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Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma
Sponsor: Australasian Gastro-Intestinal Trials Group
Summary
Gastric cancer remains a significant global public health problem. Although in developed countries its incidence has dramatically decreased, on a worldwide scale it is still a leading cause of cancer-related deaths. Surgery is the only potentially curative treatment for gastric cancer. Although the survival rates for patients with early stage disease (stage 1A and 1B) are good, this subgroup of patients constitutes only 20% of those undergoing resection. The majority of patients will have locally advanced or metastatic disease at presentation, which has an extremely poor prognosis. The current five-year survival rate for gastric cancer in Western countries is approximately 20-30%, a figure that has improved little over the past 30 years. The intervention arm in TOPGEAR consists of pre-operative chemotherapy, pre-operative chemoradiotherapy, surgery and post-operative chemotherapy. The control arm consists of pre-operative chemotherapy, surgery and post-operative chemotherapy. The primary objective of TOPGEAR is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving pathological complete response rates in the first instance, and subsequently overall survival, in patients undergoing adequate surgery (D1+ dissection) for resectable gastric cancer.
Official title: A Randomised Phase II/III Trial of Preoperative Chemoradiotherapy Versus Preoperative Chemotherapy for Resectable Gastric Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
574
Start Date
2009-09
Completion Date
2026-12-31
Last Updated
2025-03-04
Healthy Volunteers
No
Conditions
Interventions
Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxel
Epirubicin 50 mg/m2 IV day 1, cisplatin 60 mg/m2 IV day 1, 5-fluorouracil 200 mg/m2/d IV 21 day continuous infusion (ECF chemotherapy). Epirubicin 50 mg/m2 IV day 1, Cisplatin 60 mg/m2 IV day 1, Capecitabine (X = Xeloda) 625mg/m2, bid days 1-21 (ECX chemotherapy) Epirubicin 50mg/m2 IV day 1, Oxaliplatin (O) 130mg/m2 IV day 1, Capecitabine 625mg/m2, bid days 1-21 (EOX chemotherapy) 5-Fluorouracil 2600 mg/m² IV 24 h infusion day 1, Leucovorin (L) 200 mg/m² IV day 1, Oxaliplatin 85 mg/m² IV day 1, Docetaxel (T) 50 mg/m² IV day 1 (FLOT chemotherapy)
Preoperative chemoradiotherapy
Chemotherapy: Continuous infusional 5-fluorouracil 200mg/m2/day, 7 days per week, throughout the entire period of radiotherapy or capecitabine 825 mg/m2, oral tablet twice daily, days 1-5 of each week of radiotherapy (without weekends). Radiotherapy: 45 Gy of radiation in 25 fractions, five days per week for five weeks.
Gastric resection
The acceptable resections are a total gastrectomy, a subtotal gastrectomy, and an esophagogastrectomy (Ivor-Lewis esophagogastrectomy for gastroesophageal junction cancers \[Siewert Type II and Siewert Type III\] invading up to but no more than 2cm of the lower esophagus). The minimum extent of the operation should be a D1+ lymph node dissection but it is recommended that a D2 dissection be performed or a D1+ for gastroesophageal junction cancers requiring an esophagogastrectomy.
Locations (59)
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Chris O Brien Lifehouse
Sydney, New South Wales, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
Nepean Hospital
Sydney, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
St George Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
The Tweed Hospital
Tweed Heads, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Geelong Hospital
Geelong, Victoria, Australia
Austin Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
St Vincent's Hospital
Melbourne, Victoria, Australia
Sunshine Hospital (Western Health)
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
AZ Klina
Brasschaat, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Hospital De Jolimont
La Louvière, Belgium
U.Z Leuven Campus Gasthuisberg
Leuven, Belgium
AZ Damiaan
Ostend, Belgium
AZ Turnhout- Campus Sint Elisabeth
Turnhout, Belgium
Centre Hospitalier Peltzer- La Tourelle
Verviers, Belgium
BCCA - Vancouver Centre
Vancouver, British Columbia, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Grand River Regional Cancer Center, Kitchener
Kitchener, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Ottawa Health Research Institute
Ottawa, Ontario, Canada
Odette Cancer Centre, Sunnybrook Hospital
Toronto, Ontario, Canada
UHN - Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Hospital Notre-Dame
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Charles University Hospital
Hradec Králové, Czechia
Institut Sainte Catherine
Avignon, France
CHRU de Besancon Hopital Jean Minjoz
Besançon, France
Centre Hospitalier de Belfort Montbeliard site du Mittan
Montbéliard, France
Centre Paul Strauss
Strasbourg, France
Klinikum der Universitaet Muenchen - Campus Grosshadern
München, Bavaria, Germany
Rambam Medical Center
Haifa, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Auckland Hospital
Auckland, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital
Hamilton, New Zealand
The Institute of Oncology
Ljubljana, Slovenia
ICO L Hospitalet Hospital Duran i Reynals (Institut Catala D Oncologia)
L'Hospitalet de Llobregat, Barcelona, Spain
Institut Catala d Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
Badalona, Spain
Vall D Hebron University Hospital
Barcelona, Spain
Hospital Clinico Universitario De Valencia
Valencia, Spain