T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy

September 24, 2014 updated by: Dai, Guanghai, Chinese PLA General Hospital

Trastuzumab Plus XELOX for HER2-positive Stage III Gastric Cancer After D2 Gastrectomy：Prospective Observational Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guanghai Dai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Eloxatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measure at every 6 weeks (every 2 cycles)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: up to 3 years
Measure of time from study treatment to patient's death or lost to follow-up.
up to 3 years
Safety and tolerability
Time Frame: up to 18 month
Percentage of patients who experience adverse events during this study.
up to 18 month
Prognostic value of biomarkers
Time Frame: up to 3 years
assessment of the relationship between biomarker status and prognosis
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Guanghai Dai, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGOG20130101005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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