Status: Closed
Activation Date: 2017JAN09
Closing Date: 2021FEB03
Phase: III
Description: A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)
Eligibility: Adults with histologically or cytologically confirmed advanced gastro-oesophageal Cancer (AGOC), with measurable metastatic or locally advanced disease, who have failed or were intolerant of 2 lines of prior anti-cancer therapy which have included a platinum & fluoropyrimidine analogue.
Objective: Primary Objective: OS in overall study population and in the Asian sub-population Secondary Objectives: PFS, Objective tumour response rate (PR or CR); Quality of life (QoL); Safety (rates of adverse events)
Participation: Open to member centres
Lay Description: This study will evaluate the effect of a drug called regorafenib for treatment of advanced gastro-oesophageal cancer. You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) gastro-oesophageal cancer which has not responded to treatment. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants will either take regorafenib (Group 1) or a placebo (inactive substance) (Group 2) tablet once per day on days 1-21 of each 28 day cycle. Treatment will continue until disease progression or prohibitive adverse events. Participants will not know whether they are taking regorafenib or the placebo until after the trial is completed. Participants will be followed up every 2-4 weeks in order to evaluate how they are responding to treatment.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | GA3 | 16 | 10 | 5 | 11 |
(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 | GA3 | 16 | 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 | GA3 | 16 | 9 | 0 | 0 | 0 | 9 | 9 | 0 | 0 |