To Observe the Efficacy and Safety by Comparing Chemotherapy(Docetaxel, Oxaliplatin Plus S1 ) Followed With Radical Resection Versus Chemotherapy Alone in Advanced Gastric Cancer With Single Non-curable Factor.

Gastric Cancer Clinical Trial

Official title:

Gastrectomy Plus Chemotherapy Versus Chemotherapy Alone for Advanced Gastric Cancer With a Single Non-curable Factor

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03001726
• Other study ID #: NEO-REGATTA
• Status: Enrolling by invitation
• Start date: January 2017
• Est. completion date: December 2023

Study information

• Verified date: December 2016
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators assessed the effectiveness of conversional gastrectomy compared with chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.

Description:

Palliative chemotherapy is still the standard of care for incurable advanced gastric cancer. Several retrospective, single institutional studies have shown that the addition of gastrectomy to chemotherapy might improve patient survival among patients with metastatic gastric cancer with a single non-curable factor. However, REGATTA trial, a phase 3, randomized controlled trial, 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, five patients initially assigned to chemotherapy alone in the study had got survival benefit form gastrectomy with curative intent because of complete disappear of all non-curable factors during chemotherapy. This finding raised the question as to conversional radical surgery following upfront chemotherapy could be a possible treatment option. We assessed the effectiveness of conversional radical surgery following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 228
• Est. completion date: December 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of gastric cancer with a single non-curable factor
• A single non-curable factor was defined as hepatic metastasis (H1; two to four lesions of maximum diameter =5 cm and minimum diameter =1 cm); peritoneal metastasis (P1) in the diaphragm or peritoneum caudal to the transverse colon without massive ascites or intestinal obstruction; positive cytology (CY1) when the cancer cells were found in the peritoneal washing; para-aortic lymph node (PAN) metastasis above the coeliac axis or below the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter =1 cm), or both; or ovary implant metastasis for one site or two.

Exclusion Criteria:

• Patients who can have radical resection.
• Patietns who have more than one metastasis.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Gastrectomy
In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.

Drug:
• oxaliplatin
oxaliplatin 100 mg/m2
• S1
S1 40mg/m2
• Docetaxel
docetaxel 40 mg/m2

Locations

Country	Name	City	State
China	Zhongshan hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	response rate		through study completion, an average of 24 weeks
Other	adverse events		through study completion, an average of 1 year
Primary	overall survival		through study completion, an average of 2 year
Secondary	progression-free survival		through study completion, an average of 1 year