<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02250209</url>
  </required_header>
  <id_info>
    <org_study_id>CGOG20130101005</org_study_id>
    <nct_id>NCT02250209</nct_id>
  </id_info>
  <brief_title>T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy</brief_title>
  <official_title>Trastuzumab Plus XELOX for HER2-positive Stage III Gastric Cancer After D2 Gastrectomy：Prospective Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to assess the clinical efficacy and safety of trastuzumab plus&#xD;
      XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastric cancer is the second leading cause of cancer death worldwide. Highest incidence rate&#xD;
      is observed in Eastern Asia.&#xD;
&#xD;
      D2 gastrectomy has been established as a standard surgical procedure. While recurrence rate&#xD;
      after resection is still high.&#xD;
&#xD;
      The CLASSIC study showed that Xelox regimen after D2 gastrectomy improves 3-year disease-free&#xD;
      survival compared with surgery only. But patients with late stage still have poor prognosis&#xD;
      according to subgroup analysis and our retrospective study.&#xD;
&#xD;
      HER2 is an important biomarker and key driver of tumorigenesis in 7-34% gastric cancers. The&#xD;
      ToGA study showed that trastuzumab, a monoclonal antibody that targets HER2, plus&#xD;
      chemotherapy improved overall survival(16.0m vs 11.8m) in patients with HER2-positive&#xD;
      advanced gastric or gastro-oesophageal junction cancer.&#xD;
&#xD;
      Based on previous experiences of trastuzumab in adjunctive therapy of breast cancer and&#xD;
      ACTS/CLASSIC/ToGA studies, we suppose that trastuzumab plus XELOX as adjunctive treatment may&#xD;
      benefit patients with HER2-positive Stage III gastric cancer after D2 Gastrectomy.&#xD;
&#xD;
      According to the above, we do this single-arm research to assess the clinical efficacy and&#xD;
      safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer&#xD;
      After D2 Gastrectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-year disease-free survival (DFS)</measure>
    <time_frame>Measure at every 6 weeks (every 2 cycles)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Measure of time from study treatment to patient's death or lost to follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>up to 18 month</time_frame>
    <description>Percentage of patients who experience adverse events during this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognostic value of biomarkers</measure>
    <time_frame>up to 3 years</time_frame>
    <description>assessment of the relationship between biomarker status and prognosis</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Trastuzumab,Capecitabine,Oxaliplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).&#xD;
Number of cycle:capecitabine and oxaliplatin --8 cycles; Trastuzumab--14-16 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <description>Trastuzumab is given by intravenous infusion at 440mg on day 0every 3 weeks. Number of cycles: 14~16 cycles.</description>
    <arm_group_label>Trastuzumab,Capecitabine,Oxaliplatin</arm_group_label>
    <other_name>Herceptin</other_name>
    <other_name>Herclon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Capecitabine 800~1000 mg/m² is given orally twice a day for 14 days followed by a 1-week rest.&#xD;
Number of cycles: 8 cycles.</description>
    <arm_group_label>Trastuzumab,Capecitabine,Oxaliplatin</arm_group_label>
    <other_name>Xeloda</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Oxaliplatin is given by intravenous infusion at 130 mg/m2 on day 1 every 3 weeks.&#xD;
Number of cycles: 8 cycles.</description>
    <arm_group_label>Trastuzumab,Capecitabine,Oxaliplatin</arm_group_label>
    <other_name>Eloxatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed-consent form.&#xD;
&#xD;
          2. Aged 18-80 years.&#xD;
&#xD;
          3. Had partial or total D2 gastrectomy and achieved R0 resection.&#xD;
&#xD;
          4. Histologically confirmed gastric or gastro-oesophageal junction&#xD;
             adenocarcinoma，mucinous adenocarcinoma ，signet-ring cell carcinoma&#xD;
&#xD;
          5. Pathologic Stage III (IIIA-C).&#xD;
&#xD;
          6. HER2-positive: (IHC 3+ or IHC 2+ and FISH positive).&#xD;
&#xD;
          7. Patients must have received no preoperative chemotherapy or radiation therapy.&#xD;
&#xD;
          8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 .&#xD;
&#xD;
          9. Adequate liver/bone marrow function.Blood and biochemical parameters;&#xD;
&#xD;
         10. Compliant, and can be followed up regularly.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who do not meet the Inclusion Criteria.&#xD;
&#xD;
          2. Pregnant or breast-feeding female, or not willing to take contraception measures&#xD;
             during study.&#xD;
&#xD;
          3. Serious infection requiring antibiotics intervention during recruitment.&#xD;
&#xD;
          4. Allergic to study drug or with metabolism disorder.&#xD;
&#xD;
          5. Histologically confirmed small cell carcinoma of the stomach、gastric neuroendocrine&#xD;
             carcinoma or others.&#xD;
&#xD;
          6. Uncontrolled brain metastasis or mental illness.&#xD;
&#xD;
          7. Organ transplant recipients (Autologous transplantation of bone marrow and peripheral&#xD;
             stem cell transplantation included).&#xD;
&#xD;
          8. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.&#xD;
&#xD;
          9. With severe hepatic/kidney/respirator/disease,or chronic disease like uncontrolled&#xD;
             diabetes,hypertension,etc.&#xD;
&#xD;
         10. with other malignant tumors.&#xD;
&#xD;
         11. Can be followed up or obey protocol.&#xD;
&#xD;
         12. Ineligible by the discretion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guanghai Dai</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guanghai Dai, PHD</last_name>
    <phone>13801232381</phone>
    <email>daigh60@sohu.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yan Shi, PHD</last_name>
    <phone>13810561979</phone>
    <email>shibaiwan12@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guanghai Dai</last_name>
      <email>daigh60@sohu.com</email>
    </contact>
    <contact_backup>
      <last_name>Yan Shi</last_name>
      <phone>13810561979</phone>
      <email>shibaiwan12@sina.com</email>
    </contact_backup>
    <investigator>
      <last_name>Guanghai Dai</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.</citation>
    <PMID>22226517</PMID>
  </results_reference>
  <results_reference>
    <citation>Gravalos C, Jimeno A. HER2 in gastric cancer: a new prognostic factor and a novel therapeutic target. Ann Oncol. 2008 Sep;19(9):1523-9. doi: 10.1093/annonc/mdn169. Epub 2008 Apr 25.</citation>
    <PMID>18441328</PMID>
  </results_reference>
  <results_reference>
    <citation>Hofmann M, Stoss O, Shi D, Buttner R, van de Vijver M, Kim W, Ochiai A, Ruschoff J, Henkel T. Assessment of a HER2 scoring system for gastric cancer: results from a validation study. Histopathology. 2008 Jun;52(7):797-805. doi: 10.1111/j.1365-2559.2008.03028.x. Epub 2008 Apr 18.</citation>
    <PMID>18422971</PMID>
  </results_reference>
  <results_reference>
    <citation>Tanner M, Hollmen M, Junttila TT, Kapanen AI, Tommola S, Soini Y, Helin H, Salo J, Joensuu H, Sihvo E, Elenius K, Isola J. Amplification of HER-2 in gastric carcinoma: association with Topoisomerase IIalpha gene amplification, intestinal type, poor prognosis and sensitivity to trastuzumab. Ann Oncol. 2005 Feb;16(2):273-8. doi: 10.1093/annonc/mdi064.</citation>
    <PMID>15668283</PMID>
  </results_reference>
  <results_reference>
    <citation>Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang CS, Andersson M, Inbar M, Lichinitser M, Lang I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Ruschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72. doi: 10.1056/NEJMoa052306.</citation>
    <PMID>16236737</PMID>
  </results_reference>
  <results_reference>
    <citation>Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. doi: 10.1056/NEJM200103153441101.</citation>
    <PMID>11248153</PMID>
  </results_reference>
  <results_reference>
    <citation>Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. Erratum In: Lancet. 2010 Oct 16;376(9749):1302.</citation>
    <PMID>20728210</PMID>
  </results_reference>
  <results_reference>
    <citation>Smith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, Goldhirsch A, Untch M, Mariani G, Baselga J, Kaufmann M, Cameron D, Bell R, Bergh J, Coleman R, Wardley A, Harbeck N, Lopez RI, Mallmann P, Gelmon K, Wilcken N, Wist E, Sanchez Rovira P, Piccart-Gebhart MJ; HERA study team. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007 Jan 6;369(9555):29-36. doi: 10.1016/S0140-6736(07)60028-2.</citation>
    <PMID>17208639</PMID>
  </results_reference>
  <results_reference>
    <citation>Dai GH, Shi Y, Chen L, Lv YL, Zhong M. Trastuzumab combined with docetaxel-based regimens in previously treated metastatic gastric cancer patients with HER2 over-expression. Hepatogastroenterology. 2012 Nov-Dec;59(120):2439-44. doi: 10.5754/hge12166.</citation>
    <PMID>22534547</PMID>
  </results_reference>
  <results_reference>
    <citation>Terashima M, Kitada K, Ochiai A, Ichikawa W, Kurahashi I, Sakuramoto S, Katai H, Sano T, Imamura H, Sasako M; ACTS-GC Group. Impact of expression of human epidermal growth factor receptors EGFR and ERBB2 on survival in stage II/III gastric cancer. Clin Cancer Res. 2012 Nov 1;18(21):5992-6000. doi: 10.1158/1078-0432.CCR-12-1318. Epub 2012 Sep 12.</citation>
    <PMID>22977193</PMID>
  </results_reference>
  <results_reference>
    <citation>Okines AF, Thompson LC, Cunningham D, Wotherspoon A, Reis-Filho JS, Langley RE, Waddell TS, Noor D, Eltahir Z, Wong R, Stenning S. Effect of HER2 on prognosis and benefit from peri-operative chemotherapy in early oesophago-gastric adenocarcinoma in the MAGIC trial. Ann Oncol. 2013 May;24(5):1253-61. doi: 10.1093/annonc/mds622. Epub 2012 Dec 11.</citation>
    <PMID>23233651</PMID>
  </results_reference>
  <results_reference>
    <citation>Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, Nashimoto A, Fujii M, Nakajima T, Ohashi Y. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011 Nov 20;29(33):4387-93. doi: 10.1200/JCO.2011.36.5908. Epub 2011 Oct 17.</citation>
    <PMID>22010012</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Dai, Guanghai</investigator_full_name>
    <investigator_title>Professor and chief physician</investigator_title>
  </responsible_party>
  <keyword>Gastric Cancer</keyword>
  <keyword>HER2-positive</keyword>
  <keyword>Trastuzumab</keyword>
  <keyword>XELOX</keyword>
  <keyword>Stage III</keyword>
  <keyword>D2 Gastrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Trastuzumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02250209
org study id: CGOG20130101005
nct id: NCT02250209
lead sponsor: 
has dmc: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3-year disease-free survival (DFS)
time frame: Measure at every 6 weeks (every 2 cycles)
description: 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: Overall survival
time frame: up to 3 years
description: Measure of time from study treatment to patient's death or lost to follow-up.
measure: Safety and tolerability
time frame: up to 18 month
description: Percentage of patients who experience adverse events during this study.
measure: Prognostic value of biomarkers
time frame: up to 3 years
description: assessment of the relationship between biomarker status and prognosis
arm group label: Trastuzumab,Capecitabine,Oxaliplatin
arm group type: Experimental
description: 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.
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
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Guanghai Dai
role: Principal Investigator
affiliation: Chinese PLA General Hospital
last name: Guanghai Dai, PHD
phone: 13801232381
email: daigh60@sohu.com
last name: Yan Shi, PHD
phone: 13810561979
email: shibaiwan12@sina.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
citation: Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.
PMID: 22226517
citation: Gravalos C, Jimeno A. HER2 in gastric cancer: a new prognostic factor and a novel therapeutic target. Ann Oncol. 2008 Sep;19(9):1523-9. doi: 10.1093/annonc/mdn169. Epub 2008 Apr 25.
PMID: 18441328
citation: Hofmann M, Stoss O, Shi D, Buttner R, van de Vijver M, Kim W, Ochiai A, Ruschoff J, Henkel T. Assessment of a HER2 scoring system for gastric cancer: results from a validation study. Histopathology. 2008 Jun;52(7):797-805. doi: 10.1111/j.1365-2559.2008.03028.x. Epub 2008 Apr 18.
PMID: 18422971
citation: Tanner M, Hollmen M, Junttila TT, Kapanen AI, Tommola S, Soini Y, Helin H, Salo J, Joensuu H, Sihvo E, Elenius K, Isola J. Amplification of HER-2 in gastric carcinoma: association with Topoisomerase IIalpha gene amplification, intestinal type, poor prognosis and sensitivity to trastuzumab. Ann Oncol. 2005 Feb;16(2):273-8. doi: 10.1093/annonc/mdi064.
PMID: 15668283
citation: Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang CS, Andersson M, Inbar M, Lichinitser M, Lang I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Ruschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72. doi: 10.1056/NEJMoa052306.
PMID: 16236737
citation: Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. doi: 10.1056/NEJM200103153441101.
PMID: 11248153
citation: Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. Erratum In: Lancet. 2010 Oct 16;376(9749):1302.
PMID: 20728210
citation: Smith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, Goldhirsch A, Untch M, Mariani G, Baselga J, Kaufmann M, Cameron D, Bell R, Bergh J, Coleman R, Wardley A, Harbeck N, Lopez RI, Mallmann P, Gelmon K, Wilcken N, Wist E, Sanchez Rovira P, Piccart-Gebhart MJ; HERA study team. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007 Jan 6;369(9555):29-36. doi: 10.1016/S0140-6736(07)60028-2.
PMID: 17208639
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responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Dai, Guanghai
investigator title: Professor and chief physician
mesh term: Stomach Neoplasms
mesh term: Capecitabine
mesh term: Oxaliplatin
mesh term: Trastuzumab