- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03791268
General Tissue Response Classification System After Chemotherapy
The Establishment of General Tissue Response Classification System After Chemotherapy According to Gastric Cancer Patients With Neoadjuvant Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jian-Kun Hu, MD, PhD
- Phone Number: 02885422878
- Email: hujkwch@126.com
Study Contact Backup
- Name: Wei-Han Zhang, MD, PhD
- Phone Number: 02885422480
- Email: weihanwch@126.com
Study Locations
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-
Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital, Sichuan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A
Gastric Cancer Patients who underwent Chemotherapy and will have gastric cancer surgery.
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Gastric cancer surgery is performed according to the Japanese Guidelines.
Patients will intraoperative evaluate the edema, fibrosis and exudation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General observation of tissue fibrosis, edema and exudation (Intraoperation)
Time Frame: The 1 day of surgery
|
To assess the degree of fibrosis, edema and exudation in tumor tissue and main perigastric lymph node area during the operation.
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The 1 day of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General observation of tissue edema (Intraoperation)
Time Frame: The 1 day of surgery
|
To assess the degree of edema in tumor tissue and main perigastric lymph node area during the operation.
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The 1 day of surgery
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General observation of tissue exudation (Intraoperation)
Time Frame: The 1 day of surgery
|
To assess the degree of exudation in tumor tissue and main perigastric lymph node area during the operation.
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The 1 day of surgery
|
Histopathology evaluation of edema
Time Frame: The 1 day of surgery
|
To assess the degree of edema in tumor tissue and main perigastric lymph node area by pathological section.
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The 1 day of surgery
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Histopathology evaluation of tissue fibrosis
Time Frame: Postoperative 30 days
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To assess the degree of fibrosis in tumor tissue and main perigastric lymph node area by pathological section.
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Postoperative 30 days
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Postoperative mortality rate
Time Frame: Postoperative 30 days
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Calculated by the number of patients with any operative complication as the numerator and the number of patients undergoing surgical treatment.
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Postoperative 30 days
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Survival outcome
Time Frame: Postoperative 3 Years
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The 3-year overall survival rate
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Postoperative 3 Years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jian-Kun Hu, MD, PhD, West China Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WCH-GC-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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