T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy
Trastuzumab Plus XELOX for HER2-positive Stage III Gastric Cancer After D2 Gastrectomy：Prospective Observational Study.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 gastric-cancer
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 24, 2014
CompletedFirst Posted
Study publicly available on registry
September 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 26, 2014
September 1, 2014
2.9 years
September 24, 2014
September 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year disease-free survival (DFS)
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 Outcomes (3)
Overall survival
up to 3 years
Safety and tolerability
up to 18 month
Prognostic value of biomarkers
up to 3 years
Study Arms (1)
Trastuzumab,Capecitabine,Oxaliplatin
EXPERIMENTALPatients 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.
Interventions
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.
Oxaliplatin is given by intravenous infusion at 130 mg/m2 on day 1 every 3 weeks. Number of cycles: 8 cycles.
Eligibility Criteria
You may qualify if:
- Signed informed-consent form.
- Aged 18-80 years.
- Had partial or total D2 gastrectomy and achieved R0 resection.
- Histologically confirmed gastric or gastro-oesophageal junction adenocarcinoma，mucinous adenocarcinoma ，signet-ring cell carcinoma
- Pathologic Stage III (IIIA-C).
- HER2-positive: (IHC 3+ or IHC 2+ and FISH positive).
- Patients must have received no preoperative chemotherapy or radiation therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 .
- Adequate liver/bone marrow function.Blood and biochemical parameters;
- Compliant, and can be followed up regularly.
You may not qualify if:
- Pregnant or breast-feeding female, or not willing to take contraception measures during study.
- Serious infection requiring antibiotics intervention during recruitment.
- Allergic to study drug or with metabolism disorder.
- Histologically confirmed small cell carcinoma of the stomach、gastric neuroendocrine carcinoma or others.
- Uncontrolled brain metastasis or mental illness.
- Organ transplant recipients (Autologous transplantation of bone marrow and peripheral stem cell transplantation included).
- Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
- With severe hepatic/kidney/respirator/disease,or chronic disease like uncontrolled diabetes,hypertension,etc.
- with other malignant tumors.
- Can be followed up or obey protocol.
- Ineligible by the discretion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Related Publications (12)
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: 22226517RESULTGravalos 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: 18441328RESULTHofmann 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: 18422971RESULTTanner 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: 15668283RESULTPiccart-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: 16236737RESULTSlamon 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: 11248153RESULTBang 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.
PMID: 20728210RESULTSmith 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: 17208639RESULTDai 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.
PMID: 22534547RESULTTerashima 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.
PMID: 22977193RESULTOkines 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.
PMID: 23233651RESULTSasako 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.
PMID: 22010012RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guanghai Dai
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and chief physician
Study Record Dates
First Submitted
September 24, 2014
First Posted
September 26, 2014
Study Start
July 1, 2014
Primary Completion
June 1, 2017
Study Completion
December 1, 2017
Last Updated
September 26, 2014
Record last verified: 2014-09