A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Radiotherapy, Chemotherapy, Chemoradiation
Eligibility Criteria
Inclusion Criteria: All of the following must apply: Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction that is: completely resected with negative margins 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
Sites / Locations
- Liverpool Hospital
- Calvary Mater Newcastle
- Nepean Cancer Care Centre
- Prince of Wales Hospital
- Royal Prince Alfred Hospital
- Royal North Shore Hospital
- Westmead Hospital
- Mater QRI
- Royal Brisbane Hospital
- East Coast Cancer Centre
- Princess Alexandra Hospital
- Launceston General Hospital
- Box Hill Hospital
- Andrew Love Cancer Care Centre, Geelong Hospital
- Austin Health
- Peter MacCallum Cancer Centre
- Alfred Hospital
- Sir Charles Gairdner Hospital
- Christchurch Hospital
Arms of the Study
Arm 1
Experimental
1
Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)