A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

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.

Official Title

Conditions

Gastric Cancer

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Further Details

Primary Outcomes: The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity; The percentage of patients who complete the planned chemoradiation protocol; The percentage of major radiotherapy protocol violationsSecondary Outcomes: Median survival and overall survival at 3 yearsExpected Total Enrollment: 52

Study Start

Study start: June 2003; Expected completion: December 2008

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

Total Enrolment

Contact Details

Australia, New South Wales Westmead Hospital, Sydney, New South Wales, 2145, Australia; Recruiting Jayasingham Jayamoham, MD +61 2 98456499 jjmohan@radonc.wsahs.nsw.gov.au Jayasingham Jayamoham, Principal Investigator Newcastle Mater Misericordiae Hospital, Newcastle, New South Wales, 2298, Australia; Recruiting Chris Wratten, MD +61 (0) 2 4921 1475 mdcwr@alinga.newcastle.edu.au Chris Wratten, Principal Investigator Royal Prince Alfred Hospital, Sydney, New South Wales, 2050, Australia; Recruiting George Hruby, MD +61 (0) 2 95158057 ghruby@email.cs.nsw.gov.au George Hruby, Principal Investigator Royal North Shore Hospital, Sydney, New South Wales, 2069, Australia; Recruiting Graeme Morgan, MD +61 2 99265009 gmorgan1@bigpond.net.au Graeme Morgan, Principal InvestigatorAustralia, Queensland Princess Alexandra Hospital, Brisbane, Queensland, 4102, Australia; Recruiting Jennifer Harvey, MD +61 (0)7 32406798 J.Harvey@mailbox.uq.edu.au Jennifer Harvey, Principal InvestigatorAustralia, Victoria Peter MacCallum Cancer Centre, Melbourne, Victoria, 8006, Australia; Recruiting Trevor Leong, MD +61 3 96561111 Trevor.Leong@petermac.org Trevor Leong, Principal Investigator Austin Health, Melbourne, Victoria, 3081, Australia; Recruiting Daryl Lim Joon, MD + 61 (0) 3 9496 2800 Daryl.LimJoon@austin.org.au Daryl Lim Joon, Principal InvestigatorAustralia, Western Australia Sir Charles Gairdner Hospital, Perth, Western Australia, 6009, Australia; Recruiting Nigel Spry, MD +61 (0) 8 93464900 Nigel.Spry@health.wa.gov.au Nigel Spry, Principal Investigator