TOPGEAR: a randomised phase III trial of perioperative ECF chemotherapy versus preoperative chemoradiation plus perioperative ECF chemotherapy for resectable gastric ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2015-07-21

AUTHORS

Trevor Leong, B Mark Smithers, Michael Michael, Val Gebski, Alex Boussioutas, Danielle Miller, John Simes, John Zalcberg, Karin Haustermans, Florian Lordick, Christoph Schuhmacher, Carol Swallow, Gail Darling, Rebecca Wong

ABSTRACT

BackgroundThe optimal management of patients with resectable gastric cancer continues to evolve in Western countries. Following publication of the US Intergroup 0116 and UK Medical Research Council MAGIC trials, there are now two standards of care for adjuvant therapy in resectable gastric cancer, at least in the Western world: postoperative chemoradiotherapy and perioperative epirubicin/cisplatin/fluorouracil (ECF) chemotherapy.We hypothesize that adding chemoradiation to standard perioperative ECF chemotherapy will achieve further survival gains. We also believe there are advantages to administering chemoradiation in the preoperative rather than postoperative setting. In this article, we describe the TOPGEAR trial, which is a randomised phase III trial comparing control arm therapy of perioperative ECF chemotherapy with experimental arm therapy of preoperative chemoradiation plus perioperative ECF chemotherapy.Methods/DesignEligible patients with resectable adenocarcinoma of the stomach or gastroesophageal junction will be randomized to receive either perioperative chemotherapy alone (3 preoperative and 3 postoperative cycles of ECF) or perioperative chemotherapy plus preoperative chemoradiation. In the chemoradiation arm, patients receive 2 cycles of ECF plus chemoradiation prior to surgery, and then following surgery 3 further cycles of ECF are given.The trial is being conducted in two Parts; Part 1 (phase II component) has recruited 120 patients with the aim of assessing feasibility, safety and preliminary efficacy of preoperative chemoradiation. Part 2 (phase III component) will recruit a further 632 patients to provide a total sample size of 752 patients. The primary endpoint of the phase III trial is overall survival. The trial includes quality of life and biological substudies, as well as a health economic evaluation. In addition, the trial incorporates a rigorous quality assurance program that includes real time central review of radiotherapy plans and central review of surgical technique.DiscussionTOPGEAR is an international, intergroup collaboration led by the Australasian Gastro-Intestinal Trials Group (AGITG), in collaboration with the Trans-Tasman Radiation Oncology Group (TROG), European Organisation for Research and Treatment of Cancer (EORTC) and the NCIC Clinical Trials Group. It addresses a globally significant question that will help inform future international standards for clinical practice in resectable gastric cancer.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12609000035224. Registered 30 May 2009 More... »

PAGES

532

Journal

TITLE

BMC Cancer

ISSUE

1

VOLUME

15

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12885-015-1529-x

DOI

http://dx.doi.org/10.1186/s12885-015-1529-x

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1046192944

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26194186


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18 schema:description BackgroundThe optimal management of patients with resectable gastric cancer continues to evolve in Western countries. Following publication of the US Intergroup 0116 and UK Medical Research Council MAGIC trials, there are now two standards of care for adjuvant therapy in resectable gastric cancer, at least in the Western world: postoperative chemoradiotherapy and perioperative epirubicin/cisplatin/fluorouracil (ECF) chemotherapy.We hypothesize that adding chemoradiation to standard perioperative ECF chemotherapy will achieve further survival gains. We also believe there are advantages to administering chemoradiation in the preoperative rather than postoperative setting. In this article, we describe the TOPGEAR trial, which is a randomised phase III trial comparing control arm therapy of perioperative ECF chemotherapy with experimental arm therapy of preoperative chemoradiation plus perioperative ECF chemotherapy.Methods/DesignEligible patients with resectable adenocarcinoma of the stomach or gastroesophageal junction will be randomized to receive either perioperative chemotherapy alone (3 preoperative and 3 postoperative cycles of ECF) or perioperative chemotherapy plus preoperative chemoradiation. In the chemoradiation arm, patients receive 2 cycles of ECF plus chemoradiation prior to surgery, and then following surgery 3 further cycles of ECF are given.The trial is being conducted in two Parts; Part 1 (phase II component) has recruited 120 patients with the aim of assessing feasibility, safety and preliminary efficacy of preoperative chemoradiation. Part 2 (phase III component) will recruit a further 632 patients to provide a total sample size of 752 patients. The primary endpoint of the phase III trial is overall survival. The trial includes quality of life and biological substudies, as well as a health economic evaluation. In addition, the trial incorporates a rigorous quality assurance program that includes real time central review of radiotherapy plans and central review of surgical technique.DiscussionTOPGEAR is an international, intergroup collaboration led by the Australasian Gastro-Intestinal Trials Group (AGITG), in collaboration with the Trans-Tasman Radiation Oncology Group (TROG), European Organisation for Research and Treatment of Cancer (EORTC) and the NCIC Clinical Trials Group. It addresses a globally significant question that will help inform future international standards for clinical practice in resectable gastric cancer.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12609000035224. Registered 30 May 2009
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24 schema:keywords Australasian Gastro-Intestinal Trials Group
25 Clinical Trials Group
26 ECF
27 ECF chemotherapy
28 European Organization
29 III trials
30 Intergroup 0116
31 MAGIC trial
32 NCIC Clinical Trials Group
33 Oncology Group
34 Part 1
35 Part 2
36 Radiation Oncology Group
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54 chemoradiotherapy
55 chemotherapy
56 clinical practice
57 collaboration
58 countries
59 cycle
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61 efficacy
62 endpoint
63 evaluation
64 feasibility
65 fluorouracil chemotherapy
66 further cycles
67 further survival gains
68 future international standards
69 gain
70 gastric cancer
71 gastroesophageal junction
72 group
73 health economic evaluations
74 intergroup collaboration
75 international standards
76 junction
77 life
78 management
79 optimal management
80 organization
81 overall survival
82 part
83 patients
84 perioperative chemotherapy
85 phase III trials
86 plan
87 postoperative chemoradiotherapy
88 postoperative setting
89 practice
90 preliminary efficacy
91 preoperative chemoradiation
92 primary endpoint
93 program
94 publications
95 quality
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97 quality of life
98 questions
99 radiotherapy plans
100 real-time central review
101 research
102 resectable adenocarcinoma
103 resectable gastric cancer
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106 safety
107 sample size
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113 stomach
114 substudy
115 surgery
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117 survival
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119 technique
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121 total sample size
122 treatment
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