Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Gastric Cancer

Thank you

Trial Information

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


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


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.


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.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed adenocarcinoma of the
stomach or lower third of the oesophagusthat considered to be stage II (through the
submucosa) or higher, with no evidence of distant metastases, or locally advanced
inoperable disease, as evaluated by computed tomography, chest radiography,
ultrasonography, or laparoscopy.

- Patients must have evaluable or measurable disease, defined as at least one lesion
that can be accurately measured in at least one dimension (longest diameter to be
recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT

- Age >= 18 years. Because no dosing or adverse event data are currently available on
the use of DCX in patients <18 years of age, children are excluded from this study.

- ECOG performance status <= 1 (see Appendix A).

- Patients must have normal organ and marrow function as defined below:

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

- The effects of DCX on the developing human fetus at the recommended therapeutic dose
are unknown. For this reason, women of child-bearing potential and men must agree to
use adequate contraception (hormonal or barrier method of birth control; abstinence)
prior to study entry and for the duration of study participation. Should a woman
become pregnant or suspect she is pregnant while participating in this study, she
should inform her treating physician immediately.

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Patients who have had prior chemotherapy or radiotherapy.

- Patients may not be receiving any other investigational agents.

- Patients with stage I or IV cancer of the stomach or lower oesophagus.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to docetacel, cisplatin or capecitabine.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women are excluded from this study because agents use in the study may cause
fetal harm.

- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with docetaxel. In addition, these
patients are at increased risk of lethal infections when treated with
marrow-suppressive therapy.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of Response and Progression using RECIST Criteria

Outcome Description:

Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, x-ray) or as >10 mm with spiral CT scan.

Outcome Time Frame:

baseline and after two cycles of chemotherapy

Safety Issue:


Principal Investigator

Wei Peng Yong, MRCP, MB ChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

May 2007

Completion Date:

May 2014

Related Keywords:

  • Gastric Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms