolerability [ Time Frame: up to 18 month ]Percentage of patients who experience adverse events during this study.
- Prognostic value of biomarkers [ Time Frame: up to 3 years ]assessment of the relationship between biomarker status and prognosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250209
|Contact: Guanghai Dai, PHDemail@example.com|
|Contact: Yan Shi, PHDfirstname.lastname@example.org|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Guanghai Dai email@example.com|
|Contact: Yan Shi 13810561979 firstname.lastname@example.org|
|Principal Investigator: Guanghai Dai|
|Principal Investigator:||Guanghai Dai||Chinese PLA General Hospital|