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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02743221
Registration number
NCT02743221
Ethics application status
Date submitted
24/02/2016
Date registered
19/04/2016
Date last updated
5/10/2021
Titles & IDs
Public title
A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy
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Scientific title
An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 Study).
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Secondary ID [1]
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2015-004544-18
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Secondary ID [2]
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CL2-95005-002
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Universal Trial Number (UTN)
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Trial acronym
TASCO1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Trifluridine/tipiracil + bevacizumab
Treatment: Drugs - Capecitabine + bevacizumab
Experimental: Trifluridine/tipiracil + bevacizumab - Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride.
Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab.
Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks.
Active Comparator: Capecitabine + bevacizumab - Capecitabine was administered at 1250 mg/m² orally BID (bis in die)on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks
Treatment: Drugs: Trifluridine/tipiracil + bevacizumab
Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
Treatment: Drugs: Capecitabine + bevacizumab
Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions.
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Timepoint [1]
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Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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As per RECIST v1.1, Complete Response (CR) was disappearance of all target lesions; Partial Response (PR) was at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ORR was the proportion of patients who presented CR or PR with confirmation at subsequent time point or at least 4 weeks later.
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Timepoint [1]
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Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
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Secondary outcome [2]
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Duration of Response (DR)
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Assessment method [2]
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The DR was calculated among patients with CR or PR as the time (months) from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first.
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Timepoint [2]
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Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)
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Secondary outcome [3]
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Disease Control Rate (DCR)
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Assessment method [3]
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DCR was the proportion of patients with confirmed CR, PR or stable disease (SD) as best overall response. SD defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD.
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Timepoint [3]
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Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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The OS was defined as the time from the date of randomisation to the date of death. If death was not confirmed, or patient was alive at study cut-off date, survival time was censored at the date of last follow-up or at the study cut-off date, whichever was earlier.
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Timepoint [4]
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Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)
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Eligibility
Key inclusion criteria
- Written informed consent obtained.
- Has ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the
time of the randomisation.
- Has definitive histologically or cytologically confirmed adenocarcinoma of the colon
or rectum.
- RAS status must have been determined (mutant or wild).
- Has at least one measurable metastatic lesion.
- No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
- Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is
allowed only if if it has been completed more than 6 months before start of study
treatment.
- Patient is not a candidate for combination chemotherapy with irinotecan or
oxaliplatin, or for curative resection of metastatic lesions.
- Is able to take medication orally (i.e., no feeding tube).
- Has adequate organ function.
- Coagulation parameters in normal limit (or in therapeutic limit for patients treated
with anticoagulant drugs).
- Women of childbearing potential must have been tested negative in a serum pregnancy
test. Female participants of childbearing potential and male participants with
partners of childbearing potential must agree to use a highly effective method of
birth control. Women and female partners using hormonal contraceptive must also use a
barrier method.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Is a pregnant or lactating female.
- Has certain serious illness or serious medical condition(s) as described in the
protocol.
- Has had certain other recent treatment e.g. major surgery, field radiation, received
investigational agent, within the specified time frames prior to randomisation.
- Has previously received Trifluridine/tipiracil or history of allergic reactions
attributed to compounds of similar composition to Trifluridine/tipiracil or any of its
excipients.
- Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption.
- Has contra-indication to bevacizumab or capecitabine.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2020
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Sample size
Target
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Accrual to date
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Final
154
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Chris O'Brien Lifehouse Oncology - Camperdown
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Recruitment hospital [2]
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Austin Hospital Olivia Newton-John Cancer & Wellness Centre - Heidelberg
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Recruitment hospital [3]
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Western Health, Sunshine Hospital - Saint Albans
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Recruitment hospital [4]
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The Queen Elizabeth Hospital Haematology and Oncology Unit - Woodville
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Recruitment postcode(s) [1]
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NSW 2050 - Camperdown
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Recruitment postcode(s) [2]
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VIC 3084 - Heidelberg
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Recruitment postcode(s) [3]
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VIC 3021 - Saint Albans
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Recruitment postcode(s) [4]
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SA 5011 - Woodville
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Recruitment outside Australia
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Belgium
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Charleroi
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Belgium
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Leuven
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Belgium
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Liège
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Brazil
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Barretos
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Brazil
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Ijui
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Brazil
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Rio de Janeiro
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Brazil
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Sao Jose do Rio Preto
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Brazil
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Sao Paulo
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Denmark
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Copenhagen
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Denmark
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Odense
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Besançon
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France
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Paris
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France
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Saint-Herblain
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Germany
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Berlin
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Germany
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Magdeburg
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Germany
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Munich
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Italy
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Brescia
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Italy
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Genova
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Italy
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Milan
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Italy
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Naples
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Italy
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Pisa
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Amsterdam
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Breda
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Eindhoven
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Groningen
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Hilversum
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Sittard
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Zwolle
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Gdynia
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Krakow
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Warszawa
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Russian Federation
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Moscow
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Russian Federation
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St Petersburg
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Barcelona
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Cordoba
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Spain
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Hospitalet de Llobregat
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Pamplona
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United Kingdom
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Glasgow
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Northwood
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Institut de Recherches Internationales Servier
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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ADIR, a Servier Group company
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of this study is to evaluate the progression-free survival (PFS) in patients
receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control
arm) as first-line treatment for unresectable metastatic colorectal cancer in patients
non-eligible for intensive therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02743221
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Eric Van Custem, Prof
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Address
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Leuven Cancer Institute, University Hospitals Leuven
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02743221
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