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Stomach AdenocarcinomaNCT03791268

General Tissue Response Classification System After Chemotherapy

An observational study of Stomach Adenocarcinoma, run by West China Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This research intend to collect the information of gastric cancer patients who received preoperative neoadjuvant chemotherapy and radical gastric ectomy at Department of Gastrointestinal Surgery, West China Hospital, Sichuan University. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stomach Adenocarcinoma
What is being tested?
Gastric cancer surgery
Type of treatment
Surgery or procedure
How many people
200 participants
Where
1 siteChina
Study dates
1 Jan 2019to 31 Dec 2020
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Gastric cancer patients who received preoperative neoadjuvant chemotherapy and radical gastric ectomy at Department of Gastrointestinal Surgery, West China Hospital, Sichuan University

Who may be able to join

  • The diagnosis of gastric cancer was clear,Patients with definitely clinical evidence of locally advanced disease (cT3 ⁄ 4、N-/+、M0).
  • Preoperative chemotherapy has been administered,and intended to receive surgical resection.
  • Age:less than or equal to 75 years old and more than 18 years old;
  • Without any other malignant tumor, without any serious concomitant disease.
  • Eastern Cooperative Oncology Group (ECOG) physical status score <2, America Society of Anesthesiologist (ASA) score<3
  • No restriction on gender or race; Informed consent has been signed by patient or entrusted agent;

Who cannot join

  • Previous history of gastric ulcer or gastric perforation;
  • Previous operation history at upper abdominal, except laparoscopic cholecystectomy;
  • Emergency operation caused by obstruction, perforation,and acute hemorrhage;
  • The patient can not tolerate the surgical treatment which caused by other serious concomitant disease, such as severe pulmonary disease, cardiac clinical function below are below level 2, pulmonary infection, moderate or severe chronic obstructive pulmonary disease (COPD), chronic bronchitis
  • Patient has severe mental illness
  • The patient and agent request to withdraw from the clinical study after signing the consent form.

Trial locations and contacts

1 site in 1 country.

Jian-Kun Hu, MD, PhD contact

02885422878

hujkwch@126.com

Wei-Han Zhang, MD, PhD contact

02885422480

weihanwch@126.com

China1 site
  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: The Establishment of General Tissue Response Classification System After Chemotherapy According to Gastric Cancer Patients With Neoadjuvant Chemotherapy

This research intend to collect the information of gastric cancer patients who received preoperative neoadjuvant chemotherapy and radical gastric ectomy at Department of Gastrointestinal Surgery, West China Hospital, Sichuan University. Base on The degree of edema, intraoperative effusion, fibrosis of connecting tissues, the investigators aim to constitute the core parameters of the tissue response grading system following neoadjuvant chemotherapy, and explore the mutual effect among the tissue response grading system, tumor regression response and long-term survival outcome of tumor patients.

Read the detailed description

Gastric cancer is ranked the third malignancy carcinoma which related deaths. In china, gastric cancer always ranked in the top three cancer-related deaths. Early diagnosis ratio of gastric caner is low in china. And the proportion of gastric cancer cases which performed surgical treatment is less than 20% at early stage Therefore, the vast majority of patients with gastric carcinoma already have locally advanced tumors at the time of diagnosis in china, and the current treatment strategy is suggested to receive comprehensive surgical gastrectomy. Current research showed strong evidence that preoperative neoadjuvant therapy represented by neoadjuvant chemotherapy (NAC) can downstaging the primary tumor to increase the possibility of a successful complete resection and destroying occult lymph node and distant micro metastases to decrease the rate of tumor recurrence., and thus provide the survival benefit for locally advanced gastric cancer patients.Therefore, the national comprehensive cancer network(NCCN)guidelines for gastric cancer treatment(2017 version 5),recommended that neoadjuvant chemotherapy (evidential level category 1 ) and neoadjuvant chemotherapy (evidential level category 2B) can be considered.for locally advanced gastric caner cases(T2-4nx).

Through the literature review, the investigators found that residual tumor evaluation criteria which was promoted by Becker and the criteria for tumor regression response which recommended by NCCN guidelines can be used to evaluate the tumor regression after chemotherapy/radiotherapy. However, the rating criteria for connective tissue response around the tumor after chemotherapy/radiotherapy still remain blank area. During the clinical practice, surgeons should not ignored the edema and fibrosis of tumor and connective tissue after chemotherapy/radiotherapy which existed objectively. Recent research generally believed that preoperative chemotherapy with/or not with radiotherapy may lead to edema of gastrointestinal tract and perigastric tissues, intraoperative effusion and fibrosis of tumor and lymph nodes bearing tissues,which may increase the difficulty of tissue dissociation and lymph node dissection, increase the risk of surgical trauma, and may lead to increased incidence of postoperative complications. There is till a lack of evaluation criteria for the degree of tissue fibrosis/edema after radiotherapy and chemotherapy which may have impact on surgery and long-term survival prognosis of patients.

Therefore, it is necessary to analyze and evaluate tissue edema and fibrosis after chemotherapy/radiotherapy and establish corresponding criteria system to explore whether if the tissue fibrosis and edema are involved with the degree of tumor retreat after chemotherapy/radiotherapy at two aspects: general evaluation and histopathology. The interaction effects of tissue fibrosis and edema with the difficulty of operation and incidence rate of postoperative complications. In addition, the mutual effect of tissue fibrosis and edema with the final long-term survival outcome of tumor patients needs to be evaluated from two aspects: general observation and histopathology evaluation.

Being tested
Gastric cancer surgery
Keywords
Stomach Adenocarcinoma, neoadjuvant chemotherapy

What participants receive

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

  • Gastric cancer surgeryProcedure or surgery

    Gastric cancer surgery is performed according to the Japanese Guidelines. Patients will intraoperative evaluate the edema, fibrosis and exudation.

Study groups in NCT03791268
Study groupRoleWhat they receive
Group AGastric Cancer Patients who underwent Chemotherapy and will have gastric cancer surgery.
Receives: Procedure: Gastric cancer surgery

What is being measured

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

  1. General observation of tissue fibrosis, edema and exudation (Intraoperation)

    To assess the degree of fibrosis, edema and exudation in tumor tissue and main perigastric lymph node area during the operation.

    Measured: The 1 day of surgery

Secondary outcomes (6)
  1. General observation of tissue edema (Intraoperation)

    To assess the degree of edema in tumor tissue and main perigastric lymph node area during the operation.

    Measured: The 1 day of surgery

  2. General observation of tissue exudation (Intraoperation)

    To assess the degree of exudation in tumor tissue and main perigastric lymph node area during the operation.

    Measured: The 1 day of surgery

  3. Histopathology evaluation of edema

    To assess the degree of edema in tumor tissue and main perigastric lymph node area by pathological section.

    Measured: The 1 day of surgery

  4. Histopathology evaluation of tissue fibrosis

    To assess the degree of fibrosis in tumor tissue and main perigastric lymph node area by pathological section.

    Measured: Postoperative 30 days

  5. Postoperative mortality rate

    Calculated by the number of patients with any operative complication as the numerator and the number of patients undergoing surgical treatment.

    Measured: Postoperative 30 days

  6. Survival outcome

    The 3-year overall survival rate

    Measured: Postoperative 3 Years

Timeline

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

  1. First posted2 Jan 2019
  2. Study start1 Jan 2019 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (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
Case only
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03791268
Sponsor's protocol ID
WCH-GC-06
Status last verified
Dec 2018
First submitted
25 Dec 2018
Last updated
2 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yang H, Zhang WH, Ge R, Peng BQ, Chen XZ, Yang K, Liu K, Chen XL, He D, Liu JP, Zhang WW, Qin Y, Zhou ZG, Hu JK. Application of Gross Tissue Response System in Gastric Cancer After Neoadjuvant Chemotherapy: A Primary Report of a Prospective Cohort Study. Front Oncol. 2021 Nov 24;11:585006. doi: 10.3389/fonc.2021.585006. eCollection 2021.

    PubMed 34900661

Questions about this trial

What is this clinical trial studying?

An observational study of Stomach Adenocarcinoma, run by West China 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 6 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 2 Jan 2019. 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?

Results are not available in the source record.

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

Contact Jian-Kun Hu, MD, PhD (02885422878, hujkwch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

General observation of tissue fibrosis, edema and exudation (Intraoperation) (time frame: The 1 day of surgery). 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 NCT03791268, which also lists 1 linked publication.

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 2 Jan 2019.

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