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Gastric AdenocarcinomaNCT03024450

Trastuzumab Based Therapy in HER2 Positive AGC

An observational study of Gastric Adenocarcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with clinicopathologic factors remain unclear. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Adenocarcinoma
What is being tested?
H+CT
How many people
98 participants
Where
1 siteChina
Study dates
Jan 2012to Dec 2016
How long will I take part?
8 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with HER2 positive advanced or metastatic gastric adenocarcinoma in Shanghai Zhongshan Hospital, Fu Dan University were prospectively collected. HER2 expression was assessed by IHC first. In the cases with IHC 2+, fluorescence in situ hybridization (FISH) was used to detect HER2/neu amplification levels.

Who may be able to join

  • pathology and medical imageology proven advanced gastric adenocarcinoma, inoperable;
  • received trastuzumab plus chemotherapy as the first-line palliative chemotherapy;
  • with measurable lesion with a diameter 20 mm using conventional computed tomography (CT) or magnetic resonance imaging (MRI) scans or 10 mm using spiral CT scans;
  • Eastern Cooperative Oncology Group performance status (ECOG PS ) of 0-2;
  • left ventricular ejection fraction(LVEF) more than 50 percents;
  • sufficient bone marrow, liver and renal function.

Who cannot join

  • received previous systemic therapy for advanced disease (except adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrollment);
  • trastuzumab based adjuvant/neoadjuvant therapy;
  • treatment with any other anticancer therapy (lapatinib, immunotherapy, etc);
  • patients with heart failure, coronary artery disease or myocardial infarction within the previous 6 months.
  • trastuzumab based first line therapy started beyond 4 weeks from the first diagnoses of AGC.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Efficacy and Prognostic Factors of Trastuzumab Based Therapy in HER2 Positive Advanced Gastric Cancer: a Single Center Prospective Observational Study

Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with clinicopathologic factors remain unclear. The object of the study is to determine whether the addition of trastuzumab to first-line chemotherapy improves efficacy compared with chemotherapy alone in HER2 positive AGC.

Read the detailed description

A total of 98 patients with HER2 positive AGC were enrolled in this prospective observational study. All patients were treated with trastuzumab plus chemotherapy as the first line therapy. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.

Being tested
H+CT
Keywords
Gastric cancer, HER2, trastuzumab, prognosis
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H+CTDrug

    Also called trastuzumab plus chemotherapy

    All patients were treated with trastuzumab plus chemotherapy as the first-line therapy. There were no protocol-specified chemotherapy regimens. This is a prospective observational study. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.

Study groups in NCT03024450
Study groupRoleWhat they receive
HER2 positive AGC treated with H+CTHER2 expression was assessed by IHC first. In the cases with IHC 2+, fluorescence in situ hybridization (FISH) was used to detect HER2/neu amplification levels. Only patients with high level of HER2 expression (IHC 3+ or IHC 2+ plus FISH positive) were eligible in this study.
Receives: Drug: H+CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS

    OS was defined as time from the beginning of first line therapy to death

    Measured: 8 years

  2. PFS

    PFS was measured from the start of first line therapy to the date of progressive disease or death, with censoring of patients who were lost to follow-up.

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2017 (estimated)
  2. Study startJan 2012
  3. Primary completionMay 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
98 participants (actual)
Target duration
8 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03024450
Sponsor's protocol ID
ZS-ON-08
Status last verified
Jan 2017
First submitted
2 Jan 2017
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20728210

  • Halon A, Donizy P, Biecek P, Rudno-Rudzinska J, Kielan W, Matkowski R. HER-2 expression in immunohistochemistry has no prognostic significance in gastric cancer patients. ScientificWorldJournal. 2012;2012:941259. doi: 10.1100/2012/941259. Epub 2012 May 3.

    PubMed 22645475

  • Shitara K, Yatabe Y, Matsuo K, Sugano M, Kondo C, Takahari D, Ura T, Tajika M, Ito S, Muro K. Prognosis of patients with advanced gastric cancer by HER2 status and trastuzumab treatment. Gastric Cancer. 2013 Apr;16(2):261-7. doi: 10.1007/s10120-012-0179-9. Epub 2012 Jul 14.

    PubMed 22797858

  • Gomez-Martin C, Lopez-Rios F, Aparicio J, Barriuso J, Garcia-Carbonero R, Pazo R, Rivera F, Salgado M, Salud A, Vazquez-Sequeiros E, Lordick F. A critical review of HER2-positive gastric cancer evaluation and treatment: from trastuzumab, and beyond. Cancer Lett. 2014 Aug 28;351(1):30-40. doi: 10.1016/j.canlet.2014.05.019. Epub 2014 Jun 3.

    PubMed 24943493

  • Gong J, Liu T, Fan Q, Bai L, Bi F, Qin S, Wang J, Xu N, Cheng Y, Bai Y, Liu W, Wang L, Shen L. Optimal regimen of trastuzumab in combination with oxaliplatin/ capecitabine in first-line treatment of HER2-positive advanced gastric cancer (CGOG1001): a multicenter, phase II trial. BMC Cancer. 2016 Feb 8;16:68. doi: 10.1186/s12885-016-2092-9.

    PubMed 26857702

  • Jiang H, Li Q, Yu S, Yu Y, Wang Y, Li W, Cui Y, Liu T. Impact of HER2 expression on outcome in gastric cancer patients with liver metastasis. Clin Transl Oncol. 2017 Feb;19(2):197-203. doi: 10.1007/s12094-016-1523-z. Epub 2016 Jun 20.

    PubMed 27324991

  • Aizawa M, Nagatsuma AK, Kitada K, Kuwata T, Fujii S, Kinoshita T, Ochiai A. Evaluation of HER2-based biology in 1,006 cases of gastric cancer in a Japanese population. Gastric Cancer. 2014 Jan;17(1):34-42. doi: 10.1007/s10120-013-0239-9. Epub 2013 Feb 22.

    PubMed 23430266

  • Li Q, Li H, Jiang H, Feng Y, Cui Y, Wang Y, Ji Y, Yu Y, Li W, Xu C, Yu S, Zhuang R, Liu T. Predictive factors of trastuzumab-based chemotherapy in HER2 positive advanced gastric cancer: a single-center prospective observational study. Clin Transl Oncol. 2018 Jun;20(6):695-702. doi: 10.1007/s12094-017-1772-5. Epub 2017 Nov 22.

    PubMed 29168107

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Adenocarcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03024450, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.

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