Clinical trial NCT03001726: 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.
Official title: Gastrectomy Plus Chemotherapy Versus Chemotherapy Alone for Advanced Gastric Cancer With a Single Non-curable Factor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical diagnosis of gastric cancer with a single non-curable factor

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall survival
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: progression-free survival
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: response rate
timeFrame: through study completion, an average of 24 weeks
measure: adverse events
timeFrame: through study completion, an average of 1 year
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital
state: Shanghai
Study officials:
affiliation: Zhongshan Hopital
name: Tianshu Liu, Physician
role: PRINCIPAL_INVESTIGATOR
References: