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Gastric CancerNCT03485105

Prediction of Benefit From Adjuvant Chemotherapy for pT1N1 Gastric Cancer

An observational study of Gastric Cancer, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To conduct a retrospective study to prove a hypothesis of "adjuvant chemotherapy provides survival benefit for patients of CTX-benefit group in gastric cancer of pT1N1, especially in high-risk group". Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Gastric Cancer
How many people
1,000 participants
Where
1 siteSouth Korea
Study dates
1 Nov 2017to 1 Nov 2019
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 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: approximately 1,000 patients Formalin-fixed, paraffin-embedded (FFPE) sample blocks from patients who treated at Severance Hospital and Samsung Hospital for gastric cancer (satisfied with below criteria) with pT1N1 stage and their corresponding clinical information will be evaluated from 1990-2012, approximately 500 participants in each hospital).

Who may be able to join

  • Pathologically confirmed gastric adenocarcinoma
  • Patients who received R0 resection with curative intent surgery
  • pT1 (mucosa/submucosa) N1(one or two metastatic lymph nodes) M0
  • patients received surgery with lymph node dissection of D1 + or more
  • number of retrieved lymph nodes >15
  • Formalin-Fixed Paraffin-Embedded cancer tissues are available
  • Adults over 19 years

Who cannot join

  • Patients received pre-operative chemotherapy or radiotherapy
  • Cancer in remnant stomach (history of gastrectomy)
  • in hospital mortality or died within 30 days after surgery
  • FFPE is not available

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Division of Upper Gastrointestinal Surgery, Department of Surgery, Yonsei University College of Medicine

    Seoul, 03722

Other trials in South Korea

About this study

Official title: Prediction of Benefit From Adjuvant Chemotherapy for pT1N1 Gastric Cancer: A Pilot Retrospective Multicenter Cohort Study

To conduct a retrospective study to prove a hypothesis of "adjuvant chemotherapy provides survival benefit for patients of CTX-benefit group in gastric cancer of pT1N1, especially in high-risk group". This study is a pilot study and the result will be used as a reference for the upcoming prospective randomized controlled trial for same issue including estimating sample size. Two high-volume hospitals (Yonsei University Severance Hospital and Samsung Hospital) will participant this pilot study.

FFPE sample blocks and clinical information pertaining to the patients who satisfied with selection criteria will be collected from two institutions. The primary end point of this study is disease-free survival (DFS) that is defined as the time from surgery to death or gastric cancer recurrence whichever occurred first; and overall survival (OS) that is defined as time from surgery to death by any causes. Clinical information such as age, sex, histology, Lauren classification, depth of invasion, number of retrieved and metastatic lymph nodes, sizes of tumor, location of tumor, gross type, lympho-vascular invasion, received chemotherapy or not will be centralized.

One or 2 of 3mm core of tumor will be punched from FFPE and it will be delivered through Eppendorf tube to laboratory (Novomics Co. Ltd., Seoul, Korea). RNA will be extracted from the tissue and the pattern of RNA expression will be evaluated and each sample will be categorized into three risk group (high, intermediate, low risk group) and two predictive group (CTX-benefit and no-benefit group) by GMP-grade nProfiler 1TM Stomach Cancer Assay Kit (Novomics Co. Ltd., Seoul, Korea). Both clinical information and classification will be delivered to independent statisticians who are responsible to conduct statistical analyses.

Conditions
Gastric Cancer
Keywords
Gastric cancer, biomarker, chemotherapy, precise medicine
Medical subject headings
Stomach Neoplasms

What participants receive

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

Study groups in NCT03485105
Study groupRoleWhat they receive
CTX-benefit groupCTX-benefit group: based on the result of nProfiler Stomach cancer assay kit which was decided by expression level of mRNA, this group will be beneficial from adjuvant chemotherapy
no-benefit groupno-benefit group: based on the result of nProfiler Stomach cancer assay kit which was decided by expression level of mRNA, this group will not be beneficial from adjuvant chemotherapy
high-risk grouphigh-risk group: based on the result of nProfiler Stomach cancer assay kit which was decided by expression level of mRNA, the prognosis of this group will be worse compared to others regardless of the response to adjuvant chemotherapy

What is being measured

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

  1. Disease free survival

    Disease free survival which is defined as the time from surgery to death or gastric cancer recurrence whichever occurred first, and overall survival that is defined as time from surgery to death by any causes

    Measured: average 5 years to detect recurrence of tumor

  2. overall survival

    overall survival that is defined as time from surgery to death by any causes. Survival difference between surgery only vs. surgery plus adjuvant treatment (chemotherapy or chemo-radiotherapy) will be analyzed according to subgroup (CTX-benefit and no-benefit group in overall and high-risk group)

    Measured: average of follow up duration will be 60 months

Timeline

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

  1. First posted2 Apr 2018
  2. Study start1 Nov 2017
  3. Primary completion1 Oct 2019 (estimated)
  4. Study completion1 Nov 2019 (estimated)

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
Retrospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03485105
Sponsor's protocol ID
4-2017-0914
Status last verified
Mar 2018
First submitted
26 Mar 2018
Last updated
9 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cheong JH, Yang HK, Kim H, Kim WH, Kim YW, Kook MC, Park YK, Kim HH, Lee HS, Lee KH, Gu MJ, Kim HY, Lee J, Choi SH, Hong S, Kim JW, Choi YY, Hyung WJ, Jang E, Kim H, Huh YM, Noh SH. Predictive test for chemotherapy response in resectable gastric cancer: a multi-cohort, retrospective analysis. Lancet Oncol. 2018 May;19(5):629-638. doi: 10.1016/S1470-2045(18)30108-6. Epub 2018 Mar 19.

    PubMed 29567071

  • Nakajima T, Nashimoto A, Kitamura M, Kito T, Iwanaga T, Okabayashi K, Goto M. Adjuvant mitomycin and fluorouracil followed by oral uracil plus tegafur in serosa-negative gastric cancer: a randomised trial. Gastric Cancer Surgical Study Group. Lancet. 1999 Jul 24;354(9175):273-7. doi: 10.1016/s0140-6736(99)01048-x.

    PubMed 10440302

  • Shin HB, An JY, Lee SH, Choi YY, Kim JW, Sohn SS, Noh SH. Is adjuvant chemotherapy necessary in pT1N1 gastric cancer? BMC Cancer. 2017 Apr 22;17(1):287. doi: 10.1186/s12885-017-3265-x.

    PubMed 28431518

  • Noh SH, Park SR, Yang HK, Chung HC, Chung IJ, Kim SW, Kim HH, Choi JH, Kim HK, Yu W, Lee JI, Shin DB, Ji J, Chen JS, Lim Y, Ha S, Bang YJ; CLASSIC trial investigators. Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1389-96. doi: 10.1016/S1470-2045(14)70473-5. Epub 2014 Oct 15.

    PubMed 25439693

  • 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.

    PubMed 22010012

  • Japanese Gastric Cancer Association. Japanese classification of gastric carcinoma: 3rd English edition. Gastric Cancer. 2011 Jun;14(2):101-12. doi: 10.1007/s10120-011-0041-5. No abstract available.

    PubMed 21573743

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer, run by Yonsei University at 1 site in South Korea.

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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Apr 2018. 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 South Korea. 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?

Results are not available in the source record.

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?

Disease free survival (time frame: average 5 years to detect recurrence of tumor). 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 NCT03485105, which also lists 6 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 9 Apr 2018.

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