An observational study in Gastric Cancer, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by Shanghai Zhongshan Hospital · Observational
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.
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 228 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
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Clinical diagnosis of gastric cancer with a single non-curable factor
Exclusion Criteria:
In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
Procedure: Gastrectomy · Drug: oxaliplatin · Drug: S1 · Drug: Docetaxel
Patients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: \<1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and \>1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle.
Drug: oxaliplatin · Drug: S1 · Drug: Docetaxel
In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
oxaliplatin 100 mg/m2
Also known as: Eloxatin
S1 40mg/m2
Also known as: tegafur
docetaxel 40 mg/m2
Also known as: Taxotere
overall survival
Time frame: through study completion, an average of 2 year
progression-free survival
Time frame: through study completion, an average of 1 year
response rate
Time frame: through study completion, an average of 24 weeks
adverse events
Time frame: through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital