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

Sponsor:	Hoffmann-La Roche
Collaborator:	Chugai Pharmaceutical
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01041404

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 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:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Fluorouracil Cisplatin Capecitabine Trastuzumab

U.S. FDA Resources

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

Arms	Assigned Interventions
Experimental: 1	Drug: trastuzumab 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

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

Show 141 Study Locations

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):

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, Rüschoff 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. Epub 2010 Aug 19.

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01041404 History of Changes
Other Study ID Numbers:	BO18255
Study First Received:	December 29, 2009
Last Updated:	September 23, 2010
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
Trastuzumab
Capecitabine
Cisplatin

Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2012