ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

This study has been completed.
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01041404
First received: December 29, 2009
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.


Condition Intervention Phase
Gastric Cancer
Drug: trastuzumab [Herceptin]
Drug: fluorouracil
Drug: cisplatin
Drug: capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival\n [ Time Frame: Through study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival, time to progression [ Time Frame: Tumor assessments: every 6 weeks ] [ Designated as safety issue: No ]
  • Overall response rate, clinical benefit rate, duration of response [ Time Frame: Tumor assessments: every 6 weeks ] [ Designated as safety issue: No ]
  • Safety: AEs, laboratory parameters, vital signs, LVEF, creatinine clearance [ Time Frame: AEs: throughout study, laboratory parameters, vital signs, creatinine clearance: 1x every cycle, LVEF: every 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 594
Study Start Date: September 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: trastuzumab [Herceptin]
loading dose 8 mg/kg, 6 mg/kg intravenous infusion every 3 weeks
Other Name: Herceptin
Drug: fluorouracil
800 mg/m2/day intravenous infusion every 3 weeks for 6 cycles
Drug: cisplatin
80 mg/m2 intravenous infusion every 3 weeks for 6 cycles
Drug: capecitabine
1000 mg/m2 po twice daily for 14 days every 3 weeks for 6 cycles
Other Name: Xeloda
Active Comparator: 2 Drug: fluorouracil
800 mg/m2/day intravenous infusion every 3 weeks for 6 cycles
Drug: cisplatin
80 mg/m2 intravenous infusion every 3 weeks for 6 cycles
Drug: capecitabine
1000 mg/m2 po twice daily for 14 days every 3 weeks for 6 cycles
Other Name: Xeloda

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients >=18 years of age
  • Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction
  • Adenocarcinoma
  • HER2-positive tumors

Exclusion Criteria:

  • Previous chemotherapy for advanced/metastatic disease
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041404

  Hide Study Locations
Locations
Australia
Adelaide, Australia, 5011
Kurralta Park, Australia, 5037
Melbourne, Australia, 3128
Milton, Australia, 4064
Perth, Australia, 6008
Sydney, Australia, 2217
Belgium
Leuven, Belgium, 3000
Brazil
Barretos, Brazil, 14784-400
Rio de Janeiro, Brazil, 20231-050
Sao Paulo, Brazil, 04023-900
Sao Paulo, Brazil, 05403-010
China
Beijing, China, 100021
Beijing, China, 100071
Beijing, China, 100853
Beijing, China, 100036
Guangdong, China, 510515
Guangzhou, China, 510060
Jiangsu, China, 210009
Nanjing, China, 210002
Shanghai, China, 200003
Shanghai, China, 200092
Shanghai, China, 200080
Shanghai, China, 200025
Shanghai, China, 200032
Shanghai, China, 200433
Suzhou, China, 215006
Wuhan, China, 430030
Costa Rica
San Jose, Costa Rica, 10103
San José, Costa Rica
Denmark
Herlev, Denmark, 2730
Odense, Denmark, 5000
Finland
Tampere, Finland, 33520
France
Brest, France, 29609
Caen, France, 14076
Colmar, France, 68024
Lille, France, 59020
Marseille, France, 13273
Reims, France, 51092
Rouen, France, 76031
Strasbourg, France, 67098
Germany
Heidelberg, Germany, 69120
Mainz, Germany, 55101
München, Germany, 81675
Trier, Germany, 54290
Witten, Germany, 58455
Guatemala
Guatemala City, Guatemala, 01015
India
Hyderabad, India, 500 033
Kochi, India, 682304
Mumbai, India, 400026
New Delhi, India, 110 029
Italy
Ancona, Italy, 60121
Firenze, Italy, 50139
Napoli, Italy, 80131
Parma, Italy, 43100
Roma, Italy, 00168
Udine, Italy, 33100
Japan
Aichi, Japan, 464-8681
Chiba, Japan, 277-8577
Ehime, Japan, 791-0280
Fukuoka, Japan, 812-8582
Hyogo, Japan, 650-0017
Nagano, Japan, 384-0392
Osaka, Japan, 589-8511
Osaka, Japan, 569-8686
Saitama, Japan, 362-0806
Saitama, Japan, 350-1298
Shizuoka, Japan, 411-8777
Tochigi, Japan, 320-0834
Tokyo, Japan, 135-8577
Tokyo, Japan, 113-8677
Tokyo, Japan, 135-8550
Yamagata, Japan, 990-8520
Korea, Republic of
Buchun, Korea, Republic of, 420-021
Bundang City, Korea, Republic of, 463-802
Daegu, Korea, Republic of, 702-210
Goyang-si, Korea, Republic of, 410-769
Pusan, Korea, Republic of, 602-715
Seoul, Korea, Republic of, 135-170
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 135-720
Seoul, Korea, Republic of
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 110-744
Mexico
Guadalajara, Mexico, 44280
Merida, Mexico, 97500
Mexico City, Mexico, 14000
Mexico City, Mexico, 06760
Monterrey, Mexico, 64020
Panama
Panama City, Panama
Peru
Callao, Peru
Lima, Peru, 18
Lima, Peru, 11
Portugal
Braga, Portugal, 4700
Coimbra, Portugal, 3000-075
Faro, Portugal, 8000
Guimaraes, Portugal, 4810-055
Lisboa, Portugal, 1649-035
Lisboa, Portugal, 1099-023
Porto, Portugal, 4200-072
Porto, Portugal, 4099-001
Porto, Portugal, 4200-319
Russian Federation
Chelyabinsk, Russian Federation, 454 087
Ekaterinburg, Russian Federation, 620905
Ivanovo, Russian Federation, 153040
Kazan, Russian Federation, 420029
Moscow, Russian Federation, 117837
Moscow, Russian Federation, 125284
Moscow, Russian Federation, 129128
Moscow, Russian Federation, 115478
Ryazan, Russian Federation, 390011
Samara, Russian Federation, 443031
St Petersburg, Russian Federation, 197022
St Petersburg, Russian Federation, 195067
St Petersburg, Russian Federation, 197758
UFA, Russian Federation, 450054
Yaroslavl, Russian Federation, 150054
South Africa
Cape Town, South Africa, 7506
Cape Town, South Africa, 1925
Durban, South Africa, 4091
Spain
Barcelona, Spain, 08036
Barcelona, Spain, 08041
Barcelona, Spain, 08907
Girona, Spain, 17007
Madrid, Spain, 28041
Valencia, Spain, 41014
Valencia, Spain, 46009
Taiwan
Changhua, Taiwan, 500
Kaohsiung, Taiwan, 807
Taipei, Taiwan, 00112
Turkey
Istanbul, Turkey
Istanbul, Turkey, 34300
Izmir, Turkey, 35100
Izmir, Turkey, 35340
Shhiye, Ankara, Turkey, 06100
United Kingdom
Birmingham, United Kingdom, B9 5SS
Denbigh, United Kingdom, LL18 5UJ
Dundee, United Kingdom, DD1 9SY
Glasgow, United Kingdom, G12 0YN
Manchester, United Kingdom, M2O 4BX
Weston Super Mare, United Kingdom, BS23 4TQ
Wirral, United Kingdom, CH63 4JY
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Chugai Pharmaceutical
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01041404     History of Changes
Other Study ID Numbers: BO18255
Study First Received: December 29, 2009
Last Updated: October 17, 2013
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Trastuzumab
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014