NCT00674167

The Effect of Preoperative Docetaxel, Cisplatin and Capecitabine on Serum RUNX3 Hypermethylation Status in Patients With Gastric and Lower Oesophagus Adenocarcinoma

The Effect of Preoperative Docetaxel, Cisplatin and Capecitabine on Serum RUNX3 Hypermethylation Status in Patients With Gastric and Lower Oesophagus Adenocarcinoma.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* 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

Detailed description

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Three cycles of chemotherapy will be administered before surgery with docetaxel at 30 mg/m² on day 1 and 8 in a 21 day treatment cycles.
DRUG	Cisplatin	Three cycles of chemotherapy will be administered before surgery with cisplatin at 30 mg/m² on day 1 and 8 in a 21 day treatment cycle.
DRUG	Capecitabine	Three cycles of chemotherapy will be administered before surgery with capecitabine at 750 mg/m² twice daily from day 1 to 14 in a 21 day treatment cycle.

Timeline

• Start date: 2007-05-01
• Primary completion: 2015-12-01
• Completion: 2017-12-01
• First posted: 2008-05-07
• Last updated: 2015-06-12

Locations

1 site across 1 country: Singapore