Status:
COMPLETED
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
The Royal Australian and New Zealand College of Radiologists
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 epiru...
Detailed Description
It has been shown recently in a study conducted in the USA (INT0116) that postoperative, adjuvant chemoradiotherapy improves survival for patients with gastric cancer. This treatment is relatively new...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00123318
Start Date
February 1 2003
End Date
February 1 2012
Last Update
June 18 2013
Active Locations (19)
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1
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
2
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
3
Nepean Cancer Care Centre
Penrith, New South Wales, Australia, 2751
4
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031