Status: Closed
Activation Date: 2013JUL31
Closing Date: 2021JUL01
Phase: II-III
Description: A Randomized Phase II/III Trial of Preoperative Chemoradiotherapy versus Preoperative Chemotherapy For Resectable Gastric Cancer (TOPGEAR)
Eligibility: Patients with resectable adenocarcinoma of stomach or gastroesophageal junction, Stage IB (T1N1) - IIIC (T3,4 and/or N+ve).
Objective: Primary: Overall Survival Secondary: DSF, toxicity, pCR rate, Surgical R0 Resection rate, , QoL; Economics; A biologic correlate
Participation: Open to member centres
Lay Description: This study will see if the addition of pre-operative chemoradiotherapy prior to surgery to the standard pre-operative chemotherapy, surgery and post-operative chemotherapy improves response rates and overall survival. You may be eligible for this trial if you aged >=18 years and have been diagnosed with esophago-gastric cancer which, in the opinion of your doctor, can be completely removed by surgery. Participants in this trial will be randomly (by chance) allocated to one of two groups. Patients randomised to Group 1 will receive 3-4 cycles or pre-operative chemotherapy. Patients randomised to Group 2 will receive 2-3 cycles of pre-operative chemotherapy, then will have a 2-4 week break before chemoradiotherapy. Surgery for both groups should be performed within 6 weeks of the end of the last pre-op cycle. About 4-10 weeks after surgery, patients will receive 3-4 more cycles of chemotherapy.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | GA1 | 157 | 68 | 26 | 89 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GASTRO-INTESTINAL | GA1 | 157 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GASTRO-INTESTINAL | GA1 | 157 | 80 | 59 | 0 | 0 | 89 | 89 | 0 | 0 |