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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450203 |
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cisplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving combination chemotherapy together with bevacizumab works compared with combination chemotherapy alone in treating patients with previously untreated stomach cancer or gastroesophageal junction cancer that can be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: bevacizumab Drug: capecitabine Drug: cisplatin Drug: epirubicin hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Randomized Controlled Phase II/III Trial of Peri-Operative Chemotherapy With or Without Bevacizumab in Operable Adenocarcinoma of the Stomach and Gastro Oesophageal Junction |
Estimated Enrollment: | 1100 |
Study Start Date: | October 2007 |
OBJECTIVES:
Primary
OUTLINE: This is a multicenter, randomized, open-label, controlled study. Patients are randomized to 1 of 2 treatment arms.
Patients undergo surgery 5-6 weeks after completion of chemotherapy. Patients then receive 3 additional courses of chemotherapy beginning 6-10 weeks after surgery.
Patients undergo surgery 5-8 weeks after completion of chemotherapy. Patients then receive 3 additional courses of chemotherapy and bevacizumab beginning 6-10 weeks after surgery. Patients then receive maintenance therapy comprising bevacizumab IV over 30-90 minutes on day 1. Maintenance therapy repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, during treatment, and during the follow-up period.
After completion of study treatment, patients are followed at 9, 18, and 27 weeks after the start of course 4, 1 year post surgery, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,100 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed gastric or type III gastroesophageal junction adenocarcinoma
PATIENT CHARACTERISTICS:
No prior or concurrent significant medical conditions, including any of the following:
Cardiovascular disease, including the following:
Recent history of any active gastrointestinal inflammatory condition (e.g., peptic ulcer disease, diverticulitis, or inflammatory bowel disease)
No known allergy to any of the following:
PRIOR CONCURRENT THERAPY:
No chronic corticosteroids (≥ 10 mg/day methylprednisolone equivalent)
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Hugo Ford, MD 44-1223-245-151 | |
Aintree University Hospital | Recruiting |
Liverpool, England, United Kingdom, L9 7AL | |
Contact: David Smith, MD 44-151-525-5980 | |
Berkshire Cancer Centre at Royal Berkshire Hospital | Recruiting |
Reading, England, United Kingdom, RG1 5AN | |
Contact: Joss Adams, MD 44-118-322-7878 | |
Bradford Royal Infirmary | Recruiting |
Bradford, England, United Kingdom, BD9 6RJ | |
Contact: Sue Cheeseman, MD 44-1274-542-200 | |
Bristol Haematology and Oncology Centre | Recruiting |
Bristol, England, United Kingdom, BS2 8ED | |
Contact: Stephen J. Falk, MD 44-117-928-3074 stephen.falk@ubht.nhs.uk | |
Christie Hospital | Recruiting |
Manchester, England, United Kingdom, M20 4BX | |
Contact: Was Mansoor, MD 44-845-226-3000 | |
Clatterbridge Centre for Oncology | Recruiting |
Merseyside, England, United Kingdom, CH63 4JY | |
Contact: David Smith, MD 44-151-334-1155 david.smith@ccotrust.nhs.uk | |
Mid Kent Oncology Centre at Maidstone Hospital | Recruiting |
Maidstone, England, United Kingdom, ME16 9QQ | |
Contact: Justin Waters, MD 44-1622-729-000 | |
Derriford Hospital | Recruiting |
Plymouth, England, United Kingdom, PL6 8DH | |
Contact: Sarah Pascoe, MD 44-175-277-7111 | |
Doncaster Royal Infirmary | Recruiting |
Doncaster, England, United Kingdom, DN2 5LT | |
Contact: Jonathan Wadsley 44-1302-366-666 | |
Huddersfield Royal Infirmary | Recruiting |
Huddersfield, West Yorks, England, United Kingdom, HD3 3EA | |
Contact: Jo Dent 44-1484-342-000 | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: Matthew T. Seymour, MA, MD, FRCP 44-113-206-6400 | |
Lincoln County Hospital | Recruiting |
Lincoln, England, United Kingdom, LN2 5QY | |
Contact: Zuzana Stokes 44-1522-512-512 | |
Cumberland Infirmary | Recruiting |
Carlisle, England, United Kingdom, CA2 7HY | |
Contact: Jonathan J. Nicoll, MD 44-122-881-4688 jonathan.nicoll@ncumbria-acute.nhs.uk | |
Northern Centre for Cancer Treatment at Newcastle General Hospital | Recruiting |
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
Contact: Fareeda Coxon, MD 44-191-256-3551 fareeda.coxon@nuth.nhs.uk | |
Poole Hospital NHS Trust | Recruiting |
Poole Dorset, England, United Kingdom, BH15 2JB | |
Contact: Richard Osborne, MD, FRCP 44-1-202-448-265 | |
Rochdale Infirmary | Recruiting |
Rochdale, England, United Kingdom, 0L12 0NB | |
Contact: Khurshid Akhtar, MD 44-170-637-7777 | |
Royal Bournemouth Hospital NHS Trust | Recruiting |
Bournemouth, England, United Kingdom, BH7 7DW | |
Contact: Tom Geldart 44-1202-726-088 | |
Salisbury District Hospital | Recruiting |
Salisbury, England, United Kingdom, SP2 8BJ | |
Contact: Tim J. Iveson, MD 44-1722-336-262 ext. 4688 | |
Saint Bartholomew's Hospital | Recruiting |
London, England, United Kingdom, EC1A 7BE | |
Contact: Sarah Slater, MD 44-20-7601-8391 | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: David Cunningham, MD 44-20-8661-3279 david.cunningham@rmh.nhs.uk | |
Southampton General Hospital | Recruiting |
Southampton, England, United Kingdom, SO16 6YD | |
Contact: Tim J. Iveson, MD 44-23-8079-6802 t.iveson@soton.ac.uk | |
St. George's Hospital | Recruiting |
London, England, United Kingdom, SW17 0QT | |
Contact: Tim Benepal, MD 44-208-725-2995 | |
St. Luke's Cancer Centre at Royal Surrey County Hospital | Recruiting |
Guildford, England, United Kingdom, GU2 7XX | |
Contact: Gary W. Middleton 44-1483-570-122 gmiddleton@royalsurrey.nhs.uk | |
St. Mary's Hospital | Recruiting |
London, England, United Kingdom, W2 1NY | |
Contact: Danielle Power, MD 44-20-7886-7690 danielle.power@st-marys.nhs.uk | |
Wexham Park Hospital | Recruiting |
Slough, Berkshire, England, United Kingdom, SL2 4HL | |
Contact: Marcia Hall, MD 44-1753-634-364 marcia.hall@nhs.net.uk | |
United Kingdom, Scotland | |
Aberdeen Royal Infirmary | Recruiting |
Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
Contact: Russell Petty, MD 44-84-5456-6000 | |
United Kingdom, Wales | |
Velindre Cancer Center at Velindre Hospital | Recruiting |
Cardiff, Wales, United Kingdom, CF14 2TL | |
Contact: Tom Crosby, MD 44-29-2031-6292 |
Study Chair: | David Cunningham, MD | Royal Marsden - Surrey |
Study ID Numbers: | CDR0000536013, MRC-ST03, EU-20710, ISRCTN46020948, EUDRACT-2006-000811-12, CTA-00316/0221/001 |
Study First Received: | March 20, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00450203 |
Health Authority: | Unspecified |
adenocarcinoma of the stomach stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer |
Capecitabine Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Stomach cancer Bevacizumab Epirubicin |
Digestive System Diseases Stomach Diseases Cisplatin Stomach Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Antibiotics, Antineoplastic |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |