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Brief Title: A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Official Title: A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Study ID: NCT00123318
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 epirubicin, cisplatin, and 5-fluorouracil (ECF) chemotherapy together with radiotherapy.
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 and there remains debate regarding the optimal chemotherapy regimen and the optimal method of radiotherapy delivery. This study will evaluate a new regimen of adjuvant chemoradiotherapy for gastric cancer that employs ECF chemotherapy as the systemic component given before and after concurrent chemoradiation with continuous infusional 5-fluorouracil. Patients receive one cycle of ECF, followed 28 days later by chemoradiotherapy to a radiation dose of 45 Gy in 25 fractions over 5 weeks, and then one month later two further cycles of ECF are given. All patients are treated using multiple-field conformal radiation techniques. The specific objectives of the study are: * To detail the acute toxicity associated with this treatment. * To determine the feasibility of the proposed concurrent chemoradiation regimen. * To determine the feasibility of a standardized technique for radiation treatment planning and delivery. The study will help to develop a common approach to the adjuvant treatment of gastric cancer, which is required before initiating further clinical trials in gastric cancer.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Liverpool Hospital, Liverpool, New South Wales, Australia
Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Nepean Cancer Care Centre, Penrith, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
Royal North Shore Hospital, Sydney, New South Wales, Australia
Westmead Hospital, Sydney, New South Wales, Australia
Mater QRI, Brisbane, Queensland, Australia
Royal Brisbane Hospital, Herston, Queensland, Australia
East Coast Cancer Centre, Tugun, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Launceston General Hospital, Launceston, Tasmania, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Andrew Love Cancer Care Centre, Geelong Hospital, Geelong, Victoria, Australia
Austin Health, Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Alfred Hospital, Prahran, Victoria, Australia
Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
Christchurch Hospital, Christchurch, , New Zealand
Name: Trevor Leong
Affiliation: Peter MacCallum Cancer Centre, Australia
Role: STUDY_CHAIR