NCT01924819 - Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma | Biotech Hunter

Enrollment

574

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions

Gastric Cancer

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.

Trial Locations (59)

2300

AZ Turnhout- Campus Sint Elisabeth, Turnhout

2650

Universitair Ziekenhuis Antwerpen, Edegem

2930

AZ Klina, Brasschaat

3000

U.Z Leuven Campus Gasthuisberg, Leuven

4800

Centre Hospitalier Peltzer- La Tourelle, Verviers

7100

Hospital De Jolimont, La Louvière

8400

AZ Damiaan, Ostend

25030

CHRU de Besancon Hopital Jean Minjoz, Besançon

31096

Rambam Medical Center, Haifa

46010

Hospital Clinico Universitario De Valencia, Valencia

61105

The Institute of Oncology, Ljubljana

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

67085

Centre Paul Strauss, Strasbourg

81377

Klinikum der Universitaet Muenchen - Campus Grosshadern, München

84918

Institut Sainte Catherine, Avignon

Unknown

Calvary Mater Newcastle, Newcastle

Chris O Brien Lifehouse, Sydney

Liverpool Hospital, Sydney

Nepean Hospital, Sydney

Prince of Wales Hospital, Sydney

Royal North Shore Hospital, Sydney

St George Hospital, Sydney

Westmead Hospital, Sydney

The Tweed Hospital, Tweed Heads

Wollongong Hospital, Wollongong

Princess Alexandra Hospital, Brisbane

Flinders Medical Centre, Adelaide

Royal Hobart Hospital, Hobart

Launceston General Hospital, Launceston

Geelong Hospital, Geelong

Austin Hospital, Melbourne

Monash Medical Centre, Melbourne

Peter MacCallum Cancer Centre, Melbourne

St Vincent's Hospital, Melbourne

Sunshine Hospital (Western Health), Melbourne

Sir Charles Gairdner Hospital, Nedlands

BCCA - Vancouver Centre, Vancouver

Cancer Care Manitoba, Winnipeg

Royal Victoria Regional Health Centre, Barrie

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston

Grand River Regional Cancer Center, Kitchener, Kitchener

London Regional Cancer Program, London

Ottawa Health Research Institute, Ottawa

Odette Cancer Centre, Sunnybrook Hospital, Toronto

UHN - Princess Margaret Hospital, Toronto

Hopital Maisonneuve-Rosemont, Montreal

Hospital Notre-Dame, Montreal

Jewish General Hospital, Montreal

Centre hospitalier universitaire de Sherbrooke, Sherbrooke

Allan Blair Cancer Centre, Regina

Saskatoon Cancer Centre, Saskatoon

Auckland Hospital, Auckland

Dunedin Hospital, Dunedin

Waikato Hospital, Hamilton

Institut Catala d Oncologia - ICO Badalona - Hospital Germans Trias i Pujol, Badalona

500 05

Charles University Hospital, Hradec Králové

24 200

Centre Hospitalier de Belfort Montbeliard site du Mittan, Montbéliard

08907

ICO L Hospitalet Hospital Duran i Reynals (Institut Catala D Oncologia), L'Hospitalet de Llobregat

08035

Vall D Hebron University Hospital, Barcelona