A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the side-effects and effectiveness of a new type of chemoradiotherapy treatment for patients who have had surgery for stomach cancer. The treatment uses epirubicin, cisplatin, and 5-fluorouracil (ECF) chemotherapy together with radiotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trans Tasman Radiation Oncology Group; Trans-Tasman Radiation Oncology Group (TROG)
• Collaborator: The Royal Australian and New Zealand College of Radiologists
• Treatments: Cisplatin; Epirubicin; Fluorouracil

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