Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC
NCT ID: NCT00806819
Last Updated: 2017-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
718 participants
INTERVENTIONAL
2008-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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nintedanib (BIBF1120) plus pemetrexed
nintedanib (BIBF1120) along with standard therapy of pemetrexed
Nintedanib (BIBF1120)
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
Folic Acid
400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.
Pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
Placebo plus pemetrexed
Pemetrexed standard therapy
pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
placebo
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
Folic Acid
400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.
nintedanib (BIBF1120) monotherapy
nintedanib (BIBF1120) monotherapy only for patients who discontinue pemetrexed
Nintedanib (BIBF1120)
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
pemetrexed monotherapy
pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo
Pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
Folic Acid
400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.
placebo monotherapy
placebo monotherapy only for patients who discontinue pemetrexed
placebo
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
Interventions
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Nintedanib (BIBF1120)
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
Pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
placebo
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
Folic Acid
400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.
B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
Folic Acid
400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.
placebo
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
Folic Acid
400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.
Nintedanib (BIBF1120)
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.
Pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed Stage IIIB, IV (according to AJCC) or recurrent non small cell lung cancer (NSCLC) (non squamous histologies)
3. Relapse or failure of one first line chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy).
4. At least one target tumor lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT.
5. Life expectancy of at least three months.
6. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
7. Patient has given written informed consent which must be consistent with the International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local legislation.
Exclusion Criteria
2. Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
3. Chemotherapy, hormone therapy, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for treatment of extremities) within the past four weeks prior to treatment with the trial drug, i.e., the minimum time elapsed since the last anticancer therapy and the first administration of BIBF 1120 must be four weeks
4. Inability to stop intake of NSAIDS (non steroidal anti inflammatory drugs) for several days
5. Active brain metastases (e.g. stable for \<4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants). Dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation)
6. Radiographic evidence of cavitary or necrotic tumors
7. Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
8. History of clinically significant haemoptysis within the past 3 months
9. Therapeutic anticoagulation
10. History of major thrombotic or clinically relevant major bleeding event in the past 6 months
11. Significant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months,
12. Inadequate kidney, liver, blood clotting function
13. Inadequate blood count
14. Significant weight loss (\> 10 %) within the past 6 weeks prior to treatment in the present trial
15. Current peripheral neuropathy greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except due to trauma
16. Pre-existing ascites (abdominal fluid collection) and/or clinically significant pleural effusion ( fluid collection between the lung and chest wall)
17. Major injuries and/or surgery within the past ten days prior to start of study drug
18. Incomplete wound healing
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Boehringer Ingelheim Investigational Site
Downy, California, United States
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Fountain Valley, California, United States
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Fullerton, California, United States
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Long Beach, California, United States
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Meriden, Connecticut, United States
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Aventura, Florida, United States
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Boynton Beach, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Port Saint Lucie, Florida, United States
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Stuart, Florida, United States
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Galesburg, Illinois, United States
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Skokie, Illinois, United States
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Indianapolis, Indiana, United States
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New Albany, Indiana, United States
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Witchita, Kansas, United States
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Ashland, Kentucky, United States
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Louisville, Kentucky, United States
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Burlington, Massachusetts, United States
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Springfield, Massachusetts, United States
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Saint Louis Park, Minnesota, United States
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Grand Island, Nebraska, United States
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Farmington, New Mexico, United States
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Dunkirk, New York, United States
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Goshen, New York, United States
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Lake Success, New York, United States
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Nyack, New York, United States
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Asheville, North Carolina, United States
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Canton, Ohio, United States
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Sandusky, Ohio, United States
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Ephrata, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Germantown, Tennessee, United States
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Amarillo, Texas, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Bs. As. Codigo Buenos Aires, , Argentina
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Córdoba, , Argentina
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Pergamino, , Argentina
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Quilmes Buenos Aires, , Argentina
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Rosario, Santa Fe, , Argentina
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San Miguel de Tucumán, , Argentina
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Sydney, New South Wales, Australia
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Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Toorak Gardens, South Australia, Australia
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Melbourne, Victoria, Australia
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Perth, Western Australia, Australia
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Sydney, , Australia
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Banja Luka, , Bosnia and Herzegovina
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Sarajevo, , Bosnia and Herzegovina
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Belo Horizonte, , Brazil
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Belo Horizonte,Minas Gerais, , Brazil
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Cachoeira Do Itapemirim-ES, , Brazil
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Campinas SP, , Brazil
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Caxias do Sul, , Brazil
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Curitiba, , Brazil
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Florianópolis, , Brazil
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Goiania Goias, , Brazil
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Ijuí, , Brazil
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Itajaí, , Brazil
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Jau/SP, , Brazil
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Londrina, Parana, , Brazil
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Pelotas Rio Grande Do Sul, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Salvador Bahia, , Brazil
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Santo André, , Brazil
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Sao Paulo - SP, , Brazil
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São Paulo, , Brazil
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Sorocaba Sao Paulo, , Brazil
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Jardin Del Mar, Renaca, , Chile
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Las Condes, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Monteria, Cordoba, , Colombia
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Cuenca, , Ecuador
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Quito, , Ecuador
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Augsburg, , Germany
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Berlin, , Germany
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Gauting, , Germany
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Halle, , Germany
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Hemer, , Germany
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München, , Germany
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Hong Kong, , Hong Kong
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Deszk, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Dublin, , Ireland
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Daugavpils, , Latvia
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Liepāja, , Latvia
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Riga, , Latvia
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George Town, , Malaysia
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Kota Kinabalu, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuching, , Malaysia
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Chihuahua City, , Mexico
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Morelia, , Mexico
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Chisinau, , Moldova
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's-Hertogenbosch, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Palmerston North, , New Zealand
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Wellington, , New Zealand
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Bitola, , North Macedonia
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Skopje, , North Macedonia
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Carrasquilla Panama, , Panama
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Panama City, , Panama
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Arequipa, , Peru
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Cercado Arequipa, , Peru
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Lima, , Peru
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Cebu, , Philippines
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Davao City, , Philippines
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Makati, , Philippines
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Quezon, , Philippines
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Olsztyn, , Poland
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Baia Mare, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Onești, , Romania
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Timișoara, , Romania
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Niš, , Serbia
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Daegu, , South Korea
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Daejoen, , South Korea
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Gangdong-gu, Seoul, , South Korea
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Gyeonggi-do, , South Korea
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Jeonbuk, , South Korea
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Seochogu, Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Gävle, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Uppsala, , Sweden
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Aydin, , Turkey (Türkiye)
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Balcali-Adana, , Turkey (Türkiye)
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Diyarbakır, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Chernihiv, , Ukraine
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Dnipropetrovks, , Ukraine
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Kharkiv, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
Countries
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References
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Lesaffre E, Edelman MJ, Hanna NH, Park K, Thatcher N, Willemsen S, Gaschler-Markefski B, Kaiser R, Manegold C. Statistical controversies in clinical research: futility analyses in oncology-lessons on potential pitfalls from a randomized controlled trial. Ann Oncol. 2017 Jul 1;28(7):1419-1426. doi: 10.1093/annonc/mdx042.
Other Identifiers
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2008-002072-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1199.14
Identifier Type: -
Identifier Source: org_study_id
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