Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03791268
Status:
UNKNOWN
Last Update Posted:
2019-01-02
First Post:
2018-12-25
Brief Title:
General Tissue Response Classification System After Chemotherapy
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
The Establishment of General Tissue Response Classification System After Chemotherapy According to Gastric Cancer Patients With Neoadjuvant Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 patientsTherefore the national comprehensive cancer networkNCCNguidelines for gastric cancer treatment2017 version 5recommended that neoadjuvant chemotherapy evidential level category 1 and neoadjuvant chemotherapy evidential level category 2B can be consideredfor locally advanced gastric caner casesT2-4nx
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 chemotherapyradiotherapy However the rating criteria for connective tissue response around the tumor after chemotherapyradiotherapy still remain blank area During the clinical practice surgeons should not ignored the edema and fibrosis of tumor and connective tissue after chemotherapyradiotherapy which existed objectively Recent research generally believed that preoperative chemotherapy withor not with radiotherapy may lead to edema of gastrointestinal tract and perigastric tissues intraoperative effusion and fibrosis of tumor and lymph nodes bearing tissueswhich 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 fibrosisedema 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 chemotherapyradiotherapy and establish corresponding criteria system to explore whether if the tissue fibrosis and edema are involved with the degree of tumor retreat after chemotherapyradiotherapy 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
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 chemotherapyradiotherapy However the rating criteria for connective tissue response around the tumor after chemotherapyradiotherapy still remain blank area During the clinical practice surgeons should not ignored the edema and fibrosis of tumor and connective tissue after chemotherapyradiotherapy which existed objectively Recent research generally believed that preoperative chemotherapy withor not with radiotherapy may lead to edema of gastrointestinal tract and perigastric tissues intraoperative effusion and fibrosis of tumor and lymph nodes bearing tissueswhich 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 fibrosisedema 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 chemotherapyradiotherapy and establish corresponding criteria system to explore whether if the tissue fibrosis and edema are involved with the degree of tumor retreat after chemotherapyradiotherapy 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None