AzTrials
AzTrials

Neoplasms, Gastrointestinal TractPhase 3NCT00680901

LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib

A Phase 3 study testing Lapatinib, Capecitabine and Oxaliplatin in people with Neoplasms, Gastrointestinal Tract, run by Novartis Pharmaceuticals at 183 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplification of the ErbB2 (HER2) gene. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Gastrointestinal Tract
What is being tested?
Lapatinib, Capecitabine and Oxaliplatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
545 participants
Where
183 sitesin 23 countries
Study dates
4 Jun 2008to 3 Oct 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction.
  • Gastric cancer that is unresectable due to locally advanced (defined as stage IV: T4N1-3 or TanyN3), metastatic, or locally recurrent disease; Esophageal cancer that is unresectable due to locally advanced (T3N1 or T4Nany), metastatic or locally recurrent disease.
  • Measurable or non-measurable, but radiologically evaluable disease, according to RECIST.
  • HER2 amplification by FISH assessed by the local or designated central laboratory; Subjects with unknown HER2 status were not eligible.
  • Adequate organ function, as defined in the study protocol, assessed within 14 days prior randomization.
  • Cardiac ejection fraction within institutional range of normal as measured by echocardiogram (ECHO).
Show all 9Show fewer
  • Prior/Concurrent Therapy:
  • At least 3 weeks following major surgery, such as gastrectomy, and were recovered from any related toxicity More than 5 years since prior chemotherapy for malignancy other than GC. At least 4 weeks since prior radiotherapy
  • More than 5 years since prior biologic or hormonal therapy or immunotherapy for malignancy other than gastric carcinoma.

Who cannot join

  • Pregnant or lactating females at any time during the study.
  • Known history of active CNS disease.
  • Uncontrolled ascites.
  • Concurrent anti-cancer therapy (chemotherapy, radiation therapy other than for pain relief, immunotherapy, biologic therapy, hormonal therapy or surgery) while taking investigational treatment.
  • Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma.
  • Prior palliative chemotherapy for the treatment of gastric cancer.
Show all 11Show fewer
  • Prior treatment with oxaliplatin-based neoadjuvant or adjuvant chemotherapy completed <12 months.
  • Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease (such as Crohn's disease or ulcerative colitis).
  • Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
  • Uncontrolled infection.
  • History of other malignancy. However, subjects who were disease-free for 5 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, were eligible.

Trial locations and contacts

183 sites in 23 countries.

183 sites in 23 countries

Ukraine22 sites

  • Novartis Investigative Site

    Cherkasy, 18009

  • Novartis Investigative Site

    Chernivtsi, 58013

  • Novartis Investigative Site

    Dnipro, 49102

  • Novartis Investigative Site

    Dnipropetrovsk, 49100

  • Novartis Investigative Site

    Donetsk, 83092

  • Novartis Investigative Site

    Ivano-Frankivsk, 76018

  • Novartis Investigative Site

    Kharkiv, 61070

  • Novartis Investigative Site

    Kryvyi Rih, 50048

  • Novartis Investigative Site

    Kyiv, 03022

  • Novartis Investigative Site

    Kyiv, 03115

  • Novartis Investigative Site

    Kyiv, 04107

  • Novartis Investigative Site

    Lutsk, 43018

  • Novartis Investigative Site

    Lviv, 79031

  • Novartis Investigative Site

    Odesa, 65055

  • Novartis Investigative Site

    Plyuty, 08720

  • Novartis Investigative Site

    Simferopil, 95023

  • Novartis Investigative Site

    Simferopol, 95023

  • Novartis Investigative Site

    Sumy, 40005

  • Novartis Investigative Site

    Ternopil, 46023

  • Novartis Investigative Site

    Uzhhorod, 88000

  • Novartis Investigative Site

    Vinnitsia, 21029

  • Novartis Investigative Site

    Zaporizhzhya, 69040

Other trials in Ukraine

Italy19 sites

  • Novartis Investigative Site

    Bari, Apulia, 70124

  • Novartis Investigative Site

    Bergamo, Lombardy, 24128

  • Novartis Investigative Site

    Cesena, Emilia-Romagna, 47023

  • Novartis Investigative Site

    Florence, Tuscany, 50139

  • Novartis Investigative Site

    Genoa, Liguria, 16132

  • Novartis Investigative Site

    L’Aquila, Abruzzo, 67100

  • Novartis Investigative Site

    Meldola (FC), Emilia-Romagna, 47014

  • Novartis Investigative Site

    Modena, Emilia-Romagna, 41100

  • Novartis Investigative Site

    Parma, Emilia-Romagna, 43100

  • Novartis Investigative Site

    Pesasro, The Marches, 61122

  • Novartis Investigative Site

    Piacenza, Emilia-Romagna, 29100

  • Novartis Investigative Site

    Province of Macerata

  • Novartis Investigative Site

    Rimini, Emilia-Romagna, 47900

  • Novartis Investigative Site

    Rionero in Vulture (PZ), Basilicate, 85028

  • Novartis Investigative Site

    Rome, Lazio, 00152

  • Novartis Investigative Site

    Rome, Lazio, 00161

  • Novartis Investigative Site

    Rome, Lazio, 00168

  • Novartis Investigative Site

    Treviglio (BG), Lombardy, 24047

  • Novartis Investigative Site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

China15 sites

  • Novartis Investigative Site

    Beijing, 100021

  • Novartis Investigative Site

    Beijing, 100071

  • Novartis Investigative Site

    Beijing, 100853

  • Novartis Investigative Site

    Changchun, Jilin, 130012

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Fuzhou, 350025

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515

  • Novartis Investigative Site

    Hangzhou, 310016

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150040

  • Novartis Investigative Site

    Hefei, Anhui, 230022

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210002

  • Novartis Investigative Site

    Qingdao, 266061

  • Novartis Investigative Site

    Shanghai, 200032

  • Novartis Investigative Site

    Shanghai, 200080

  • Novartis Investigative Site

    Tianjin, 300060

Other trials in China

Brazil12 sites

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30110-090

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-281

  • Novartis Investigative Site

    Florianópolis, Santa Catarina, 88034-000

  • Novartis Investigative Site

    Jaú, São Paulo, 17210-120

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Novartis Investigative Site

    Rio de Janeiro, 20230-130

  • Novartis Investigative Site

    Santo André, São Paulo, 09060-650

  • Novartis Investigative Site

    São Paulo, São Paulo, 01221-020

  • Novartis Investigative Site

    São Paulo, São Paulo, 01246-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 01308-500

Other trials in Brazil

Poland12 sites

  • Novartis Investigative Site

    Gdansk, 80-219

  • Novartis Investigative Site

    Krakow, 31-501

  • Novartis Investigative Site

    Olsztyn, 10-226

  • Novartis Investigative Site

    Olsztyn, 10-513

  • Novartis Investigative Site

    Płock, 09-400

  • Novartis Investigative Site

    Poznan, 61-866

  • Novartis Investigative Site

    Rybnik, 44-200

  • Novartis Investigative Site

    Słupsk, 76-200

  • Novartis Investigative Site

    Szczecin, 70-111

  • Novartis Investigative Site

    Torun, 87-100

  • Novartis Investigative Site

    Warsaw, 02-507

  • Novartis Investigative Site

    Warsaw, 02-781

Other trials in Poland

Russia12 sites

  • Novartis Investigative Site

    Chelyabinsk, 454087

  • Novartis Investigative Site

    Kirov, 610021

  • Novartis Investigative Site

    Kursk, 305035

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Omsk, 644013

  • Novartis Investigative Site

    Ryazan, 390011

  • Novartis Investigative Site

    Saint Petersburg, 197758

  • Novartis Investigative Site

    Saint Petersburg, 198255

  • Novartis Investigative Site

    Saratov, 410004

  • Novartis Investigative Site

    Sochi, 354057

  • Novartis Investigative Site

    Stavropol, 355047

  • Novartis Investigative Site

    Ufa, 450054

Other trials in Russia

United States10 sites

  • Novartis Investigative Site

    Alhambra, California, 91801

  • Novartis Investigative Site

    Fullerton, California, 92835

  • Novartis Investigative Site

    Henderson, Nevada, 89052

  • Novartis Investigative Site

    La Verne, California, 91750

  • Novartis Investigative Site

    Northridge, California, 91328

  • Novartis Investigative Site

    Oxnard, California, 93030

  • Novartis Investigative Site

    Redondo Beach, California, 90277

  • Novartis Investigative Site

    Santa Maria, California, 93454

  • Novartis Investigative Site

    Santa Monica, California, 90404

  • Novartis Investigative Site

    Terre Haute, Indiana, 47802

Other trials in United States

India10 sites

  • Novartis Investigative Site

    Coimbatore, 641037

  • Novartis Investigative Site

    Kochi, 682041

  • Novartis Investigative Site

    Kochi

  • Novartis Investigative Site

    Kolkata, 700 053

  • Novartis Investigative Site

    Kolkata, 700026

  • Novartis Investigative Site

    Nagpur, 440010

  • Novartis Investigative Site

    New Delhi

  • Novartis Investigative Site

    Parel, 400012

  • Novartis Investigative Site

    Pune, 411001

  • Novartis Investigative Site

    Trivandrum, 695011

Other trials in India

South Korea10 sites

  • Novartis Investigative Site

    Busan, 602-030

  • Novartis Investigative Site

    Daegu, 700-712

  • Novartis Investigative Site

    Hwasun, 519-809

  • Novartis Investigative Site

    Seodaemun-gu, Seoul, 120-752

  • Novartis Investigative Site

    Seoul, 110-744

  • Novartis Investigative Site

    Seoul, 135-710

  • Novartis Investigative Site

    Seoul, 135-720

  • Novartis Investigative Site

    Seoul, 136-705

  • Novartis Investigative Site

    Suwon, 442-723

  • Novartis Investigative Site

    Suwon, Kyonggi-do, 443-721

Other trials in South Korea

Argentina9 sites

  • Novartis Investigative Site

    Buenos Aires, 1264

  • Novartis Investigative Site

    Cipolletti, Río Negro Province, R8324EMB

  • Novartis Investigative Site

    Ciudad Aut6noma de Buenos Aires, Buenos Aires, C1050AAK

  • Novartis Investigative Site

    La Rioja, F5300COE

  • Novartis Investigative Site

    Neuquén, Neuquén Province, Q8300HDH

  • Novartis Investigative Site

    Quilmes, Buenos Aires, 1878

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000KZE

  • Novartis Investigative Site

    San Miguel de Tucumán, 4000

  • Novartis Investigative Site

    Santa Fe, 3000

Other trials in Argentina

Canada9 sites

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2

  • Novartis Investigative Site

    London, Ontario, N6A 4L6

  • Novartis Investigative Site

    Montreal, Quebec, H2W 1S6

  • Novartis Investigative Site

    Montreal, Quebec, H3G 1A4

  • Novartis Investigative Site

    Saint John, New Brunswick, E2L 4L2

  • Novartis Investigative Site

    Toronto, Ontario, M4C 3E7

  • Novartis Investigative Site

    Toronto, Ontario, M5B 1W8

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Israel8 sites

  • Novartis Investigative Site

    Beersheba, 84101

  • Novartis Investigative Site

    Haifa, 31096

  • Novartis Investigative Site

    Jerusalem, 91031

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Rehovot, 76100

  • Novartis Investigative Site

    Tel Aviv, 64239

  • Novartis Investigative Site

    Zrifin, 70300

Other trials in Israel

Hungary7 sites

  • Novartis Investigative Site

    Győr, H-9024

  • Novartis Investigative Site

    Kaposvár, 7400

  • Novartis Investigative Site

    Kecskemét, 6000

  • Novartis Investigative Site

    Miskolc, 3526

  • Novartis Investigative Site

    Pécs, 7624

  • Novartis Investigative Site

    Szeged, 6720

  • Novartis Investigative Site

    Szolnok, 5004

Other trials in Hungary

Chile4 sites

  • Novartis Investigative Site

    Santiago, Región Metro de Santiago, 7500921

  • Novartis Investigative Site

    Santiago, 7510032

  • Novartis Investigative Site

    Temuco, Región de La Araucania, 481-0469

  • Novartis Investigative Site

    Viña del Mar, Valparaiso, 254-0364

Other trials in Chile

Taiwan4 sites

  • Novartis Investigative Site

    Tainan, 704

  • Novartis Investigative Site

    Taipei, 104

  • Novartis Investigative Site

    Taipei, 112

  • Novartis Investigative Site

    Taoyuan County, 333

Other trials in Taiwan

Mexico3 sites

  • Novartis Investigative Site

    Acapulco de Juárez, Guerrero, 39670

  • Novartis Investigative Site

    Mexico City, CP 14080

  • Novartis Investigative Site

    Oaxaca City, 68000

Other trials in Mexico

Netherlands3 sites

  • Novartis Investigative Site

    Amsterdam, 1105 AZ

  • Novartis Investigative Site

    Leeuwarden, 8934 AD

  • Novartis Investigative Site

    Nijmegen, 6525 GA

Other trials in Netherlands

Peru3 sites

  • Novartis Investigative Site

    Callao, Callao 2

  • Novartis Investigative Site

    Lima, Lima 11

  • Novartis Investigative Site

    Lima, Lima 34

Other trials in Peru

Thailand3 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Hatyai, Songkhla, 90110

Other trials in Thailand

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Ankara, 06500

  • Novartis Investigative Site

    Gaziantep, 27310

  • Novartis Investigative Site

    Trabzon, 61187

Other trials in Turkey (Türkiye)

Estonia2 sites

  • Novartis Investigative Site

    Tallinn, 13419

  • Novartis Investigative Site

    Tartu, 51014

Other trials in Estonia

Hong Kong2 sites

  • Novartis Investigative Site

    Pokfulam

  • Novartis Investigative Site

    Tuenmen

Other trials in Hong Kong

Puerto Rico1 site

  • Novartis Investigative Site

    San Juan, 00910

Other trials in Puerto Rico

About this study

Official title: A Phase III Study for ErbB2 Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma Treated With Capecitabine Plus Oxaliplatin With or Without Lapatinib

This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplification of the ErbB2 (HER2) gene. The trial investigated whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extended the time to progression and overall survival. Tumor ErbB2 (HER2) status had to be known before trial entry. CapeOx was administered to all patients, and patients were randomly assigned to receive either lapatinib or placebo.

Being tested
Lapatinib, Placebo, Capecitabine, Oxaliplatin
Keywords
unresectable, HER2, ErbB2, TYKERB, capecitabine, CapeOx, gastric/esophageal cancer, GE junction, metastatic, lapatinib, oxaliplatin
Medical subject headings
Neoplasms, Esophageal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LapatinibDrug

    Also called Tykerb

    5 pills at 250mg each once daily

  • PlaceboDrug

    5 pills once daily

  • CapecitabineDrug

    1700mg/m2/day in two daily doses

  • OxaliplatinDrug

    130mg/m2 on day 1

Study groups in NCT00680901
Study groupRoleWhat they receive
CapeOx plus LapatinibExperimentalCapeOx plus Lapatinib
Receives: Drug: Lapatinib; Drug: Capecitabine; Drug: Oxaliplatin
CapeOx plus PlaceboPlacebo comparatorCapeOx plus Placebo
Receives: Drug: Placebo; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival at the Time of Primary Analysis

    Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing.

    Measured: From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years)

  2. Overall Survival in All Randomized Participants at the Time of Primary Analysis

    Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing.

    Measured: From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years)

Secondary outcomes (15)

  1. Overall Survival at the Time of Final Analysis

    Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing.

    Measured: From date of randomization till death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  2. Progression Free Survival (PFS)

    Progression-Free Survival (PFS) was defined as the time from randomization to the earliest occurrence of disease progression or death from any cause. Per RECIST v1.0, progression was defined as at least a 20% increase in the sum of diameters of target lesions from the smallest recorded sum or the appearance of one or more new lesions. Participants with symptomatic progression, even without radiological confirmation, were also counted. Those who had neither progressed nor died were censored at their follow-up visit, either because follow-up had ended or was ongoing. Participants who received non-study anti-cancer therapies before progression were also censored.

    Measured: From date of randomization till the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  3. Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR)

    A participant was considered a responder if they had achieved either a complete response (CR), defined as the disappearance of all target and non-target lesions, or a partial response (PR), defined as at least a 30% reduction in the sum of the longest diameters of target lesions from baseline, as assessed by the investigator and confirmed by radiographic imaging within four weeks of the initial observation.

    Measured: From date of randomization till the date of the first documented response of CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  4. Percentage of Participants With Clinical Benefit (CB)

    Clinical Benefit (CB) was defined as evidence of a complete response (CR), partial response (PR), or stable disease (SD). CR referred to the disappearance of all target and non-target lesions, PR to at least a 30% reduction in the sum of the longest diameters of target lesions from baseline, and SD to neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression, based on the smallest sum of diameters recorded since treatment initiation. All assessments were made by the investigator.

    Measured: From date of randomization till date of disease progression (PD) or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  5. Time to Response (TTR)

    Time to Response (TTR) was defined as the duration from randomization to the first documented evidence of either a complete response (CR) (the disappearance of all target and non-target lesions) or a partial response (PR) (at least a 30% reduction in the sum of the longest diameters of target lesions from baseline) as assessed by the investigator.

    Measured: From date of randomization till the first documented evidence of confirmed CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  6. Duration of Response (DOR)

    Duration of Response (DOR) was defined as the time from the first documented evidence of a complete response (CR) or partial response (PR) until the first recorded sign of disease progression or death from any cause. According to RECIST, progression was defined as at least a 20% increase in the sum of diameters of target lesions from the smallest recorded sum or the appearance of one or more new lesions. Participants who had neither progressed nor died were censored at their follow-up visit, either because follow-up had ended or was ongoing. Those who received non-study anti-cancer therapies before progression were also censored.

    Measured: From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  7. Percentage of Participants With Any On-therapy Adverse Event (AE) and Serious Adverse Event (SAE)

    An Adverse Event (AE) was defined as any untoward medical occurrence in a participant that was temporally associated with the use of a medicinal product, regardless of its causal relationship. This included any unfavorable or unintended sign (such as abnormal lab findings), symptom, or disease, whether new or worsened. A Serious Adverse Event (SAE) was defined as any such occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or its prolongation, caused disability or incapacity, led to a congenital anomaly or birth defect, or was a potential case of drug-induced liver injury.

    Measured: From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  8. Percentage of Participants With On-therapy Adverse Event (AE) by Maximum Grade

    An Adverse Event (AE) was defined as any untoward medical occurrence in a participant that was temporally associated with the use of a medicinal product, regardless of its relationship to the product. This included any unfavorable or unintended sign (such as abnormal lab results), symptom, or disease, whether new or worsened. The severity of AEs was graded according to NCI CTCAE version 3.0: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to toxicity).

    Measured: From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  9. Percentage of Participants With On-therapy Serious Adverse Event (SAE) by Maximum Grade

    A Serious Adverse Event (SAE) was defined as any such occurrence that resulted in death, was life-threatening, required hospitalization or its prolongation, caused disability or incapacity, led to a congenital anomaly or birth defect, or was a potential case of drug-induced liver injury. The severity of SAEs was graded according to NCI CTCAE version 3.0: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to toxicity).

    Measured: From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  10. Mean Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) Domain Scores

    The EORTC QLQ-C30 is a comprehensive questionnaire developed for assessing the quality of life of cancer patients across different aspects including function scales namely physical, role, cognitive, emotional and social; symptom scales such as fatigue, pain, nausea and vomiting; and a global scale pronouncing overall health status. Its scoring method involves a 4-point Likert scale (ranging from 1 'Not at all' to 4 'Very Much'). Domain scores are calculated by averaging the items within the respective domain and then linearly transforming the score to fit within a 0-100 scale to finalize the scores. In terms of interpretation, a high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  11. Mean Change From Baseline in the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) Scales/Items Score Scale

    The QLQ-STO22 consists of 22 items divided into five subscales: dysphagia, pain, reflux, eating restrictions and anxiety, as well as single items addressing dry mouth, body image, taste, and hair loss. Each item is answered on a 4-point scale, ranging from 1 (not at all) to 4 (very much). Raw scores for each subscale or single item are calculated by averaging the scores of the individual items that make up the scale. These scores are then linearly transformed to range from 0 to 100. In terms of interpretation, a higher score indicates a worse quality of life concerning the specific symptoms assessed.

    Measured: From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  12. Mean Change From Baseline in Utility Score (Health Utility Index) in the EuroQoL-5 Dimensions (EQ-5D) Questionnaire

    The EQ-5D is a standardized instrument developed by the EuroQoL Group to measure health-related quality of life. It includes a descriptive system covering five dimensions and a Visual Analogue Scale (VAS), often referred to as the Thermometer Score.

    The Utility Score (Health Utility Index) is derived from the five dimensions of the EQ-5D descriptive system (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has levels indicating severity (e.g., 1 = no problems, 2 = some problems, 3 = extreme problems). These combinations form a health state, which is then converted into a single index value using a country-specific value set. In the UK-based value set, the possible EQ-5D index utility values range from -0.594 to 1.0, where: 1.0 = perfect health, 0 = death and < 0 = health states considered worse than death.

    Measured: From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  13. Mean Change From Baseline in Thermometer Score (EQ VAS) in the EuroQoL-5 Dimensions (EQ-5D) Questionnaire

    The EQ-5D is a standardized instrument developed by the EuroQol Group to measure health-related quality of life. It includes a descriptive system covering five dimensions and a Visual Analogue Scale (VAS), often referred to as the Thermometer Score.

    The Thermometer Score is a self-rated health score using a vertical visual analogue scale , where respondents rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).

    Measured: From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  14. Percentage of Participants With Worst-case On-therapy Chemistry Toxicities

    The severity of chemistry parameters was graded according to NCI CTCAE version 3.0: Grade 0 (No adverse event or within normal limits), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life-threatening).

    Chemistry data included: Alanine aminotransferase (ALT), Albumin, Alkaline phosphatases (ALP), Aspartate aminotransferase (AST), Calcium (hypercalcemia), Calcium (hypocalcemia), Creatine Kinase (CK), Creatine, Glucose (hyperglycemia), Glucose (hypoglycemia), Magnesium (hypermagnesemia), Magnesium (hypomagnesemia), Potassium (hyperkalemia), Potassium (hypokalemia), Sodium (hypernatremia), Sodium (hyponatremia) and Total Bilirubin.

    Measured: From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

  15. Percentage of Participants With Worst-case On-therapy Hematologic Toxicities

    The severity of hematologic parameters was graded according to NCI CTCAE version 3.0: Grade 0 (No adverse event or within normal limits), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life-threatening).

    Hematology data included: Hemoglobin, Platelet count, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count) and White Blood Cell count.

    Measured: From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2008 (estimated)
  2. Study start4 Jun 2008
  3. Primary completion24 Sep 2012
  4. Study completion3 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
545 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00680901
Sponsor's protocol ID
EGF110656
Other IDs
2007-005725-29, CLAP016C2301
Status last verified
Jul 2025
First submitted
15 May 2008
Last updated
7 Aug 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Chu MP, Hecht JR, Slamon D, Wainberg ZA, Bang YJ, Hoff PM, Sobrero A, Qin S, Afenjar K, Houe V, King K, Koski S, Mulder K, Hiller JP, Scarfe A, Spratlin J, Huang YJ, Khan-Wasti S, Chua N, Sawyer MB. Association of Proton Pump Inhibitors and Capecitabine Efficacy in Advanced Gastroesophageal Cancer: Secondary Analysis of the TRIO-013/LOGiC Randomized Clinical Trial. JAMA Oncol. 2017 Jun 1;3(6):767-773. doi: 10.1001/jamaoncol.2016.3358.

    PubMed 27737436

  • Hecht JR, Bang YJ, Qin SK, Chung HC, Xu JM, Park JO, Jeziorski K, Shparyk Y, Hoff PM, Sobrero A, Salman P, Li J, Protsenko SA, Wainberg ZA, Buyse M, Afenjar K, Houe V, Garcia A, Kaneko T, Huang Y, Khan-Wasti S, Santillana S, Press MF, Slamon D. Lapatinib in Combination With Capecitabine Plus Oxaliplatin in Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma: TRIO-013/LOGiC--A Randomized Phase III Trial. J Clin Oncol. 2016 Feb 10;34(5):443-51. doi: 10.1200/JCO.2015.62.6598. Epub 2015 Nov 30.

    PubMed 26628478

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lapatinib, Capecitabine and Oxaliplatin in people with Neoplasms, Gastrointestinal Tract, run by Novartis Pharmaceuticals at 183 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in Ukraine, Italy, China, Brazil, Poland and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival at the Time of Primary Analysis (time frame: From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00680901, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in