AzTrials
AzTrials

Metastatic Colorectal CancerPhase 2LONGBOARDNCT04166604

LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy

A Phase 2 study testing Trifluridine/Tipiracil in people with Metastatic Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 22 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Prospective cohort of patients treated with trifluridine/tipiracil, maximal sample size 250 patients. It is expected, that 89 patients will experience a grade 3-4 neutropenia and will be included in the phase II. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Trifluridine/Tipiracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
22 sitesFrance
Study dates
20 May 2020to Nov 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Signed and dated informed consent,
  • Patients willing and able to comply with protocol requirements,
  • Histologically proven colorectal adenocarcinoma,
  • Stage IV disease,
  • Have life expectancy of at least 6 months,
  • Previous chemotherapy regimens with each of the following agents: fluoropyrimidine, oxaliplatin, irinotecan, anti-vascular endothelial growth factor (VEGF) therapy (bevacizumab, aflibercept), and anti-epidermal growth factor receptor (EGFR) therapy (cetuximab or panitumumab for tumors with wild-type RAS and/or BRAF wild type),
Show all 16Show fewer
  • At least one measurable or evaluable lesion as assessed by computed tomography (CT)-scan or magnetic resonance imaging (MRI) according to RECIST v1.1,
  • Age ≥ 18 years,
  • ECOG PS 0-1,
  • Adequate hematologic function: neutrophils > 1.5 x 109 /L; platelets > 100 x 109 /L; hemoglobin ≥ 9 g/dL,
  • Calculated creatinine clearance ≥ 30 mL/min,
  • Adequate liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit normal ULN;
  • ≤ 5 x ULN in case of liver metastasis), total bilirubin ≤ 1.5 x ULN (< 2 x ULN if hyperbilirubinemia is due to Gilbert's syndrome), albumin ≥ 25 g/L,
  • Baseline evaluations: clinical and blood evaluations no more than 14 days prior to inclusion and start of trifluridine/tipiracil, Tumor assessment (CT-scan or MRI, evaluation of non-measurable lesions) no more than 21 days prior to inclusion and start of trifluridine/tipiracil,
  • Female patients must be surgically sterile, or be postmenopausal, or must commit to using reliable and appropriate methods of contraception during the study (must have a negative pregnancy test within 7 days prior to enrollment) and during at least 6 months after the end of the last dose of study treatment (when applicable). All female patients with reproductive potential must have a negative pregnancy test (β-HCG) within 72 hours prior to starting trifluridine/tipiracil treatment. Breastfeeding is not allowed. Male patients must agree to use effective contraception in addition to having their partner use a contraceptive method as well during the trial and during at least 6 months after the end of the study treatment,
  • Registration with the French National Health Care System or PUMA (Protection Universelle MAladie).

Who cannot join

  • Medical history or evidence of CNS metastasis upon physical examination, unless adequately treated (e.g. non-irradiated CNS metastasis, seizure not controlled with standard medical therapy, patients are stable without evidence of progression for at least 28 days prior to the first dose of treatment),
  • Local or locally advanced disease (stage I to III),
  • Treatment with warfarin,
  • Uncontrolled hypercalcemia,
  • Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
  • Known complete dihydropyrimidine dehydrogenase (DPD) deficiency,
Show all 14Show fewer
  • Treatment with any other investigational medicinal product within 28 days prior to study entry,
  • Symptomatic carcinomatosis with occlusive symptoms or ascites requiring paracentesis,
  • Other serious and uncontrolled non-malignant disease (e.g. active infection requiring systemic therapy, coronary stenting or myocardial infarction, or stroke in the past 6 months),
  • HIV-infected patients or otherwise known to be HIV-positive,
  • Untreated hepatitis B or C,
  • Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for > 5 years,
  • Concomitant administration of prophylactic phenytoin and live attenuated virus vaccine such as yellow fever vaccine 28 days prior to the first dose of treatment.
  • Patient under guardianship, curatorship or under the protection of justice

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

France22 sites

  • CHU Amiens

    Amiens

  • Institut de cancérologie de l'Ouest

    Angers

  • CHRU Jean Minjoz

    Besançon

  • centre Pierre Curie

    Beuvry

  • Polyclinique Bordeaux Nord

    Bordeaux

  • Centre hospitalier de Chauny

    Chauny

  • Polyclinique Sainte Côme

    Compiègne

  • Clinique de Flandre

    Coudekerque-Branche

  • Hôpital Henri Mondor

    Créteil

  • Centre Georges François Leclerc

    Dijon

  • CHD Vendée

    La Roche-sur-Yon

  • Hôpital Franco-Britannique

    Levallois-Perret

  • Hôpital Privé Jean Mermoz

    Lyon

  • Hôpital Européen

    Marseille

  • Hôpital Layne

    Mont-de-Marsan

  • Hôpital Nord Franche Comté

    Montbéliard

  • Groupe Hospitalier Pitié Sapêtrière

    Paris

  • Hôpital Cochin

    Paris

  • Hôpital Saint Antoine

    Paris

  • Hôpital Haut Lévêque

    Pessac

  • CHU Poitiers

    Poitiers

  • CHU Robert Debré

    Reims

Other trials in France

About this study

Prospective cohort of patients treated with trifluridine/tipiracil, maximal sample size 250 patients. It is expected, that 89 patients will experience a grade 3-4 neutropenia and will be included in the phase II.

Read the detailed description

Trifluridine/tipiracil has demonstrated its efficacy in patients with metastatic colorectal cancer (mCRC) resistant to standard drugs (fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and panitumumab or cetuximab in case of RAS wild-type tumors). This treatment has a marketing authorization.

Neutropenia is a classic complication of cytotoxic treatments. Febrile neutropenia are associated with a mortality rate of 9.5% and a hospitalization of 6 days in median. Recent meta-analyses have reported that the use of granulocyte-colony stimulating factor (GCSF) allows to maintain the dose-intensity of cytotoxic treatment and was associated with a better overall survival (OS).

There is currently no clear recommendation for the use of G-CSF with trifluridine/tipiracil.

Unpublished analyses that various clinical parameters may be associated with the risk of neutropenia: age ≥ 65 years, female sex, level of leukocytes at baseline, and time of initial diagnostic to randomization ≥ 36 months.These data are too preliminary to allow proposing a G-CSF primary prophylaxis in a defined subgroup of patients. However, a secondary prophylaxis based on the administration of G-CSF seems efficient, with a prescription from day 14 to day 18.

The aim of this phase II study is to assess the efficacy of the secondary prophylaxis with G-CSF in case of first episode of grade 3-4 neutropenia in the aim to maintain the optimal dose intensity.

Being tested
Trifluridine/Tipiracil
Keywords
trifluridine/ tipiracil, G-CSF, neutropenia
Medical subject headings
Colorectal Neoplasms, Neutropenia

What participants receive

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

  • Trifluridine/TipiracilDrug

    Also called Lonsurf

    After morning and evening meal

    Days 1 through 5: 35mg/m2 (twice daily)

    Days 6 through 7: recovery

    Days 8 through 12: 35mg/m2 (twice daily)

    Day 13 through 28: recovery

Study groups in NCT04166604
Study groupRoleWhat they receive
trifluridine/tipiracilExperimental35mg/m² BID (PER OS) (one cycle 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. Rate of patients free of trifluridine/tipiracil dose reduction or postponement of cycles of > 7 days at 6 months or at progression or death or stop of treatment for another cause than neutropenia if observed in 6 months.

    To assess, in mCRC patients treated with trifluridine/tipiracil after the introduction of G-CSF in a secondary prevention attempt, the rate of patients free of trifluridine/tipiracil dose reduction or postponement of cycles of > 7 days at 6 months from G-CSF first intake date or at progression or death or stop of treatment for another cause than neutropenia if observed in the 6 months.

    Measured: At 6 months

Secondary outcomes (7)

  1. Overall survival (OS)

    OS - defined as the time from study enrollment to death (from any cause) or to the last date the patients was known to be alive

    Measured: Up to 30 months

  2. Progression free survival (PFS)

    PFS - defined as the time (in months) from study enrollment until objective PD or death from any cause. If the patient dies before reaching PD, the date of death is considered as the date that PD was reached. For patients that had not reached PD at the time of the analysis, and for patients for whom the PD date is unknown, PFS is censored at the date of patient's final assessment prior to data cut-off.

    Measured: Up to 30 months

  3. Objective response rate (ORR)

    ORR - defined as proportion of patients with reduction in tumor burden of predefined amount. It refers to the number of patients with CR, PR according to RECIST v1.1

    Measured: Up to 30 months

  4. Disease control rate (DCR)

    The disease control rate (DCR) is defined as the proportion of patients in whom the best overall response is determined as complete response, partial response or stable disease

    Measured: Up to 30 months

  5. Safety descriptive analysis

    Patients will be assessed for AEs throughout the study at every visit during treatment. Investigators using the NCI-CTCAE version 5.0 will grade the severity of AEs.

    Measured: Up to 30 months

  6. The rate of dose reductions

    Number of patients for whom a dose reduction was required and the reasons for dose reduction,

    Measured: Up to 30 months

  7. Clinical or biological factors at baseline associated with the occurrence of grade 3-4 neutropenia

    Identification of clinical and biological factors at baseline associated with the occurrence of grade 3-4 neutropenia in the whole cohort and design of predictive model of neutropenia occurrence

    Measured: Up to 30 months

Timeline

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

  1. First posted18 Nov 2019
  2. Study start20 May 2020
  3. Primary completion10 Nov 2023
  4. Study completionNov 2025 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
It was planned to include 250 patients in a prospective cohort, to obtained 89 patients in the phase II (experience a grade 3-4 neutropenia)
Masking
None (open label)
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04166604
Sponsor's protocol ID
LONGBOARD C19-01
Acronym
LONGBOARD
Status last verified
Aug 2025
First submitted
4 Nov 2019
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trifluridine/Tipiracil in people with Metastatic Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 22 sites in France.

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 16 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Rate of patients free of trifluridine/tipiracil dose reduction or postponement of cycles of > 7 days at 6 months or at progression or death or stop of treatment for another cause than neutropenia if observed in 6 months. (time frame: At 6 months). 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 NCT04166604.

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 19 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in