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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
50mg/m2 IV day 1
60mg/m2 IV day 1
5-FU 200mg/m2/d IV 21 day continuous infusion Cont. infusional 5-FU 225mg/m2/day, 7 days/wk throughout entire period RT via CADD pump through PICC line
Liverpool Hospital
Liverpool, New South Wales, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
Time frame: Final analysis will be at 3 years.
The percentage of patients who complete the planned chemoradiation protocol
Time frame: Final analysis will be at 3 years.
The percentage of major radiotherapy protocol violations
Time frame: Final analysis will be at 3 years.
Median survival and overall survival at 3 years
Time frame: 3 years
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45Gy 25 Fractions, 5 days/week for 5 weeks
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
...and 9 more locations