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Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT)

Primary Purpose

Refractory Metastatic Colorectal Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trifluridine/Tipiracil
Bevacizumab
Sponsored by
Taiho Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Metastatic Colorectal Cancer focused on measuring trifluridine/tipiracil, TAS102, bevacizumab, avastin, RAS status (wild type, mutant)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).
  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:

  1. More than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer.
  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.

Sites / Locations

  • Mayo Clinic Hospital
  • City of Hope
  • City of Hope - South Pasedena
  • City of Hope - Upland
  • Mayo Clinic - FL
  • Mount Sinai Comprehensive Cancer Center
  • Comprehensive Hematology Oncology
  • DuPage Medical Group - Joliet Oncology-Hematology Associates
  • Investigative Clinical Research of Indiana LLC
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists
  • Mayo Clinic - Rochester
  • Renovatio Clinical - El Paso
  • "Medizinische Universität Graz "
  • "Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V"
  • "Ordensklinikum Linz Barmherzige Schwestern Interne I"
  • "Landeskrankenhaus Feldkirch Interne E"
  • "Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)"
  • "Landesklinikum Wiener Neustadt "
  • "Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie"
  • "OLV Ziekenhuis Oncology"
  • "Universitair Ziekenhuis Antwerpen Oncologie"
  • "UZ Leuven Campus Gasthuisberg Digestieve Oncologie"
  • "CHC Montlégia Oncologie"
  • "AZ NIKOLAAS Oncology"
  • "Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica"
  • "Hospital de Base Centro Integrado de Pesquisa"
  • "ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa"
  • Hospital A C Camargo Unidade de Pesquisa Clinica Rua Antonio Prudente
  • Hospital Albert Einstein Instituto de Ensino e Pesquisa Av Albert Einstein
  • Hospital Sao Camilo Nucleo de Pesquisa Av Alcantara Machado
  • "Aalborg Universitetshospital, Syd Onkologisk Afdeling"
  • Rigshospitalet Dpt of Oncology
  • "Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling"
  • "Odense Universitetshospital Department of Oncology"
  • "CHU Jean Minjoz Service d'oncologie médicale"
  • "CHU Morvan Institut de Cancérologie et d'Hématologie"
  • "Centre de lutte contre le cancer Francois Baclesse UCP Digestif"
  • Hôpital Saint-Antoine Service d'Oncologie Médicale
  • "Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive"
  • CHU de Poitiers Pole Régional de Cancérologie
  • Onkologische Schwerpunktpraxis Kurfuerstendamm
  • Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie
  • Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei
  • Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III
  • Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly
  • Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly
  • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
  • Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly
  • Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika
  • JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum
  • Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly
  • Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica Strada Statale 554 Sestu-Monserrato
  • 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 ,
  • Istituto Nazionale Tumori, I.R.C.C.S "Fondazione G Pascale" Struttura Complessa di Oncologia Medica Addominale
  • Istituto Oncologico Veneto IOV - IRCCS Unita Operativa Complessa Oncologia Medica 1 Via Gattamelata 64
  • A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
  • Ospedale San Carlo U.O. Oncologia Medica Via Potito Petrone, Ctr Macchia Romana
  • Arcispedale Santa Maria Nuova Unità di Oncologia
  • Istituto Clinico Humanita IRCCS Dipartimento di Oncologia Medica ed Ematologia Via Manzoni,
  • IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia Vale Cappuccini 1
  • Przychodnia Lekarska "KOMED"
  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii
  • Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii
  • Wojskowy Instytut Medyczny Klinika Onkologii
  • Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii
  • Pan American Center for Oncology Trials, LLC
  • Arkhangelsk Clinical Oncology Dispensary chemotherapy department
  • Clinical Oncology Dispensary No.1 Chemotherapy Department
  • Moscow City Oncology Hospital # 62 chemotherapy department
  • Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy
  • University Headache Clinic Outpatient oncology clinic
  • Omsk Clinical Oncologic Dispensary Chemotherapy
  • National Medical Research Center of Oncology N.N. Petrova
  • Multidisciplinary clinic "Reaviz
  • Oncology dispensary No.2 Oncology department
  • Scientific Centre for Specialized Medical Care (oncological) Chemotherapy
  • Saint Petersburg City Oncology Clilnic
  • SBIH of YR "Clinical oncology hospital chemotherapy department"
  • "H. Valle de Hebrón Servicio de Oncología - (VHIR)"
  • "Hospital de la Santa Creu I Sant Pau Oncología Medica"
  • "Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica"
  • "INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica"
  • "Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica"
  • "HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica"
  • "Hospital Universitario Marqués de Valdecilla oncología medica"
  • H.VIRGEN DEL ROCIO Servicio de Oncología Médica
  • H. GENERAL DE VALENCIA Servicio de Oncología Médica
  • Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médical
  • Kyiv City Clinical Oncological Centre
  • Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre
  • "MI ""Dnipropetrovsk City Multi-field Clinical Hospital #4"" Department of Oncology"
  • LLC Ukrainian Center of Tomotherapy "Tomoclinic", Chemoteraphy Department
  • National Institute of Cancer Abdominal Oncology Department
  • Medical Center n.a. Acad. Spizhenko "Syber Clinic Spizhenko"" Department of Oncology
  • "Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology "LISOD"
  • Podillia Regional Oncology Centre Chemotherapy Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

trifluridine/tipiracil in combination with bevacizumab

trifluridine/tipiracil monotherapy

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival (OS)
Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause

Secondary Outcome Measures

Progression-free survival (PFS)
Progression-free survival defined as the time elapsed between the randomization and the date of radiologic tumour progression according to RECIST version 1.1 (Eisenhauer, 2009) by investigator's judgement or death from any cause, whichever comes first.
Overall response rate (ORR)
Overall response rate defined as the proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria and using investigator's tumor assessment
Disease control rate (DCR)
Disease control rate defined as the proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST version 1.1 criteria and using investigator's tumor assessment
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0, including serious adverse events (SAEs) for safety and tolerability assessment of study drug(s)
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0, including serious adverse events (SAEs)
Quality of life: EORTC QLQ-C30
Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30) module.
Quality of life: EQ-5D-5L
Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EQ-5D-5L) module.

Full Information

First Posted
January 29, 2021
Last Updated
July 12, 2023
Sponsor
Taiho Oncology, Inc.
Collaborators
Institut de Recherches Internationales Servier
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1. Study Identification

Unique Protocol Identification Number
NCT04737187
Brief Title
Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer
Acronym
SUNLIGHT
Official Title
An Open-label, Randomized, Phase III Study Comparing Trifluridine/Tipiracil in Combination With Bevacizumab to Trifluridine/Tipiracil Monotherapy in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
July 19, 2022 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.
Collaborators
Institut de Recherches Internationales Servier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.
Detailed Description
This is an international, open-label, controlled two-arm, randomised phase III study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC. The analysis will be done after 331 events are reported. In order to observe this number of events, 490 patients will be randomised (1:1) to receive trifluridine/tipiracil in combination with bevacizumab (experimental arm) or trifluridine/tipiracil monotherapy (control arm).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Metastatic Colorectal Cancer
Keywords
trifluridine/tipiracil, TAS102, bevacizumab, avastin, RAS status (wild type, mutant)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
490 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
trifluridine/tipiracil in combination with bevacizumab
Arm Type
Experimental
Arm Title
trifluridine/tipiracil monotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Trifluridine/Tipiracil
Other Intervention Name(s)
TAS102, S 95005, Lonsurf
Intervention Description
Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
administered every 2 weeks (Day 1 and Day 15)
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause
Time Frame
Approximately 12 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Progression-free survival defined as the time elapsed between the randomization and the date of radiologic tumour progression according to RECIST version 1.1 (Eisenhauer, 2009) by investigator's judgement or death from any cause, whichever comes first.
Time Frame
Approximately 12 months
Title
Overall response rate (ORR)
Description
Overall response rate defined as the proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria and using investigator's tumor assessment
Time Frame
Approximately 12 months
Title
Disease control rate (DCR)
Description
Disease control rate defined as the proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST version 1.1 criteria and using investigator's tumor assessment
Time Frame
Approximately 12 months
Title
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0, including serious adverse events (SAEs) for safety and tolerability assessment of study drug(s)
Description
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0, including serious adverse events (SAEs)
Time Frame
Approximately 12 months
Title
Quality of life: EORTC QLQ-C30
Description
Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30) module.
Time Frame
Approximately 12 months
Title
Quality of life: EQ-5D-5L
Description
Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EQ-5D-5L) module.
Time Frame
Approximately 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded). RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy. 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. Has measurable or non-measurable disease as defined by RECIST version 1.1 Is able to swallow oral tablets. Estimated life expectancy ≥12 weeks. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 Exclusion Criteria: More than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer. Pregnancy, lactating female or possibility of becoming pregnant during the study. Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation). Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease. Has severe or uncontrolled active acute or chronic infection. Has active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension. Known Hepatitis B or Hepatitis C Virus infection. Known carriers of HIV antibodies. 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. Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization. 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 Other clinically significant medical conditions. Other malignancies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Tabernero, Prof
Organizational Affiliation
Vall d'Hebron Institute of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
City of Hope - South Pasedena
City
South Pasadena
State/Province
California
ZIP/Postal Code
91030
Country
United States
Facility Name
City of Hope - Upland
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Mayo Clinic - FL
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Comprehensive Hematology Oncology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
DuPage Medical Group - Joliet Oncology-Hematology Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Investigative Clinical Research of Indiana LLC
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46062
Country
United States
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
55905
Country
United States
Facility Name
Renovatio Clinical - El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Facility Name
"Medizinische Universität Graz "
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
"Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V"
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
"Ordensklinikum Linz Barmherzige Schwestern Interne I"
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
"Landeskrankenhaus Feldkirch Interne E"
City
Rankweil
ZIP/Postal Code
6830
Country
Austria
Facility Name
"Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)"
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
"Landesklinikum Wiener Neustadt "
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
Facility Name
"Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie"
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
"OLV Ziekenhuis Oncology"
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
"Universitair Ziekenhuis Antwerpen Oncologie"
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
"UZ Leuven Campus Gasthuisberg Digestieve Oncologie"
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
"CHC Montlégia Oncologie"
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
"AZ NIKOLAAS Oncology"
City
Sint Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
"Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica"
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
"Hospital de Base Centro Integrado de Pesquisa"
City
Sao Jose Do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
"ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa"
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Hospital A C Camargo Unidade de Pesquisa Clinica Rua Antonio Prudente
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Hospital Albert Einstein Instituto de Ensino e Pesquisa Av Albert Einstein
City
Sao Paulo
ZIP/Postal Code
05652- 900
Country
Brazil
Facility Name
Hospital Sao Camilo Nucleo de Pesquisa Av Alcantara Machado
City
São Paulo
ZIP/Postal Code
03102-002
Country
Brazil
Facility Name
"Aalborg Universitetshospital, Syd Onkologisk Afdeling"
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Rigshospitalet Dpt of Oncology
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
"Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling"
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
"Odense Universitetshospital Department of Oncology"
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
"CHU Jean Minjoz Service d'oncologie médicale"
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
"CHU Morvan Institut de Cancérologie et d'Hématologie"
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
"Centre de lutte contre le cancer Francois Baclesse UCP Digestif"
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Hôpital Saint-Antoine Service d'Oncologie Médicale
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
"Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive"
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CHU de Poitiers Pole Régional de Cancérologie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Onkologische Schwerpunktpraxis Kurfuerstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei
City
Luebeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica Strada Statale 554 Sestu-Monserrato
City
Cagliari
State/Province
Italiy
ZIP/Postal Code
9100
Country
Italy
Facility Name
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 ,
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale Tumori, I.R.C.C.S "Fondazione G Pascale" Struttura Complessa di Oncologia Medica Addominale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto IOV - IRCCS Unita Operativa Complessa Oncologia Medica 1 Via Gattamelata 64
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ospedale San Carlo U.O. Oncologia Medica Via Potito Petrone, Ctr Macchia Romana
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova Unità di Oncologia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
Istituto Clinico Humanita IRCCS Dipartimento di Oncologia Medica ed Ematologia Via Manzoni,
City
Rozzano (MI)
ZIP/Postal Code
20089
Country
Italy
Facility Name
IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia Vale Cappuccini 1
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Przychodnia Lekarska "KOMED"
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
City
Słupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Wojskowy Instytut Medyczny Klinika Onkologii
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii
City
Warzszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Pan American Center for Oncology Trials, LLC
City
Río Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Arkhangelsk Clinical Oncology Dispensary chemotherapy department
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary No.1 Chemotherapy Department
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital # 62 chemotherapy department
City
Moscow Region
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
University Headache Clinic Outpatient oncology clinic
City
Moscow
ZIP/Postal Code
121467
Country
Russian Federation
Facility Name
Omsk Clinical Oncologic Dispensary Chemotherapy
City
Omsk
ZIP/Postal Code
644046
Country
Russian Federation
Facility Name
National Medical Research Center of Oncology N.N. Petrova
City
Saint-petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Multidisciplinary clinic "Reaviz
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
Oncology dispensary No.2 Oncology department
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Scientific Centre for Specialized Medical Care (oncological) Chemotherapy
City
St Petersburg
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Saint Petersburg City Oncology Clilnic
City
St Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
SBIH of YR "Clinical oncology hospital chemotherapy department"
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
"H. Valle de Hebrón Servicio de Oncología - (VHIR)"
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
"Hospital de la Santa Creu I Sant Pau Oncología Medica"
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
"Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica"
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
"INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica"
City
Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
"Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica"
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
"HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica"
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
"Hospital Universitario Marqués de Valdecilla oncología medica"
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
H.VIRGEN DEL ROCIO Servicio de Oncología Médica
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
H. GENERAL DE VALENCIA Servicio de Oncología Médica
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médical
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Kyiv City Clinical Oncological Centre
City
Kiev
State/Province
Ukrain
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
"MI ""Dnipropetrovsk City Multi-field Clinical Hospital #4"" Department of Oncology"
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
LLC Ukrainian Center of Tomotherapy "Tomoclinic", Chemoteraphy Department
City
Kropyvnytskyi
ZIP/Postal Code
25011
Country
Ukraine
Facility Name
National Institute of Cancer Abdominal Oncology Department
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Medical Center n.a. Acad. Spizhenko "Syber Clinic Spizhenko"" Department of Oncology
City
Kyiv
ZIP/Postal Code
08112
Country
Ukraine
Facility Name
"Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology "LISOD"
City
Kyiv
ZIP/Postal Code
08720
Country
Ukraine
Facility Name
Podillia Regional Oncology Centre Chemotherapy Department
City
Vinnitsya
ZIP/Postal Code
21029
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer

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