Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients
NCT ID: NCT04737187
Last Updated: 2024-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
492 participants
INTERVENTIONAL
2020-11-25
2023-09-12
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
NONE
Study Groups
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Trifluridine/Tipiracil + Bevacizumab
Participants were administered 35 milligrams per square meter per dose (mg/m²/dose) trifluridine/tipiracil (FTD/TPI) orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 an Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab (5 milligrams per kilogram \[mg/kg\], intravenous \[IV\] infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.
Trifluridine/Tipiracil
Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest
Bevacizumab
administered every 2 weeks (Day 1 and Day 15)
Trifluridine/Tipiracil
Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.
Trifluridine/Tipiracil
Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest
Interventions
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Trifluridine/Tipiracil
Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest
Bevacizumab
administered every 2 weeks (Day 1 and Day 15)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy.
3. Has received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.
4. Has measurable or non-measurable disease as defined by RECIST version 1.1
5. Is able to swallow oral tablets.
6. Estimated life expectancy ≥12 weeks.
7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
Exclusion Criteria
2. Pregnancy, lactating female or possibility of becoming pregnant during the study.
3. Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization.
4. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation).
5. Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
6. Has severe or uncontrolled active acute or chronic infection.
7. Has active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
8. Known Hepatitis B or Hepatitis C Virus infection.
9. Known carriers of HIV antibodies.
10. Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia.
11. Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization.
12. Treatment with any of the following within the specified time frame prior to randomization:
* major surgery within 4 weeks prior to randomisation (the surgical incision should be fully healed prior to study drug administration), or has not recovered from side effects of previous surgery, or patient that may require major surgery during the study
* Prior radiotherapy if completed less than 4 weeks before randomisation, except if provided as a short course for symptoms palliation only.
* Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks prior to randomization
13. Other clinically significant medical conditions.
14. Other malignancies.
18 Years
ALL
No
Sponsors
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Institut de Recherches Internationales Servier
OTHER
Taiho Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Josep Tabernero, Prof
Role: PRINCIPAL_INVESTIGATOR
Vall d'Hebron Institute of Oncology
Locations
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Mayo Clinic Hospital
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
City of Hope - South Pasedena
South Pasadena, California, United States
City of Hope - Upland
Upland, California, United States
Mayo Clinic - FL
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States
DuPage Medical Group - Joliet Oncology-Hematology Associates
Joliet, Illinois, United States
Investigative Clinical Research of Indiana LLC
Noblesville, Indiana, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Mayo Clinic - Rochester
Rochester, New York, United States
Renovatio Clinical - El Paso
El Paso, Texas, United States
"Medizinische Universität Graz "
Graz, , Austria
"Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V"
Innsbruck, , Austria
"Ordensklinikum Linz Barmherzige Schwestern Interne I"
Linz, , Austria
"Landeskrankenhaus Feldkirch Interne E"
Rankweil, , Austria
"Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)"
Salzburg, , Austria
"Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie"
Vienna, , Austria
"Landesklinikum Wiener Neustadt "
Wiener Neustadt, , Austria
"OLV Ziekenhuis Oncology"
Aalst, , Belgium
"Universitair Ziekenhuis Antwerpen Oncologie"
Edegem, , Belgium
"UZ Leuven Campus Gasthuisberg Digestieve Oncologie"
Leuven, , Belgium
"CHC Montlégia Oncologie"
Liège, , Belgium
"AZ NIKOLAAS Oncology"
Sint-Niklaas, , Belgium
"Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica"
Barretos, , Brazil
"Hospital de Base Centro Integrado de Pesquisa"
São José do Rio Preto, , Brazil
"ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa"
São Paulo, , Brazil
Hospital A C Camargo Unidade de Pesquisa Clinica Rua Antonio Prudente
São Paulo, , Brazil
Hospital Sao Camilo Nucleo de Pesquisa Av Alcantara Machado
São Paulo, , Brazil
Hospital Albert Einstein Instituto de Ensino e Pesquisa Av Albert Einstein
São Paulo, , Brazil
"Aalborg Universitetshospital, Syd Onkologisk Afdeling"
Aalborg, , Denmark
Rigshospitalet Dpt of Oncology
Copenhagen, , Denmark
"Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling"
Herning, , Denmark
"Odense Universitetshospital Department of Oncology"
Odense, , Denmark
"CHU Jean Minjoz Service d'oncologie médicale"
Besançon, , France
"CHU Morvan Institut de Cancérologie et d'Hématologie"
Brest, , France
"Centre de lutte contre le cancer Francois Baclesse UCP Digestif"
Caen, , France
Hôpital Saint-Antoine Service d'Oncologie Médicale
Paris, , France
"Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive"
Paris, , France
CHU de Poitiers Pole Régional de Cancérologie
Poitiers, , France
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin, , Germany
Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie
Berlin, , Germany
Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei
Lübeck, , Germany
Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III
München, , Germany
Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly
Budapest, , Hungary
Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly
Budapest, , Hungary
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly
Győr, , Hungary
Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
Kecskemét, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika
Szeged, , Hungary
JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum
Szolnok, , Hungary
Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly
Szombathely, , Hungary
Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica Strada Statale 554 Sestu-Monserrato
Cagliari, Italiy, Italy
A.O.U. Seconda Universita degli Studi di Napoli U.O.C di Oncologia Medica e di Ematologia Dipartimento Medico di Internistica clinca e sperimentale " F Magrassi - A. Lanzara" Via Sergio Pansisni ,
Napoli, , Italy
Istituto Nazionale Tumori, I.R.C.C.S "Fondazione G Pascale" Struttura Complessa di Oncologia Medica Addominale
Napoli, , Italy
Istituto Oncologico Veneto IOV - IRCCS Unita Operativa Complessa Oncologia Medica 1 Via Gattamelata 64
Padua, , Italy
A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
Pisa, , Italy
Ospedale San Carlo U.O. Oncologia Medica Via Potito Petrone, Ctr Macchia Romana
Potenza, , Italy
Arcispedale Santa Maria Nuova Unità di Oncologia
Reggio Emilia, , Italy
Istituto Clinico Humanita IRCCS Dipartimento di Oncologia Medica ed Ematologia Via Manzoni,
Rozzano (MI), , Italy
IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia Vale Cappuccini 1
San Giovanni Rotondo, , Italy
Przychodnia Lekarska "KOMED"
Konin, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii
Krakow, , Poland
Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
Opole, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
Słupsk, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii
Warsaw, , Poland
Wojskowy Instytut Medyczny Klinika Onkologii
Warsaw, , Poland
Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii
Warzszawa, , Poland
Pan American Center for Oncology Trials, LLC
Río Piedras, Porto RICO, Puerto Rico
Arkhangelsk Clinical Oncology Dispensary chemotherapy department
Arkhangelsk, , Russia
Clinical Oncology Dispensary No.1 Chemotherapy Department
Krasnodar, , Russia
Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy
Moscow, , Russia
University Headache Clinic Outpatient oncology clinic
Moscow, , Russia
Moscow City Oncology Hospital # 62 chemotherapy department
Moscow Region, , Russia
Omsk Clinical Oncologic Dispensary Chemotherapy
Omsk, , Russia
Scientific Centre for Specialized Medical Care (oncological) Chemotherapy
Saint Petersburg, , Russia
National Medical Research Center of Oncology N.N. Petrova
Saint Petersburg, , Russia
Saint Petersburg City Oncology Clilnic
Saint Petersburg, , Russia
Multidisciplinary clinic "Reaviz
Samara, , Russia
Oncology dispensary No.2 Oncology department
Sochi, , Russia
SBIH of YR "Clinical oncology hospital chemotherapy department"
Yaroslavl, , Russia
"H. Valle de Hebrón Servicio de Oncología - (VHIR)"
Barcelona, , Spain
"Hospital de la Santa Creu I Sant Pau Oncología Medica"
Barcelona, , Spain
"Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica"
Córdoba, , Spain
"INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica"
L'Hospitalet de Llobregat, , Spain
"Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica"
Madrid, , Spain
"HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica"
Madrid, , Spain
"Hospital Universitario Marqués de Valdecilla oncología medica"
Santander, , Spain
H.VIRGEN DEL ROCIO Servicio de Oncología Médica
Seville, , Spain
H. GENERAL DE VALENCIA Servicio de Oncología Médica
Valencia, , Spain
Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médical
Zaragoza, , Spain
Kyiv City Clinical Oncological Centre
Kiev, Ukrain, Ukraine
Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre
Cherkassy, , Ukraine
"MI ""Dnipropetrovsk City Multi-field Clinical Hospital #4"" Department of Oncology"
Dnipro, , Ukraine
LLC Ukrainian Center of Tomotherapy "Tomoclinic", Chemoteraphy Department
Kropyvnytskyi, , Ukraine
National Institute of Cancer Abdominal Oncology Department
Kyiv, , Ukraine
Medical Center n.a. Acad. Spizhenko "Syber Clinic Spizhenko"" Department of Oncology
Kyiv, , Ukraine
"Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology "LISOD"
Kyiv, , Ukraine
Podillia Regional Oncology Centre Chemotherapy Department
Vinnitsya, , Ukraine
Countries
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References
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Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Cruz FM, Wyrwicz L, Stroyakovskiy D, Papai Z, Poureau PG, Liposits G, Cremolini C, Bondarenko I, Modest DP, Benhadji KA, Amellal N, Leger C, Vidot L, Tabernero J; SUNLIGHT Investigators. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. doi: 10.1056/NEJMoa2214963.
Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Wyrwicz L, Stroyakovskiy D, Liposits G, Bondarenko I, Modest DP, Amellal N, Tabernero J; SUNLIGHT Investigators. Plain language summary of SUNLIGHT: trifluridine/tipiracil and bevacizumab for refractory metastatic colorectal cancer. Future Oncol. 2024;20(36):2823-2832. doi: 10.1080/14796694.2024.2366100. Epub 2024 Jul 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-001976-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CL3-95005-007
Identifier Type: -
Identifier Source: org_study_id
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