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Sponsored by: |
National University Hospital, Singapore |
Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00674167 |
Condition | Intervention | Phase |
Gastric Cancer |
Drug: Capecitabine, Cisplatin and Docetaxel |
Phase II |
MedlinePlus related topics: | Cancer Stomach Cancer |
Drug Information available for: | Docetaxel Cisplatin Capecitabine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled |
Official Title: | The Effect of Preoperative Docetaxel, Cisplatin and Capecitabine on Serum RUNX3 Hypermethylation Status in Patients With Gastric and Lower Oesophagus Adenocarcinoma. |
Estimated Enrollment: | 20 |
Study Start Date: | May 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
X leukocytes >= 3,000/mcL X absolute neutrophil count >= 1,500/mcL X platelets >= 100,000/mcL X total bilirubin within normal institutional limits X AST(SGOT)/ALT(SGPT) <= 2.5 X institutional upper limit of normal X creatinine within normal institutional limits
Exclusion Criteria:
Contact: Wei Peng Yong, MRCP, MB ChB | 65-6772-4670 | Wei_Peng_Yong@nuh.com.sg |
Singapore | |||||
National University Hospital | Recruiting | ||||
Singapore, Singapore | |||||
Contact: Wei Peng Yong, MRCP, MB ChB 65-6772-4670 ext 4670 Wei_Peng_Yong@nuh.com.sg | |||||
Principal Investigator: Wei Peng Yong, MRCP, MB ChB |
National University Hospital, Singapore |
Principal Investigator: | Wei Peng Yong, MRCP, MB ChB | National University Hospital, Singapore |
Responsible Party: | National University Hospital ( Yong Wei Peng, Consultant ) |
Study ID Numbers: | GA02/33/06, DSRB Reference Code: B/06/462, HSA No: CTC0700084 |
First Received: | May 5, 2008 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00674167 |
Health Authority: | Singapore: Domain Specific Review Boards |
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