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

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Trastuzumab

Capecitabine

Oxaliplatin

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, HER2-positive, Trastuzumab, XELOX, Stage III, D2 Gastrectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Patients who do not meet the Inclusion Criteria.
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.

Sites / Locations

Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trastuzumab,Capecitabine,Oxaliplatin

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival

Measure of time from study treatment to patient's death or lost to follow-up.

Safety and tolerability

Percentage of patients who experience adverse events during this study.

Prognostic value of biomarkers

assessment of the relationship between biomarker status and prognosis

Full Information

NCT ID

NCT02250209

First Posted

September 24, 2014

Last Updated

September 24, 2014

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02250209

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

Gastric Cancer, HER2-positive, Trastuzumab, XELOX, Stage III, D2 Gastrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trastuzumab,Capecitabine,Oxaliplatin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Other Intervention Name(s)

Herceptin, Herclon

Intervention Description

Trastuzumab is given by intravenous infusion at 440mg on day 0every 3 weeks. Number of cycles: 14~16 cycles.

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

Eloxatin

Intervention Description

Oxaliplatin is given by intravenous infusion at 130 mg/m2 on day 1 every 3 weeks. Number of cycles: 8 cycles.

Primary Outcome Measure Information:

Title

3-year disease-free survival (DFS)

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.

Time Frame

Measure at every 6 weeks (every 2 cycles)

Secondary Outcome Measure Information:

Title

Overall survival

Description

Measure of time from study treatment to patient's death or lost to follow-up.

Time Frame

up to 3 years

Title

Safety and tolerability

Description

Percentage of patients who experience adverse events during this study.

Time Frame

up to 18 month

Title

Prognostic value of biomarkers

Description

assessment of the relationship between biomarker status and prognosis

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Patients who do not meet the Inclusion Criteria. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guanghai Dai, PHD

Phone

13801232381

daigh60@sohu.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Shi, PHD

Phone

13810561979

shibaiwan12@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guanghai Dai

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guanghai Dai

daigh60@sohu.com

First Name & Middle Initial & Last Name & Degree

Yan Shi

Phone

13810561979

shibaiwan12@sina.com

First Name & Middle Initial & Last Name & Degree

Guanghai Dai

12. IPD Sharing Statement

Citations:

PubMed Identifier

22226517

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.

Results Reference

result

PubMed Identifier

18441328

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.

Results Reference

result

PubMed Identifier

18422971

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.

Results Reference

result

PubMed Identifier

15668283

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.

Results Reference

result

PubMed Identifier

16236737

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.

Results Reference

result

PubMed Identifier

11248153

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.

Results Reference

result

PubMed Identifier

20728210

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.

Results Reference

result

PubMed Identifier

17208639

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.

Results Reference

result

PubMed Identifier

22534547

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.

Results Reference

result

PubMed Identifier

22977193

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.

Results Reference

result

PubMed Identifier

23233651

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.

Results Reference

result

PubMed Identifier

22010012

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.

Results Reference

result

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

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