Gastric Cancer Clinical Trial
Official title:
A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial of Chemotherapy Alone Versus D2 Gastrectomy and Metastasectomy Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor
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
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.
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