Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT00123318
Eligibility Criteria:
Inclusion Criteria:
All of the following must apply:
* Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction that is:
1. completely resected with negative margins
2. Stage T3,4 and/or N1,2 patients who have undergone a D2 nodal dissection can be entered on the study at the discretion of the treating clinician.
* Age greater than or equal to 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
* Adequate organ function defined as follows:
* Bone marrow: Haemoglobin greater than or equal to 90 g/L; Neutrophil count greater than or equal to 1.5 x 10\^9 /L; Platelet count greater than or equal to 100 x 10\^9 /L
* Hepatic: Serum bilirubin less than or equal to 1.5 x ULN; AST and/or ALT less than or equal to 3.0 x ULN;
* Renal: Serum creatinine less than or equal to 0.150 mmol/L, and calculated creatinine clearance greater than or equal to 50mL/min.
* Adequate oral nutrition (intake greater than or equal to 1500 calories/day). This is to be assessed by a dietician prior to commencing treatment.
* Disease which can be radically treated to 45 Gy with standard fractionation.
* Patient able to be treated with infusional 5-fluorouracil (5-FU) and ECF chemotherapy.
* Written informed consent
Exclusion Criteria:
None of the following must apply:
* Evidence of metastatic disease.
* Prior chemotherapy or radiotherapy
* Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled.
* Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures.
* Cardiac failure (relevant to the use of epirubicin):
* Patients with myocardial infarction within the last 6 months;
* Patients with New York Heart Association class III/IV congestive heart failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00123318
Study Brief:
Protocol Section:
NCT00123318