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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
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).
Secondary ID [1] 0 0
2015-004544-18
Secondary ID [2] 0 0
CL2-95005-002
Universal Trial Number (UTN)
Trial acronym
TASCO1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary outcome [2] 0 0
Duration of Response (DR)
Timepoint [2] 0 0
Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2020
Sample size
Target
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse Oncology - Camperdown
Recruitment hospital [2] 0 0
Austin Hospital Olivia Newton-John Cancer & Wellness Centre - Heidelberg
Recruitment hospital [3] 0 0
Western Health, Sunshine Hospital - Saint Albans
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital Haematology and Oncology Unit - Woodville
Recruitment postcode(s) [1] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [2] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
VIC 3021 - Saint Albans
Recruitment postcode(s) [4] 0 0
SA 5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Charleroi
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Belgium
State/province [3] 0 0
Liège
Country [4] 0 0
Brazil
State/province [4] 0 0
Barretos
Country [5] 0 0
Brazil
State/province [5] 0 0
Ijui
Country [6] 0 0
Brazil
State/province [6] 0 0
Rio de Janeiro
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Jose do Rio Preto
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Denmark
State/province [9] 0 0
Copenhagen
Country [10] 0 0
Denmark
State/province [10] 0 0
Odense
Country [11] 0 0
France
State/province [11] 0 0
Besançon
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Saint-Herblain
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Magdeburg
Country [16] 0 0
Germany
State/province [16] 0 0
Munich
Country [17] 0 0
Italy
State/province [17] 0 0
Brescia
Country [18] 0 0
Italy
State/province [18] 0 0
Genova
Country [19] 0 0
Italy
State/province [19] 0 0
Milan
Country [20] 0 0
Italy
State/province [20] 0 0
Naples
Country [21] 0 0
Italy
State/province [21] 0 0
Pisa
Country [22] 0 0
Netherlands
State/province [22] 0 0
Amsterdam
Country [23] 0 0
Netherlands
State/province [23] 0 0
Breda
Country [24] 0 0
Netherlands
State/province [24] 0 0
Eindhoven
Country [25] 0 0
Netherlands
State/province [25] 0 0
Groningen
Country [26] 0 0
Netherlands
State/province [26] 0 0
Hilversum
Country [27] 0 0
Netherlands
State/province [27] 0 0
Sittard
Country [28] 0 0
Netherlands
State/province [28] 0 0
Utrecht
Country [29] 0 0
Netherlands
State/province [29] 0 0
Venlo
Country [30] 0 0
Netherlands
State/province [30] 0 0
Zwolle
Country [31] 0 0
Poland
State/province [31] 0 0
Gdynia
Country [32] 0 0
Poland
State/province [32] 0 0
Krakow
Country [33] 0 0
Poland
State/province [33] 0 0
Warszawa
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Moscow
Country [35] 0 0
Russian Federation
State/province [35] 0 0
St Petersburg
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Cordoba
Country [38] 0 0
Spain
State/province [38] 0 0
Hospitalet de Llobregat
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Malaga
Country [41] 0 0
Spain
State/province [41] 0 0
Pamplona
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Glasgow
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Leicester
Country [44] 0 0
United Kingdom
State/province [44] 0 0
London
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Manchester
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Northwood
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Other
Name
Institut de Recherches Internationales Servier
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
ADIR, a Servier Group company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02743221
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eric Van Custem, Prof
Address 0 0
Leuven Cancer Institute, University Hospitals Leuven
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries