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| Sponsored by: |
Royal Marsden NHS Foundation Trust |
|---|---|
| Information provided by: | Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00824785 |
Purpose
To determine whether adding panitumumab, an antibody against the epidermal growth factor receptor (EGFR), to standard chemotherapy with epirubicin, oxaliplatin and capecitabine (EOX), improves the duration of survival of patients with advanced stomach and oesophageal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Oesophago-Gastric Cancer |
Drug: epirubicin, oxaliplatin, capecitabine, panitumumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | REAL 3 : A Randomised Open-Labelled Multicentre Trial of the Efficacy of Epirubicin, Oxaliplatin and Capecitabine (EOX) With or Without Panitumumab in Previously Untreated Advanced Oesophago-Gastric Cancer |
| Estimated Enrollment: | 730 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm A EOX: Active Comparator
EOX chemotherapy (epirubicin, oxaliplatin an capecitabine)
|
Drug: epirubicin, oxaliplatin, capecitabine, panitumumab
EOX chemotherapy will last 21 days and consist of the following: epirubicin 50mg/m(2) IV on day 1 oxaliplatin 130mg/m(2) IV on day 1 with hydration capecitabine 1250mg/m(2)/day PO in two divided doses continuously from days 1-21 (Arm A) capecitabine 1000mg/m(2)/day PO in two divided doses continuously from days 1-21 (Arm B) panitumumab -9mg/kg every 21 days |
|
Arm B EOX + panitumumab.: Active Comparator
Chemotherapy with the addition of panitumumab 9mg/kg every 21 days
|
Drug: epirubicin, oxaliplatin, capecitabine, panitumumab
EOX chemotherapy will last 21 days and consist of the following: epirubicin 50mg/m(2) IV on day 1 oxaliplatin 130mg/m(2) IV on day 1 with hydration capecitabine 1250mg/m(2)/day PO in two divided doses continuously from days 1-21 (Arm A) capecitabine 1000mg/m(2)/day PO in two divided doses continuously from days 1-21 (Arm B) panitumumab -9mg/kg every 21 days |
Multicentre phase III, open labelled, randomised controlled trial. Randomisation will be 1:1 Arm A EOX and Arm B EOX + panitumumab. There will be a pilot phase II study of which the first 200 patients will be randomised and the primary endpoint for interim analysis will be when these patients have completed 6 months follow-up
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Prof Cunningham | 020 8661 3165 | david.cunningham@rmh.nhs.uk |
| Contact: Leonora Conneely | 020 8661 3807 | Leonora.conneely@rmh.nhs.uk |
| United Kingdom, Surrey | |
| Royal Marsden NHS Foundation Trust | Recruiting |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Contact: Prof Cunningham 020 8661 3165 david.cunningham@rmh.nhs.uk | |
| Contact: Leonora Conneely 020 8661 3807 leonora.conneely@rmh.nhs.uk | |
| Principal Investigator: Prof Cunningham | |
| Principal Investigator: | Prof Cunningham, David | Royal Marsden NHS Foundation Trust |
More Information
| Responsible Party: | Royal Marsden NHS Foundation Trust ( Prof David Cunningham ) |
| Study ID Numbers: | CCR3024 |
| Study First Received: | January 16, 2009 |
| Last Updated: | January 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00824785 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee |
|
epirubicin oxaliplatin capecitabine panitumumab |
|
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Epirubicin Anti-Bacterial Agents Oxaliplatin |
Digestive System Diseases Stomach Diseases Esophageal Disorder Stomach Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Stomach Cancer |
|
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Antibiotics, Antineoplastic Epirubicin Pharmacologic Actions |
Neoplasms Oxaliplatin Digestive System Diseases Neoplasms by Site Stomach Diseases Therapeutic Uses Stomach Neoplasms Gastrointestinal Neoplasms Esophageal Diseases |
