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ACTIVE NOT RECRUITING
NCT01924819
PHASE2/PHASE3

Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma

Sponsor: Australasian Gastro-Intestinal Trials Group

View on ClinicalTrials.gov

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

DRUG

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)

RADIATION

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.

PROCEDURE

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