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

NCT04166604 | Active Not Recruiting Phase 2

• 1 other identifier: LONGBOARD C19-01
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Metastatic Colorectal Cancer

Keywords

trifluridine/ tipiracil; G-CSF; neutropenia

Outcome Measures

Primary Outcomes (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.

  At 6 months

Secondary Outcomes (7)

• Overall survival (OS)

  Up to 30 months

• Progression free survival (PFS)

  Up to 30 months

• Objective response rate (ORR)

  Up to 30 months

• Disease control rate (DCR)

  Up to 30 months

• Safety descriptive analysis

  Up to 30 months

Study Arms (1)

trifluridine/tipiracil

EXPERIMENTAL

35mg/m² BID (PER OS) (one cycle every 4 weeks)

Drug: Trifluridine/Tipiracil

Interventions

Trifluridine/Tipiracil DRUG

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

Also known as: Lonsurf

trifluridine/tipiracil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• 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,
• 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).

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (22)

CHU Amiens

Amiens, France

Location

Institut de cancérologie de l'Ouest

Angers, France

Location

CHRU Jean Minjoz

Besançon, France

Location

centre Pierre Curie

Beuvry, France

Location

Polyclinique Bordeaux Nord

Bordeaux, France

Location

Centre hospitalier de Chauny

Chauny, France

Location

Polyclinique Sainte Côme

Compiègne, France

Location

Clinique de Flandre

Coudekerque-Branche, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Centre Georges François Leclerc

Dijon, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

Hôpital Franco-Britannique

Levallois-Perret, France

Location

Hôpital Privé Jean Mermoz

Lyon, France

Location

Hôpital Européen

Marseille, France

Location

Hôpital Layne

Mont-de-Marsan, France

Location

Hôpital Nord Franche Comté

Montbéliard, France

Location

Groupe Hospitalier Pitié Sapêtrière

Paris, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital Saint Antoine

Paris, France

Location

Hôpital Haut Lévêque

Pessac, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Robert Debré

Reims, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neutropenia

Interventions

trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Jean Baptiste BACHET, MD

  Hôpital Pitié Salpêtrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 18, 2019
• Study Start: May 20, 2020
• Primary Completion: November 10, 2023
• Study Completion: November 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

FR (22)