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CarcinomaPhase 3MISSIONNCT00863746

A 3rd/4th Line Placebo-controlled Trial of Sorafenib in Patients With Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC).

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma and Non-Small-Cell Lung, run by Bayer at 182 sites in 34 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

The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Sorafenib (Nexavar, BAY43-9006)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
703 participants
Where
182 sitesin 34 countries
Study dates
Apr 2009to Apr 2013
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

  • Ability to understand and willingness to sign a written Informed Consent
  • Advanced relapsed or refractory predominantly non squamous NSCLC. The diagnosis must have been confirmed cyto-/ histologically
  • Patients must have measurable or non-measurable disease
  • At least two but not more than three prior standard treatment regimens for NSCLC
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Male or female subjects >/= 18 years of age (>/=20 for Japan) at the time of Informed Consent
Show all 19Show fewer
  • Life expectancy of at least 12 weeks
  • Ability to swallow oral medication
  • Both men and women using adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of the study drug:
  • Haemoglobin > 9.0 g/dl
  • Absolute neutrophil count (ANC) >1,500/mm3
  • Platelet count >/= 100,000/µl
  • Total bilirubin </=1.5 x the upper limit of normal
  • Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases) Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases)
  • Alkaline phosphatase < 4 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases)
  • Prothrombin Time (PT)-International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal
  • Serum creatinine < 1.5 x upper limit of normal
  • Calculated creatinine clearance of >/= 50 mL/min

Who cannot join

  • NSCLC patients with predominantly squamous cell carcinoma histology
  • Excluded medical conditions:
  • History of cardiac disease: Congestive heart failure, Active coronary artery disease (CAD), Cardiac arrhythmias (>Grade 2 NCI-CTCAE [National Cancer Institute-Common Terminology Criteria for Adverse Events] vers. 3.0)
  • Uncontrolled hypertension despite two anti-hypertensive medications
  • History of Human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • History of organ allograft
Show all 16Show fewer
  • Active clinically serious infections (> grade 2 NCI-CTCAE vers. 3.0)
  • Patients with seizure disorder requiring medication
  • Patients with evidence or history of bleeding diathesis or coagulopathy
  • Patients undergoing renal dialysis
  • Pulmonary hemorrhage/ bleeding event >/= CTCAE grade 2 within four weeks prior to the first dose of the study drug
  • Any other hemorrhage/ bleeding event >/= CTCAE grade 3 within four weeks prior to the first dose of the study drug
  • Thrombotic or embolic venous or arterial events such as cerebrovascular accident
  • Pregnant or breast-feeding women.
  • Any condition which could affect the absorption or pharmacokinetics of the study drug
  • Prior treatment with other Vascular Endothelial Growth Factor (VEGF) (R) inhibitors, including compounds that impact vascularity (i.e. sunitinib, thalidomide, vandetanib, vascular disrupting agents [VDA], VEGF-trap and other experimental agents of this class). Only bevacizumab (Avastin) is permitted.

Trial locations and contacts

182 sites in 34 countries.

182 sites in 34 countries

China12 sites

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100071

  • Study site

    Beijing, 100142

  • Study site

    Beijing, 100853

  • Study site

    Chengdu, Sichuan, 610041

  • Study site

    Guangzhou, Guangdong, 510060

  • Study site

    Guangzhou, 510080

  • Study site

    Hangzhou, Zhejiang, 310016

  • Study site

    Hangzhou, Zhejiang, 310022

  • Study site

    Nanjing, Jiangsu, 210002

  • Study site

    Shanghai, 200030

  • Study site

    Shanghai, 200433

Other trials in China

Germany11 sites

  • Study site

    Bad Berka, Thuringia, 99437

  • Study site

    Cologne, North Rhine-Westphalia, 51109

  • Study site

    Gauting, Bavaria, 82131

  • Study site

    Großhansdorf, Schleswig-Holstein, 22927

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 21075

  • Study site

    Heidelberg, Baden-Wurttemberg, 69126

  • Study site

    Karlsruhe, Baden-Wurttemberg, 76137

  • Study site

    Kassel, Hesse, 34125

  • Study site

    Mannheim, Baden-Wurttemberg, 68167

  • Study site

    München, Bavaria, 80336

  • Study site

    Ulm, Baden-Wurttemberg, 89091

Other trials in Germany

Spain10 sites

  • Study site

    Barcelona, Barcelona, 08025

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Cruces/Barakaldo, Bilbao, 48903

  • Study site

    Lleida, Lleida, 25198

  • Study site

    Lugo, Lugo, 27003

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Málaga, Málaga, 29010

  • Study site

    Ourense, Ourense, 32005

  • Study site

    Seville, Sevilla, 41013

  • Study site

    Zamora, Zamora, 49021

Other trials in Spain

Italy9 sites

  • Study site

    Avellino, 83100

  • Study site

    Genova, 16132

  • Study site

    Livorno, 57124

  • Study site

    Monza, Monza-Brianza, 20052

  • Study site

    Orbassano, Torino, 10043

  • Study site

    Parma, 43100

  • Study site

    Perugia, 06156

  • Study site

    Roma, 00151

  • Study site

    Rozzano, Milano, 20089

Other trials in Italy

Brazil8 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30150-281

  • Study site

    Brasília, Federal District, 70680-650

  • Study site

    Porto Alegre, Rio Grande do Sul, 90050 170

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    Santo André, São Paulo, 09020 110

  • Study site

    São José dos Campos, São Paulo, 12245750

  • Study site

    São Paulo, São Paulo, 01224-010

  • Study site

    São Paulo, São Paulo, 05651-900

Other trials in Brazil

France8 sites

  • Study site

    Caen, 14073

  • Study site

    Dijon, 21000

  • Study site

    La Roche-sur-Yon, 85025

  • Study site

    La Tronche, 38700

  • Study site

    Lille, 59020

  • Study site

    Lyon, 69317

  • Study site

    Saint-Herblain, 44805

  • Study site

    Tours, 37044

Other trials in France

Japan8 sites

  • Study site

    Akashi, Hyōgo, 673-8558

  • Study site

    Fukuoka, Fukuoka, 811-1395

  • Study site

    Kashiwa, Chiba, 277-8577

  • Study site

    Koto-ku, Tokyo, 135-8550

  • Study site

    Nagoya, Aichi-ken, 464-8681

  • Study site

    Sakai, Osaka, 591-8555

  • Study site

    Sayama, Osaka, 589-8511

  • Study site

    tabashi City, Tokyo, 173-8606

Other trials in Japan

United Kingdom8 sites

  • Study site

    Aberdeen, AB25 2ZN

  • Study site

    Bristol, Avon, BS10 5NB

  • Study site

    Cambridge, Cambridgeshire, CB2 0QQ

  • Study site

    Greater Manchester, Manchester, M20 4BX

  • Study site

    Leeds, West Yorkshire, LS9 7TF

  • Study site

    London, London, NW3 2QG

  • Study site

    London, London, SW3 6JJ

  • Study site

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Argentina7 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1430ERF

  • Study site

    Córdoba, Córdoba Province, 5000

  • Study site

    Córdoba, Córdoba Province, X5016KEH

  • Study site

    Ramos Mejía, Buenos Aires, B1704ESN

  • Study site

    Rosario, Santa Fe Province, 2000

  • Study site

    Rosario, Santa Fe Province, S2000DSK

  • Study site

    Santa Fe, S3000FFV

Other trials in Argentina

Hungary6 sites

  • Study site

    Budapest, 1125

  • Study site

    Budapest, 1529

  • Study site

    Edelény, 3780

  • Study site

    Farkasgyepű, 8582

  • Study site

    Törökbálint, 2045

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

Israel6 sites

  • Study site

    Holon

  • Study site

    Jerusalem, 9112001

  • Study site

    Jerusalem, 9372212

  • Study site

    Kfar Saba, 4428164

  • Study site

    Petah Tikva, 4941492

  • Study site

    Zrifin, Israel, 6093000

Other trials in Israel

Netherlands6 sites

  • Study site

    Amsterdam, 1081HV

  • Study site

    Harderwijk, 3844 DG

  • Study site

    Heerlen, 6419 PC

  • Study site

    Helmond, 5707 HA

  • Study site

    Nieuwegein, 3435 CM

  • Study site

    Zwolle, 8025 AB

Other trials in Netherlands

Peru6 sites

  • Study site

    Callao, CALLAO 2

  • Study site

    Lima, LIMA 11

  • Study site

    Lima, LIMA 1

  • Study site

    Lima, LIMA 27

  • Study site

    Lima, LIMA 34

  • Study site

    San Borja

Other trials in Peru

Poland6 sites

  • Study site

    Kielce, 25-316

  • Study site

    Krakow, 31-115

  • Study site

    Olsztyn, 10-357

  • Study site

    Rzeszów, 35-021

  • Study site

    Szczecin, 70-891

  • Study site

    Warsaw, 01-138

Other trials in Poland

Russia6 sites

  • Study site

    Kazan', 420029

  • Study site

    Moscow, 105 005

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 129128

  • Study site

    Saint Petersburg, 198255

  • Study site

    Yaroslavl, 150054

Other trials in Russia

Bulgaria5 sites

  • Study site

    Plovdiv

  • Study site

    Sofia, 1784

  • Study site

    Sofia

  • Study site

    Varna, 9002

  • Study site

    Varna, 9010

Other trials in Bulgaria

South Africa5 sites

  • Study site

    Cape Town, Western Cape, 7500

  • Study site

    Durban, KwaZulu-Natal, 4126

  • Study site

    Johannesburg, Gauteng, 2196

  • Study site

    Port Elizabeth, Eastern Cape, 6045

  • Study site

    Prietoria, Gauteng, 0084

Other trials in South Africa

South Korea5 sites

  • Study site

    Seoul, Seoul Teugbyeolsi, 110-744

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 136-705

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 138-736

Other trials in South Korea

Sweden5 sites

  • Study site

    Falun, 791 82

  • Study site

    Gothenburg, 413 45

  • Study site

    Linköping, 581 85

  • Study site

    Lund, 221 85

  • Study site

    Stockholm, 171 76

Other trials in Sweden

Taiwan5 sites

  • Study site

    Kaohsiung City, 80756

  • Study site

    Taichung, 404

  • Study site

    Taichung, 40705

  • Study site

    Taipei, 10016

  • Study site

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Study site

    Ankara

  • Study site

    Instanbul, 34662

  • Study site

    Istanbul

  • Study site

    Izmir

  • Study site

    Kocaeli, 41400

Other trials in Turkey (Türkiye)

Belgium4 sites

  • Study site

    Antwerp, 2020

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Charleroi, 6000

  • Study site

    Genk, 3600

Other trials in Belgium

Philippines4 sites

  • Study site

    Cebu City, 6000

  • Study site

    Manila, 1000

  • Study site

    Metro Manila, 1000

  • Study site

    Quezon City, 1104

Other trials in Philippines

United States3 sites

  • Study site

    Fayetteville, Arkansas, 72703

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Stanford, California, 94305

Other trials in United States

Austria3 sites

  • Study site

    Graz, 8036

  • Study site

    Linz, 4010

  • Study site

    Vienna, State of Vienna, 1090

Other trials in Austria

Greece3 sites

  • Study site

    Athens, 11527

  • Study site

    Heraklion, 711 10

  • Study site

    Thessaloniki, 570 10

Other trials in Greece

Hong Kong3 sites

  • Study site

    Hong Kong

  • Study site

    Kowloon

  • Study site

    Shatin, N.T

Other trials in Hong Kong

India3 sites

  • Study site

    Kerala, 682304

  • Study site

    Mumbai, Maharashtra, 422004

  • Study site

    Pune, Maharashtra, 411001

Other trials in India

Thailand3 sites

  • Study site

    Bangkok, 10700

  • Study site

    Chiang Mai, 50200

  • Study site

    Songkhla, 90110

Other trials in Thailand

Chile2 sites

  • Study site

    Santiago, Santiago Metropolitan, 838-0455

  • Study site

    Santiago, 838-0456

Other trials in Chile

Indonesia2 sites

  • Study site

    Bandung, 40161

  • Study site

    Jakarta, 11420

Other trials in Indonesia

Pakistan2 sites

  • Study site

    Karachi, Sindh, 74700

  • Study site

    Lahore, Punjab Province, 54000

Other trials in Pakistan

Singapore2 sites

  • Study site

    Singapore, 119228

  • Study site

    Singapore, 308433

Other trials in Singapore

Canada1 site

  • Study site

    Montreal, Quebec, H2W 1S6

Other trials in Canada

About this study

Official title: A Phase III, Multi-center, Placebo-Controlled Trial of Sorafenib (BAY43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens for Advanced Disease

The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.

Read the detailed description

Acronyms used in Adverse Events section: Disseminated intravascular coagulation (DIC), International normalized ratio (INR), Atrioventricular (AV), Gastrointestinal (GI), Not otherwise specified (NOS), Common Terminology Criteria for Adverse Events (CTCAE), Absolute neutrophil count (ANC), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST).

Being tested
Sorafenib (Nexavar, BAY43-9006), Placebo
Keywords
Non-Small Cell Lung Cancer (NSCLC), Sorafenib
Medical subject headings
Carcinoma, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Sorafenib (Nexavar, BAY43-9006)Drug

    Sorafenib 400 mg twice daily (BID)

  • PlaceboDrug

    Placebo - 2 tablets twice daily (BID)

Study groups in NCT00863746
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006)ExperimentalParticipants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)
PlaceboPlacebo comparatorParticipants received 2 tablets of placebo orally twice daily (BID)
Receives: Drug: Placebo

What is being measured

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

  1. Overall Survival

    Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first.

    Measured: From randomization of the first subject until 36 months later

Secondary outcomes (9)

  1. Progression-free Survival

    Progression-free survival (PFS) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute progressive disease. In exceptional circumstances unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.

    Measured: From randomization of the first subject until 36 months later assessed every 6 weeks

  2. Disease Control

    Disease control (DC) was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] or Stable Disease [SD: steady state of disease which was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD)].

    Measured: From randomization of the first subject until 36 months later assessed every 6 weeks

  3. Objective Tumor Response

    Objective tumor response was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] over the whole duration of study.

    Measured: From randomization of the first subject until 36 months later assessed every 6 weeks

  4. Time to Progression

    Time to progression (TTP) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier).

    Measured: From randomization of the first subject until 36 months later assessed every 6 weeks

  5. Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status

    The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The 'Global Health status' subscale consists of question 15 of the questionnaire. The score of 'Global Health status' ranges from 0 (very poor) to 100 (excellent). The change of score ranges from -100 (maximum degree of worsening) to 100 (maximum degree of improvement).

    Measured: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)

  6. Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale

    A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The coughing subscale uses question 1 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).

    Measured: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)

  7. Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea

    A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The dyspnea subscale uses questions 3, 4 and 5 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).

    Measured: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)

  8. Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score

    The Euro-Qol 5D (EQ-5D) is a validated assessment tool of Health Related Quality of Life (HRQOL) and utilities consisting of 15 statements. Patients select those statements that best describe their current health state regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression which is converted into a utility value. Range of scale is from -0.594 (worst possible health state) to 1 (perfect health) based on UK weights. The change of score ranges from -1.594 (high degree of worsening) to 1.594 (high degree of improvement).

    Measured: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)

  9. Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score

    A visual analogue scale (EQ VAS) used by patients to rate their current health state from 100 (best imaginable health state) to 0 (worst imaginable health state). The change of score ranges from -100 (high degree of worsening) to 100 (high degree of improvement)

    Measured: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)

Timeline

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

  1. First posted18 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionMar 2012
  4. Study completionApr 2013

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
703 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00863746
Sponsor's protocol ID
13266
Other IDs
2008-006914-62, 2008
Acronym
MISSION
Status last verified
Jan 2015
First submitted
17 Mar 2009
Last updated
19 Jan 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma and Non-Small-Cell Lung, run by Bayer at 182 sites in 34 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 19 inclusion and 16 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 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in China, Germany, Spain, Italy, Brazil and 29 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 30 Jul 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 (time frame: From randomization of the first subject until 36 months later). 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 NCT00863746.

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 19 Jan 2015.

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