Gastric Cancer Clinical Trial
Official title:
The Effect of Preoperative Docetaxel, Cisplatin and Capecitabine on Serum RUNX3 Hypermethylation Status in Patients With Gastric and Lower Oesophagus Adenocarcinoma.
- To assess the radiological response, curative resection rate of preoperative
docetaxel/cisplatin/capecitabine(DCX).
- To correlate treatment response with serum RUNX3 promoter hypermethylation.
- To determine the toxicities of preoperative DCX
- To determine the time to progression/overall survival of preoperative DCX
Background:
Pre-operative chemotherapy down size and down stage tumours prior to surgery and improves
treatment outcome. However, current chemotherapy regime requires long terrn venous access
for protracted chemotherapy infusion. Despite encouraging response rate, there are still a
substantial number who did not achieve curative resection after pre-operative chemotherapy.
Hence there is a need to develop 1) a more convenient and effective regimen and 2) a
surrogate for treatment response so that the non-responder can be identified early.
Specific aims:
To assess the radiological response, curative resection rate of preoperative
docetaxel/cisplatin and capecitabine in patients with Stage II & III gastric or lower
oesophageal adenocarcinoma and to correlate treatment response with serum RUNX3 methylation
status.
Hypotheses:
We hypothesize that the proposed preoperative regimen is effective in gastric cancer and can
be safely delivered. In addition, RUNX3 promoter hypermethylation status can be a surrogate
for treatment response.
Methodology:
This is a phase II study design to assess the response and tolerability of preoperative
docetaxel, cisplatin and capecitabine in patients with operable gastric cancer. Simon's
two-stage design is used to calculate the sample size for this Phase II trial, using two
levels of response rate, P0 (20%) and P1 (50%). Accordingly, 20 patients is required for
this study; 8 patients will be accrued for the first stage followed by 12 more patients when
three or more responses are observed during the first stage. The alpha level of the design
is 0.04 and power is 0.86. Serum measurement of tumour's RUNX3 promoter hypermethylation
will be performed prior to each treatment cycle to evaluate its role as a biomarker for
treatment response.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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