ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer
NCT ID: NCT01041404
Last Updated: 2014-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
584 participants
INTERVENTIONAL
2005-09-30
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trastuzumab, Fluoropyrimidine, Cisplatin
Participants received an initial loading dose of 8 milligrams per kilogram (mg/kg) trastuzumab i.v. on Day 1 of cycle, followed by 6 mg/kg i.v. every 3 weeks until disease progression; 800 mg/m2 fluorouracil i.v. on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 cisplatin i.v. on Day 1 of cycle every 3 weeks for 6 cycles; and 1000 mg/m2 capecitabine p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
Trastuzumab
Initial loading dose 8 mg/kg i.v. infusion on Day 1 of cycle, followed by 6 mg/kg i.v. infusion every 3 weeks until disease progression
Fluorouracil
800 mg/m2 i.v. infusion on Days 1 through 5 of cycle every 3 weeks for 6 cycles
Cisplatin
80 mg/m2 i.v. infusion on Day 1 of cycle every 3 weeks for 6 cycles
Capecitabine
1000 mg/m2 p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles
Fluoropyrimidine, Cisplatin
Participants received 800 milligrams per square meter (mg/m2) fluorouracil intravenous (i.v.) on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 cisplatin i.v. on Day 1 of cycle every 3 weeks for 6 cycles; and 1000 mg/m2 capecitabine orally (p.o.) twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
Fluorouracil
800 mg/m2 i.v. infusion on Days 1 through 5 of cycle every 3 weeks for 6 cycles
Cisplatin
80 mg/m2 i.v. infusion on Day 1 of cycle every 3 weeks for 6 cycles
Capecitabine
1000 mg/m2 p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles
Interventions
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Trastuzumab
Initial loading dose 8 mg/kg i.v. infusion on Day 1 of cycle, followed by 6 mg/kg i.v. infusion every 3 weeks until disease progression
Fluorouracil
800 mg/m2 i.v. infusion on Days 1 through 5 of cycle every 3 weeks for 6 cycles
Cisplatin
80 mg/m2 i.v. infusion on Day 1 of cycle every 3 weeks for 6 cycles
Capecitabine
1000 mg/m2 p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction
* Adenocarcinoma
* HER2-positive tumors
Exclusion Criteria
* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome
* History of cardiac disease
* Dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy
18 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Adelaide, , Australia
Kurralta Park, , Australia
Melbourne, , Australia
Milton, , Australia
Perth, , Australia
Sydney, , Australia
Leuven, , Belgium
Barretos, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Guangdong, , China
Guangzhou, , China
Jiangsu, , China
Nanjing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Suzhou, , China
Wuhan, , China
San José, , Costa Rica
San José, , Costa Rica
Herlev, , Denmark
Odense, , Denmark
Tampere, , Finland
Brest, , France
Caen, , France
Colmar, , France
Lille, , France
Marseille, , France
Reims, , France
Rouen, , France
Strasbourg, , France
Heidelberg, , Germany
Mainz, , Germany
München, , Germany
Trier, , Germany
Witten, , Germany
Guatemala City, , Guatemala
Hyderabad, , India
Kochi, , India
Mumbai, , India
New Delhi, , India
Ancona, , Italy
Florence, , Italy
Napoli, , Italy
Parma, , Italy
Roma, , Italy
Udine, , Italy
Aichi, , Japan
Chiba, , Japan
Ehime, , Japan
Fukuoka, , Japan
Hyōgo, , Japan
Nagano, , Japan
Osaka, , Japan
Osaka, , Japan
Saitama, , Japan
Saitama, , Japan
Shizuoka, , Japan
Tochigi, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Yamagata, , Japan
Guadalajara, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mérida, , Mexico
Monterrey, , Mexico
Panama City, , Panama
Callao, , Peru
Lima, , Peru
Lima, , Peru
Braga, , Portugal
Coimbra, , Portugal
Faro, , Portugal
Guimarães, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Porto, , Portugal
Porto, , Portugal
Chelyabinsk, , Russia
Ivanovo, , Russia
Kazan', , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Ufa, , Russia
Yaroslavl, , Russia
Yekaterinburg, , Russia
Cape Town, , South Africa
Cape Town, , South Africa
Durban, , South Africa
Buchun, , South Korea
Bundang City, , South Korea
Daegu, , South Korea
Goyang-si, , South Korea
Pusan, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Girona, , Spain
Madrid, , Spain
Valencia, , Spain
Valencia, , Spain
Changhua, , Taiwan
Kaohsiung City, , Taiwan
Taipei, , Taiwan
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Shhiye, Ankara, , Turkey (Türkiye)
Birmingham, , United Kingdom
Denbigh, , United Kingdom
Dundee, , United Kingdom
Glasgow, , United Kingdom
Manchester, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Weston-super-Mare, , United Kingdom
Wolverhampton, , United Kingdom
Countries
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References
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Van Cutsem E, Bang YJ, Feng-Yi F, Xu JM, Lee KW, Jiao SC, Chong JL, Lopez-Sanchez RI, Price T, Gladkov O, Stoss O, Hill J, Ng V, Lehle M, Thomas M, Kiermaier A, Ruschoff J. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer. 2015 Jul;18(3):476-84. doi: 10.1007/s10120-014-0402-y. Epub 2014 Jul 20.
Satoh T, Bang YJ, Gotovkin EA, Hamamoto Y, Kang YK, Moiseyenko VM, Ohtsu A, Van Cutsem E, Al-Sakaff N, Urspruch A, Hill J, Weber HA, Chung HC; ToGA Trial Investigators. Quality of life in the trastuzumab for gastric cancer trial. Oncologist. 2014 Jul;19(7):712-9. doi: 10.1634/theoncologist.2014-0058. Epub 2014 Jun 20.
Satoh T, Omuro Y, Sasaki Y, Hamamoto Y, Boku N, Tamura T, Ohtsu A. Pharmacokinetic analysis of capecitabine and cisplatin in combination with trastuzumab in Japanese patients with advanced HER2-positive gastric cancer. Cancer Chemother Pharmacol. 2012 Apr;69(4):949-55. doi: 10.1007/s00280-011-1783-9. Epub 2011 Nov 25.
Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
Other Identifiers
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BO18255
Identifier Type: -
Identifier Source: org_study_id
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