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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
Sponsor:
Information provided by (Responsible Party):
Dai, Guanghai, Chinese PLA General Hospital

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Trastuzumab Drug: Capecitabine Drug: Oxaliplatin Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Trastuzumab,Capecitabine,Oxaliplatin

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.

Drug: Trastuzumab
Trastuzumab is given by intravenous infusion at 440mg on day 0every 3 weeks. Number of cycles: 14~16 cycles.
Other Names:
  • Herceptin
  • Herclon

Drug: Capecitabine

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

Drug: Oxaliplatin

Oxaliplatin is given by intravenous infusion at 130 mg/m2 on day 1 every 3 weeks.

Number of cycles: 8 cycles.

Other Name: Eloxatin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 3 years ]
    Measure of time from study treatment to patient's death or lost to follow-up.

  2. Safety and tolerability [ Time Frame: up to 18 month ]
    Percentage of patients who experience adverse events during this study.

  3. Prognostic value of biomarkers [ Time Frame: up to 3 years ]
    assessment of the relationship between biomarker status and prognosis



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Guanghai Dai, PHD 13801232381 daigh60@sohu.com
Contact: Yan Shi, PHD 13810561979 shibaiwan12@sina.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Guanghai Dai       daigh60@sohu.com   
Contact: Yan Shi    13810561979    shibaiwan12@sina.com   
Principal Investigator: Guanghai Dai         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Guanghai Dai Chinese PLA General Hospital

Publications of Results:

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Responsible Party: Dai, Guanghai, Professor and chief physician, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02250209     History of Changes
Other Study ID Numbers: CGOG20130101005
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: September 2014
Keywords provided by Dai, Guanghai, Chinese PLA General Hospital:
Gastric Cancer
HER2-positive
Trastuzumab
XELOX
Stage III
D2 Gastrectomy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological