AzTrials
AzTrials

Refractory Metastatic Colorectal CancerPhase 3SUNLIGHTNCT04737187

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

A Phase 3 study testing Trifluridine/Tipiracil and Bevacizumab in people with Refractory Metastatic Colorectal Cancer, run by Taiho Oncology, Inc. at 99 sites in 14 countries.

Completed

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

Official record
Search all trials

Trial summary

This 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Refractory Metastatic Colorectal Cancer
What is being tested?
Trifluridine/Tipiracil and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
492 participants
Where
99 sitesin 14 countries
Study dates
25 Nov 2020to 12 Sep 2023
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

  • 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

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

99 sites in 14 countries.

99 sites in 14 countries

United States12 sites

  • City of Hope

    Duarte, California, 91010

  • Renovatio Clinical - El Paso

    El Paso, Texas, 79915

  • Mayo Clinic - FL

    Jacksonville, Florida, 32224

  • DuPage Medical Group - Joliet Oncology-Hematology Associates

    Joliet, Illinois, 60435

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Investigative Clinical Research of Indiana LLC

    Noblesville, Indiana, 46062

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Mayo Clinic - Rochester

    Rochester, New York, 55905

  • City of Hope - South Pasedena

    South Pasadena, California, 91030

  • Comprehensive Hematology Oncology

    St. Petersburg, Florida, 33709

  • City of Hope - Upland

    Upland, California, 91786

Other trials in United States

Russia12 sites

  • Arkhangelsk Clinical Oncology Dispensary chemotherapy department

    Arkhangelsk, 163045

  • Clinical Oncology Dispensary No.1 Chemotherapy Department

    Krasnodar, 350040

  • Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy

    Moscow, 115478

  • University Headache Clinic Outpatient oncology clinic

    Moscow, 121467

  • Moscow City Oncology Hospital # 62 chemotherapy department

    Moscow Region, 143423

  • Omsk Clinical Oncologic Dispensary Chemotherapy

    Omsk, 644046

  • Scientific Centre for Specialized Medical Care (oncological) Chemotherapy

    Saint Petersburg, 115478

  • National Medical Research Center of Oncology N.N. Petrova

    Saint Petersburg, 197758

  • Saint Petersburg City Oncology Clilnic

    Saint Petersburg, 198255

  • Multidisciplinary clinic "Reaviz

    Samara, 443011

  • Oncology dispensary No.2 Oncology department

    Sochi, 354057

  • SBIH of YR "Clinical oncology hospital chemotherapy department"

    Yaroslavl, 150054

Other trials in Russia

Spain10 sites

  • "H. Valle de Hebrón Servicio de Oncología - (VHIR)"

    Barcelona, 08035

  • "Hospital de la Santa Creu I Sant Pau Oncología Medica"

    Barcelona, 08041

  • "Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica"

    Córdoba, 14004

  • "INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica"

    L'Hospitalet de Llobregat, 08908

  • "Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica"

    Madrid, 28034

  • "HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica"

    Madrid, 28041

  • "Hospital Universitario Marqués de Valdecilla oncología medica"

    Santander, 39008

  • H.VIRGEN DEL ROCIO Servicio de Oncología Médica

    Seville, 41013

  • H. GENERAL DE VALENCIA Servicio de Oncología Médica

    Valencia, 46014

  • Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médical

    Zaragoza, 50009

Other trials in Spain

Italy9 sites

  • Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica Strada Statale 554 Sestu-Monserrato

    Cagliari, Italiy, 9100

  • 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 ,

    Naples, 80131

  • Istituto Nazionale Tumori, I.R.C.C.S "Fondazione G Pascale" Struttura Complessa di Oncologia Medica Addominale

    Naples, 80131

  • Istituto Oncologico Veneto IOV - IRCCS Unita Operativa Complessa Oncologia Medica 1 Via Gattamelata 64

    Padova, 35128

  • A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2

    Pisa, 56126

  • Ospedale San Carlo U.O. Oncologia Medica Via Potito Petrone, Ctr Macchia Romana

    Potenza, 85100

  • Arcispedale Santa Maria Nuova Unità di Oncologia

    Reggio Emilia, 42123

  • Istituto Clinico Humanita IRCCS Dipartimento di Oncologia Medica ed Ematologia Via Manzoni,

    Rozzano (MI), 20089

  • IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia Vale Cappuccini 1

    San Giovanni Rotondo, 71013

Other trials in Italy

Hungary8 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly

    Budapest, 1062

  • Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly

    Budapest, 1115

  • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet

    Debrecen, 4032

  • Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly

    Győr, 9024

  • Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

    Kecskemét, 6000

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika

    Szeged, 6720

  • JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum

    Szolnok, 5004

  • Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly

    Szombathely, 9700

Other trials in Hungary

Ukraine8 sites

  • Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre

    Cherkassy, 18009

  • "MI ""Dnipropetrovsk City Multi-field Clinical Hospital #4"" Department of Oncology"

    Dnipro, 49102

  • Kyiv City Clinical Oncological Centre

    Kiev, Ukrain, 03115

  • LLC Ukrainian Center of Tomotherapy "Tomoclinic", Chemoteraphy Department

    Kropyvnytskyi, 25011

  • National Institute of Cancer Abdominal Oncology Department

    Kyiv, 03022

  • Medical Center n.a. Acad. Spizhenko "Syber Clinic Spizhenko"" Department of Oncology

    Kyiv, 08112

  • "Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology "LISOD"

    Kyiv, 08720

  • Podillia Regional Oncology Centre Chemotherapy Department

    Vinnitsya, 21029

Other trials in Ukraine

Austria7 sites

  • "Medizinische Universität Graz "

    Graz, 8036

  • "Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V"

    Innsbruck, 6020

  • "Ordensklinikum Linz Barmherzige Schwestern Interne I"

    Linz, 4010

  • "Landeskrankenhaus Feldkirch Interne E"

    Rankweil, 6830

  • "Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)"

    Salzburg, 5020

  • "Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie"

    Vienna, 1090

  • "Landesklinikum Wiener Neustadt "

    Wiener Neustadt, 2700

Other trials in Austria

Poland7 sites

  • Przychodnia Lekarska "KOMED"

    Konin, 62-500

  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii

    Krakow, 31-531

  • Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

    Opole, 45-061

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

    Słupsk, 76-200

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii

    Warsaw, 02-034

  • Wojskowy Instytut Medyczny Klinika Onkologii

    Warsaw, 04-141

  • Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii

    Warzszawa, 02-507

Other trials in Poland

Brazil6 sites

  • "Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica"

    Barretos, 14784-400

  • "Hospital de Base Centro Integrado de Pesquisa"

    São José do Rio Preto, 15090-000

  • "ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa"

    São Paulo, 01246-000

  • Hospital A C Camargo Unidade de Pesquisa Clinica Rua Antonio Prudente

    São Paulo, 01509-900

  • Hospital Sao Camilo Nucleo de Pesquisa Av Alcantara Machado

    São Paulo, 03102-002

  • Hospital Albert Einstein Instituto de Ensino e Pesquisa Av Albert Einstein

    São Paulo, 05652- 900

Other trials in Brazil

France6 sites

  • "CHU Jean Minjoz Service d'oncologie médicale"

    Besançon, 25030

  • "CHU Morvan Institut de Cancérologie et d'Hématologie"

    Brest, 29200

  • "Centre de lutte contre le cancer Francois Baclesse UCP Digestif"

    Caen, 14076

  • Hôpital Saint-Antoine Service d'Oncologie Médicale

    Paris, 75012

  • "Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive"

    Paris, 75015

  • CHU de Poitiers Pole Régional de Cancérologie

    Poitiers, 86021

Other trials in France

Belgium5 sites

  • "OLV Ziekenhuis Oncology"

    Aalst, 9300

  • "Universitair Ziekenhuis Antwerpen Oncologie"

    Edegem, 2650

  • "UZ Leuven Campus Gasthuisberg Digestieve Oncologie"

    Leuven, 3000

  • "CHC Montlégia Oncologie"

    Liège, 4000

  • "AZ NIKOLAAS Oncology"

    Sint-Niklaas, 9100

Other trials in Belgium

Denmark4 sites

  • "Aalborg Universitetshospital, Syd Onkologisk Afdeling"

    Aalborg, 9000

  • Rigshospitalet Dpt of Oncology

    Copenhagen, 2100

  • "Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling"

    Herning, 7400

  • "Odense Universitetshospital Department of Oncology"

    Odense, 5000

Other trials in Denmark

Germany4 sites

  • Onkologische Schwerpunktpraxis Kurfuerstendamm

    Berlin, 10707

  • Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie

    Berlin, 13353

  • Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei

    Lübeck, 23562

  • Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III

    München, 81377

Other trials in Germany

Puerto Rico1 site

  • Pan American Center for Oncology Trials, LLC

    Río Piedras, Porto RICO, 00935

Other trials in Puerto Rico

About this study

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)

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.

Read the 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).

Being tested
Trifluridine/Tipiracil, Bevacizumab
Keywords
trifluridine/tipiracil/lonsurf, TAS102, bevacizumab, avastin, RAS status (wild type, mutant)
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Trifluridine/TipiracilDrug

    Also called TAS102, S 95005, Lonsurf

    Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest

  • BevacizumabDrug

    Also called Avastin

    administered every 2 weeks (Day 1 and Day 15)

Study groups in NCT04737187
Study groupRoleWhat they receive
Trifluridine/Tipiracil + BevacizumabExperimentalParticipants 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.
Receives: Drug: Trifluridine/Tipiracil; Drug: Bevacizumab
Trifluridine/TipiracilActive comparatorParticipants 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.
Receives: Drug: Trifluridine/Tipiracil

What is being measured

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

  1. 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. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method.

    Measured: From date of randomization to the death due to any cause or cut-off date, whichever comes first (maximum duration: up to 20 months)

  2. Survival Probability at 6 Months

    Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 6 months was reported.

    Measured: From date of randomization until 6 months post treatment

  3. Survival Probability at 12 Months

    Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 12 months was reported.

    Measured: From date of randomization until 12 months post treatment

  4. Survival Probability at 18 Months

    Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 18 months was reported.

    Measured: From date of randomization until 18 months post treatment

Secondary outcomes (9)

  1. Progression Free Survival (PFS)

    PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.

    Measured: From randomization to the date of radiological tumour progression or death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months)

  2. Probability of Participants With Progression Free Survival at 3, 6, 9 and 12 Months

    PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. In this outcome measure, data of PFS at 3 months was reported.

    Measured: From randomization until 3, 6, 9, and 12 months post treatment

  3. Overall Response Rate (ORR)

    Objective response was defined as percentage of participants who achieved complete response (CR) or partial response (PR) according to the RECIST version 1.1 and using investigator's tumour assessment. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.

    Measured: From the date of randomization to the date of documentation of progression or death due to any cause or data cut-off, whichever occurred first (i.e., up to 20 months)

  4. Percentage of Participants With Disease Control

    Disease control is defined as percentage of participants who achieved CR or PR, or stable disease (SD) as per RECIST 1.1 and using investigator's tumour assessment from the date of randomization to until disease progression or death due to any cause. As per RECIST 1.1, CR: disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions.

    Measured: From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months)

  5. Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)

    An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (time from the first dose of study treatment up to 30 days after the last dose of study treatment). TEAEs included both SAEs and non-SAEs.

    Measured: From baseline (Cycle 1 Day 1) up to 30 days after the last dose of study drug (i.e., up to 30.7 months)

  6. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): Time to Definitive Deterioration of >=10 Points in Sub-scale Scores - Kaplan-Meier Analysis

    EORTC QLQ-C30: 30 item questionnaires with 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/quality of life (QOL) subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4-point Likert scales with responses from "not at all" to "very much" and GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional \& GHS/QoL = higher level of functioning, \& higher score for symptoms scales = higher symptom burden. Time to definitive >=10 points deterioration: time from date of randomization to first deterioration in QoL score >=10 points compared to baseline with no later improvement or death due to any cause. Kaplan-Meier method was used.

    Measured: Date of randomization to first deterioration in QoL score >=10 points or death due to any cause, which ever occurred first (i.e., up to 20 months)

  7. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): Time to Definitive Deterioration of >=10 Points in the Global Health Status Score - Kaplan-Meier Analysis

    EORTC QLQ-C30: 30 item questionnaires composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/QOL subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4-point Likert scales with responses from "not at all" to "very much" and GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional \& GHS/QoL = higher level of functioning, \& higher score for symptoms scales = higher symptom burden. Time to definitive >=10 points deterioration: time from date of randomization to the first deterioration in QoL score >=10 points compared to baseline with no later improvement or death due to any cause. Kaplan-Meier method was used.

    Measured: Date of randomization to first deterioration in QoL score >=10 points or death due to any cause, which ever occurred first (i.e., up to 20 months)

  8. Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified Timepoints

    The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist in 2 sections a descriptive system comprising 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and Visual Analog Scale (VAS). Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.

    Measured: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, Cycle 12, Cycle 13 and Cycle 14

  9. Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints

    The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist of 2 sections; descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a VAS. The VAS records the respondent's self-rated health on a 20 centimeter (cm) vertical VAS; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). This information can be used as a quantitative measure of health as judged by the individual respondents.

    Measured: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, Cycle 12, Cycle 13 and Cycle 14

Timeline

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

  1. First posted3 Feb 2021
  2. Study start25 Nov 2020
  3. Primary completion19 Jul 2022
  4. Study completion12 Sep 2023

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
None (open label)
Enrolment
492 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04737187
Sponsor's protocol ID
CL3-95005-007
Other IDs
2020-001976-14
Acronym
SUNLIGHT
Status last verified
Aug 2024
First submitted
29 Jan 2021
Last updated
24 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37133585

  • 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.

    PubMed 38953855

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trifluridine/Tipiracil and Bevacizumab in people with Refractory Metastatic Colorectal Cancer, run by Taiho Oncology, Inc. at 99 sites in 14 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 7 inclusion and 17 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 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Russia, Spain, Italy, Hungary and 9 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. 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 26 Dec 2023). 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 (OS) (time frame: From date of randomization to the death due to any cause or cut-off date, whichever comes first (maximum duration: up to 20 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04737187, which also lists 2 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.

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