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A randomised phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer (Other IDs: TROG 08.08, AG0407GR).
Australasian Gastro-Intestinal Trials Group (AGITG)
The main treatment for stomach cancer is surgery. However, even with surgery there is still a risk that the cancer may come back if no further treatment is given. Over the last 5 years, 2 large international studies have shown that giving additional treatment with radiotherapy and chemotherapy may improve the chances of curing patients with stomach cancer. Firstly, a large British study called MAGIC has shown that giving chemotherapy BEFORE and AFTER surgery is better than just surgery alone. Secondly, a large US study called INT0116 has shown that giving combined chemotherapy and radiotherapy together (chemoradiation) AFTER surgery is better than surgery alone.
The purpose of this study is to compare these 2 treatments to determine which is better. Unlike in the US study, in this study we will be giving chemoradiation BEFORE surgery (preoperative treatment), rather than AFTER surgery (postoperative treatment). This is because we know from studies in other types of cancers that preoperative treatment is better than postoperative treatment. In addition, preoperative treatment also produces fewer side effects so that patients are more likely to complete the planned treatment.
The main aim of this study is therefore to determine if preoperative chemoradiation is more effective than preoperative chemotherapy alone for patients with localised stomach cancer who are going to be treated with surgery. We will also be looking at the side effects of the two treatment combinations.