A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
Final analysis will be at 3 years.
Peter MacCallum Cancer Centre, Australia
Australia: Department of Health and Ageing Therapeutic Goods Administration