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Spots Global Cancer Trial Database for A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

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Trial Identification

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

Conditions

Gastric Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Trevor Leong

Affiliation: Peter MacCallum Cancer Centre, Australia

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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