Trial information

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

Status: Recruiting

Protocol number: BO18255

Sponsor: Hoffmann-LaRoche Ltd/Inc/AG/Roche Global Development

Company division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of first-line Herceptin in combination with a fluoropyrimidine and cisplatin versus chemotherapy alone on progression-free survival in patients with HER2-positive advanced gastric cancer

Brief summary: This study will evaluate the efficacy, safety, pharmacokinetics and effect on quality of life of intravenous Herceptin in combination with 2 different regimens of 2 chemotherapy agents, compared with these chemotherapy regimens alone, in patients with HER2-positive advanced gastric cancer. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 584.

Study phase: III

Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study

Condition: Gastric Cancer

Intervention type: Drug

Intervention name: trastuzumab[Herceptin]

Primary outcome: 1. Efficacy: Overall survival

Key secondary outcomes: 1. Efficacy: Progression-free survival, overall response rate, clinical benefit rate, duration of response Safety: AEs, laboratory tests, vital signs, LVEF, creatinine clearance

Inclusion criteria:

• adult patients (>=18 years of age);
• inoperable locally advanced, recurrent, 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.

Gender: Males or Females

Age limits: Min: 18 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: September, 2005

Trial registration date: 08/31/2005

Date last updated: 10/15/2008

Link to trial result

This trial is being conducted at the following locations:

Australia

• Adelaide
• Brisbane
• Melbourne

Belgium

• Leuven

Brazil

• Barretos
• Rio De Janeiro
• Sao Paulo

China

• Beijing
• Guangzhou
• Jiangsu
• Nanjing
• Shanghai
• Suzhou
• Wuhan

Costa Rica

• San José

Denmark

• Herlev
• Odense

Finland

• Kangasala

France

• Brest
• Caen
• Colmar
• Lille
• Marseille
• Reims
• Rouen

Germany

• Heidelberg
• Mainz
• München
• Trier
• Witten

Guatemala

• Guatemala City

India

• Hyderabad
• Kochi
• Mumbai
• New Delhi

Italy

• Ancona
• Firenze
• Napoli
• Parma
• Roma
• Udine

Japan

• Aichi
• Chiba
• Ehime
• Fukuoka
• Hyogo
• Nagano
• Osaka
• Saitama
• Shizuoka
• Tochigi
• Tokyo
• Yamagata

Korea, Republic of

• Buchun
• Bundang City
• Daegu
• Kyunggi Do
• Pusan
• Seoul

Mexico

• Guadalajara
• Merida
• Mexico City
• Monterrey

Panama

• Panama City

Peru

• Callao
• Lima

Portugal

• Coimbra
• Guimaraes
• Lisboa
• Porto

Russian Federation

• Chelyabinsk
• Ivanovo
• Kazan
• Moscow
• Ryazan
• St Petersburg
• Ufa
• Yaroslavl

South Africa

• Cape Town
• Durban

Spain

• Barcelona
• Girona
• Madrid
• Valencia

Taiwan

• Changhua
• Taipei

Turkey

• Ankara
• Istanbul
• Izmir

United Kingdom

• Birmingham
• Bristol
• Denbigh
• Glasgow
• Manchester
• Wolverhampton