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ST03
A Randomised Phase II/III Trial of Peri-Operative Chemotherapy With or Without Bevacizumab in Operable Oesophagogastric Adenocarcinoma and A Feasibility Study Evaluating Lapatinib in HER-2 Positive Oesophagogastric Adenocarcinomas and (in Selected Centres) MRI and PET/CT Sub-studies
Sponsor study identifier
Secondary identifiers
OTHER · MRC
OTHER · ISRCTN
EUDRACT_NUMBER
OTHER · CTA
interventional
1,103
1 country
41
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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, and small molecule tyrosine kinase inhibitors, such as lapatinib, 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. Lapatinib targets a specific growth receptor, HER-2. Chemotherapy together with bevacizumab or lapatinib, in HER-2 positive tumours, 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, gastroesophageal junction cancer or lower oesophageal cancer that can be removed by surgery. The feasibility study is studying the safety of adding lapatinib to chemotherapy in patients with HER-2 positive previously untreated stomach cancer, gastroesophageal junction cancer or lower oesophageal cancer that can be removed by surgery. The feasibility study will also assess the feasibility of timely HER-2 testing and estimate the HER-2 positivity rate in this patient population.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 20, 2007
Actual (reported)March 22, 2007
Actual (reported)October 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Safety
at the end of phase II and phase III
Efficacy
end of trial
Overall survival
end of trial
Feasibility
end of trial
Treatment-related morbidity
end of trial
Response rates to pre-operative treatment
at phase II review and at end of trial
Surgical resection rates
end of trial
Disease-free survival
end of trial
ECX + Bevacizumab
ECX chemotherapy
7.5mg/kg IV Day 1 of each 21 cycle of chemotherapy (6 cycles) plus day 1 of each maintenance dose every 21 days for 6 doses.
dose banded as based on patient BSA. Oral dose given twice a day during each 21 day cycle of chemotherapy (6 cycles in total)
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW, United Kingdom
Bradford Royal Infirmary
Bradford, England, BD9 6RJ, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED, United Kingdom
Okines AF, Langley RE, Thompson LC, Stenning SP, Stevenson L, Falk S, Seymour M, Coxon F, Middleton GW, Smith D, Evans L, Slater S, Waters J, Ford D, Hall M, Iveson TJ, Petty RD, Plummer C, Allum WH, Blazeby JM, Griffin M, Cunningham D. Bevacizumab with peri-operative epirubicin, cisplatin and capecitabine (ECX) in localised gastro-oesophageal adenocarcinoma: a safety report. Ann Oncol. 2013 Mar;24(3):702-9. doi: 10.1093/annonc/mds533. Epub 2012 Oct 28.
Allum WH, Smyth EC, Blazeby JM, Grabsch HI, Griffin SM, Rowley S, Cafferty FH, Langley RE, Cunningham D. Quality assurance of surgery in the randomized ST03 trial of perioperative chemotherapy in carcinoma of the stomach and gastro-oesophageal junction. Br J Surg. 2019 Aug;106(9):1204-1215. doi: 10.1002/bjs.11184. Epub 2019 Jul 3.
David Cunningham, MD
Royal Marsden NHS Foundation Trust
First Submitted
March 20, 2007
First Posted
March 22, 2007
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2017
ECX + Lapatinib
60mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)
50mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)
3 cycles of ECX chemotherapy post operatively
Surgery undertaken after 3 cycles of pre-operative chemotherapy. Followed by 3 cycles of chemotherapy.
3 cycles of pre-operative ECX chemotherapy.
1250mg/day Day 1-21 of each cycle of chemotherapy (6 cycles) plus day 1-21 of each maintenance course every 21 days for 6 doses.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ, United Kingdom
Cumberland Infirmary
Carlisle, England, CA2 7HY, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, DN2 5LT, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF, United Kingdom
Lincoln County Hospital
Lincoln, England, LN2 5QY, United Kingdom
Aintree University Hospital
Liverpool, England, L9 7AL, United Kingdom
Saint Bartholomew's Hospital
London, England, EC1A 7BE, United Kingdom
St. George's Hospital
London, England, SW17 0QT, United Kingdom
St. Mary's Hospital
London, England, W2 1NY, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, ME16 9QQ, United Kingdom
Christie Hospital
Manchester, England, M20 4BX, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE, United Kingdom
Derriford Hospital
Plymouth, England, PL6 8DH, United Kingdom
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, RG1 5AN, United Kingdom
Rochdale Infirmary
Rochdale, England, 0L12 0NB, United Kingdom
Salisbury District Hospital
Salisbury, England, SP2 8BJ, United Kingdom
Wexham Park Hospital
Slough, Berkshire, England, SL2 4HL, United Kingdom
Southampton General Hospital
Southampton, England, SO16 6YD, United Kingdom
Royal Marsden - Surrey
Sutton, England, SM2 5PT, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Castle Hill Hospital
Cottingham, United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
St James Hospital
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Queens Hospital
Romford, United Kingdom
Weston Park
Sheffield, United Kingdom
Great Western Hospital
Swindon, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
Cunningham D, Stenning SP, Smyth EC, Okines AF, Allum WH, Rowley S, Stevenson L, Grabsch HI, Alderson D, Crosby T, Griffin SM, Mansoor W, Coxon FY, Falk SJ, Darby S, Sumpter KA, Blazeby JM, Langley RE. Peri-operative chemotherapy with or without bevacizumab in operable oesophagogastric adenocarcinoma (UK Medical Research Council ST03): primary analysis results of a multicentre, open-label, randomised phase 2-3 trial. Lancet Oncol. 2017 Mar;18(3):357-370. doi: 10.1016/S1470-2045(17)30043-8. Epub 2017 Feb 3.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 1, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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