Ignite Creation Date:
2024-05-06 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03399253
Status:
RECRUITING
Last Update Posted:
2018-01-16
First Post:
2018-01-08
Brief Title:
Chemotherapy Alone Versus Surgery Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A ProspectiveMulticentralOpen-labelRandomizedControlledPhase III Clinical Trial of Chemotherapy Alone Versus D2 Gastrectomy and Metastasectomy Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor
Status:
RECRUITING
Status Verified Date:
2018-01
Last Known Status:
None
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:
Our study aims to compare the efficacy and safety of Chemotherapy Alone Versus D2 distal gastrectomy and metastasectomy plus Chemotherapy for gastric cancer GC with one non-curable Factor
Detailed Description:
Gastric cancer is the fourth most common malignancy worldwide and the second leading cause of cancer-related deaths with the highest mortality rates reported in East Asia including China Many patients are diagnosed at an advanced stage of gastric cancer because of late onset and nonspecific symptoms The prognosis of patients with advanced gastric cancer with non-curable factors such as hepatic peritoneal or distant lymph node metastases is poor Chemotherapy is the standard of care for these patients Palliative resection or bypass surgery is generally indicated in the presence of major symptoms such as bleeding or obstruction for incurable advanced gastric cancer The usefulness of gastrectomy and metastasectomy is still unclear
The REGATTA trial is the first clinical trial to explore the significance of surgery for incurable advanced gastric cancer However it concluded an opposite conclusion that gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor Interestingly there was a significant interaction between treatment effect and tumor location in subgroup analyses of overall survival Gastrectomy plus chemotherapy was associated with significantly worse overall survival in patients with upper-third tumors for less chemotherapy cycles This finding raises the question whether inclusion criteria were restricted to the patients with lower-third tumor findings of study might have been positive So we raise this new trail to assess the significance of Gastrectomy and Metastasectomy for Distal Gastric Cancer With One Non-curable Factor
The REGATTA trial is the first clinical trial to explore the significance of surgery for incurable advanced gastric cancer However it concluded an opposite conclusion that gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor Interestingly there was a significant interaction between treatment effect and tumor location in subgroup analyses of overall survival Gastrectomy plus chemotherapy was associated with significantly worse overall survival in patients with upper-third tumors for less chemotherapy cycles This finding raises the question whether inclusion criteria were restricted to the patients with lower-third tumor findings of study might have been positive So we raise this new trail to assess the significance of Gastrectomy and Metastasectomy for Distal Gastric Cancer With One Non-curable Factor
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