Gastric Cancer
Conditions
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.
Interventions
PROCEDUREGastrectomy
In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
DRUGoxaliplatin
oxaliplatin 100 mg/m2
DRUGS1
S1 40mg/m2
DRUGDocetaxel
docetaxel 40 mg/m2
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | through study completion, an average of 2 year |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival | through study completion, an average of 1 year |
Other
| Measure | Time frame |
|---|---|
| response rate | through study completion, an average of 24 weeks |
| adverse events | through study completion, an average of 1 year |
Countries
China
Outcome results
None listed