Ignite Creation Date:
2024-05-06 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03680261
Status:
UNKNOWN
Last Update Posted:
2018-09-21
First Post:
2018-09-19
Brief Title:
Enriched-CRT 2017 Advanced Gastric Cancer With LN and LVI Chemotherapy vs Chemoradiotherapy
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Phase III Multicenter Randomized Controlled Trial of Adjuvant Chemoradiotherapy vs Chemotherapy for Radical Resected Advanced Gastric Carcinoma Concurrent With Lymph Node Metastasis and Lymphovascular Invasion
Status:
UNKNOWN
Status Verified Date:
2018-09
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 Enriched-CRT 2017 trial is a prospective multicenter trial for adjuvant chemoradiotherapy CRT and chemotherapy CT in radical resected advanced gastric cancer GC patients with lymph node metastasis LN and lymphovascular Invasion LVI The primary purpose of this study is to evaluate the 3-year overall survival OS of enrolled patients receiving adjuvant chemoradiotherapy compared with those receiving adjuvant chemotherapy The second purpose is to evaluate 3-year disease free survival DFS and determine the safety of CRT compared with CT in the patients enrolled in this study
Detailed Description:
Gastric cancer is an important health problem being the fourth most common cancer and the third leading cause of cancer-related death worldwide Age standardized mortality rates for gastric cancer are 143 per 100 000 in men and 69 per 100 000 in women More than 679 000 new cases and 498000 deaths occur every year in China
Local recurrence is considered as the most common way of recurrence for advanced gastric cancer as well as an important factor for poor prognosis Radiotherapy is a widely used technique in Western countries and has been identified to have a significant role in decreasing local recurrence rate in breast cancer and colon rectal cancer At this moment several randomized controlled trials have been conducted to identify the role of radiotherapy in advanced gastric cancer Although the results from Europe INT-0116 Dutch CRITICS and Korea ARTIST did not find that radiotherapy could improve the overall survival of enrolled patients the sub-group analyses demonstrated that radiotherapy could improve the disease-free survival in patients with lymph node metastasis We also found that adjuvant chemoradiotherapy could improve the survival of patients with lymph node metastasis or lymphovascular Invasion based on a large cohort study from National Cancer Database
Therefore our hypothesis is that advanced gastric cancer patients with lymph node metastasis or lymphovascular invasion are the group entity that could benefit from radiotherapy At present a new clinical trial ARTIST II aiming at advanced gastric cancer with positive lymph node metastasis has been launched China is one of the countries with the highest incidence of gastric cancer sand nearly 80 of patients are diagnosed with advanced stage So its necessary to conduct the clinical research on this issue
This Enriched-CRT 2017 trial is a prospective multicenter trial for adjuvant chemoradiotherapy CRT and chemotherapy CT in radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion The primary purpose of this study is to evaluate the 3-year overall survival OS and the second purpose is to evaluate 3-year disease free survival DFS and determine the safety of CRT compared with CT in the patients enrolled in this study
Local recurrence is considered as the most common way of recurrence for advanced gastric cancer as well as an important factor for poor prognosis Radiotherapy is a widely used technique in Western countries and has been identified to have a significant role in decreasing local recurrence rate in breast cancer and colon rectal cancer At this moment several randomized controlled trials have been conducted to identify the role of radiotherapy in advanced gastric cancer Although the results from Europe INT-0116 Dutch CRITICS and Korea ARTIST did not find that radiotherapy could improve the overall survival of enrolled patients the sub-group analyses demonstrated that radiotherapy could improve the disease-free survival in patients with lymph node metastasis We also found that adjuvant chemoradiotherapy could improve the survival of patients with lymph node metastasis or lymphovascular Invasion based on a large cohort study from National Cancer Database
Therefore our hypothesis is that advanced gastric cancer patients with lymph node metastasis or lymphovascular invasion are the group entity that could benefit from radiotherapy At present a new clinical trial ARTIST II aiming at advanced gastric cancer with positive lymph node metastasis has been launched China is one of the countries with the highest incidence of gastric cancer sand nearly 80 of patients are diagnosed with advanced stage So its necessary to conduct the clinical research on this issue
This Enriched-CRT 2017 trial is a prospective multicenter trial for adjuvant chemoradiotherapy CRT and chemotherapy CT in radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion The primary purpose of this study is to evaluate the 3-year overall survival OS and the second purpose is to evaluate 3-year disease free survival DFS and determine the safety of CRT compared with CT in the patients enrolled in this study
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