Actively Recruiting
Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer
Led by UNICANCER · Updated on 2025-12-10
73
Participants Needed
21
Research Sites
187 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
S
Servier
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test the safety of the trifluridine/tipiracil as replacement of fluoropyrimidines based chemotherapy as first line metastatic colorectal or gastroesophageal cancer regimens in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. The main questions it aims to answer are: * Is this alternative chemotherapy option a better option in term of safety for this type of patients? * Does the combination of treatments improves the overall safety? * Does the combination of treatments improves the progression-free survival, overall survival, objective response rate and disease control rate? * Does the combination of treatment have an effect on quality of life? Participants will: * Receive the trifluridine/tipiracil with oxaliplatin every 14 days, associated with: * Panitumumab or bevacizumab for colorectal adenocarcinomas * Nivolumab or trastuzumab for gastroesophageal adenocarcinomas. * Have a CT-Scan every 2 months until disease progression * Complete Health-related quality of life questionnaire every 2 months for a maximum of 6 months * Participate to the optional translational research: Blood samples fo DPYD genotyping and pharmacokinetic analysis
CONDITIONS
Official Title
Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Histological or cytological diagnosis of colorectal or gastroesophageal adenocarcinoma
- Metastatic colorectal or gastroesophageal cancer
- At least one measurable lesion per RECIST v1.1
- No prior metastatic disease therapy
- Known DPD deficiency with plasma uracil concentration ng/ml confirmed
- Age 18 years or older
- ECOG performance status 0 or 1
- Adequate bone marrow, kidney, and liver function within 7 days before treatment
- Negative pregnancy test for women of reproductive potential
- Agreement to use contraception during and up to 7 months after study
- Willingness and ability to follow study visits and procedures
- Affiliation to Social Security System or equivalent
You will not qualify if you...
- Other cancers within 5 years except certain treated cancers
- Radiotherapy within 28 days before treatment
- Active serious heart disease
- Uncontrolled high blood pressure
- Ongoing infection grade 2 or higher
- Known HIV infection
- Chronic hepatitis B or C infection
- Seizure disorder requiring medication
- Symptomatic brain or meningeal tumors
- History of organ transplant
- Allergy to study drugs
- Peripheral neuropathy > grade 1 if treated with oxaliplatin
- Recent major surgery or injury if treated with bevacizumab
- History of bleeding events if treated with bevacizumab
- Interstitial lung disease with symptoms if treated with trastuzumab, panitumumab, or bevacizumab
- Inability to swallow oral medication
- Uncontrolled malabsorption
- Pregnant or breastfeeding women
- Inability or unwillingness to comply with follow-up
- Participation in another investigational study within 30 days
- Dependence on sponsor or investigator
- Legal incapacity or protective custody status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
CHU Amiens
Amiens, France, 80054
Not Yet Recruiting
2
Institut de Cancérologie de l'Ouest
Angers, France, 49055
Not Yet Recruiting
3
Institut du Cancer d'Avignon
Avignon, France, 84918
Active, Not Recruiting
4
CHU Jean Minjoz
Besançon, France, 25000
Active, Not Recruiting
5
Centre Hospitalier de Cholet
Cholet, France, 49300
Active, Not Recruiting
6
Centre Georges François Leclerc
Dijon, France, 21079
Withdrawn
7
Hôpital Privé Jean Mermoz
Lyon, France, 69008
Active, Not Recruiting
8
Institut Régional du Cancer de Montpellier - ICM Val d'Aurelle
Montpellier, France, 34298
Actively Recruiting
9
Hôpital Saint Louis
Paris, France, 75010
Active, Not Recruiting
10
Hôpital Saint Antoine
Paris, France, 75012
Actively Recruiting
11
Hôpital Cochin
Paris, France, 75014
Active, Not Recruiting
12
Hôpital des Diaconesses Croix Saint Simon
Paris, France, 75960
Active, Not Recruiting
13
Hospices Civils de Lyon
Pierre-Bénite, France, 69495
Active, Not Recruiting
14
CHU de Poitiers
Poitiers, France, 86000
Active, Not Recruiting
15
CHU de REIMS
Reims, France, 51092
Active, Not Recruiting
16
Institut Godinot
Reims, France, 51100
Actively Recruiting
17
Institut de Cancérologie de l'Ouest - Site René Gauducheau
Saint-Herblain, France
Withdrawn
18
CHU Saint-Etienne
Saint-Priest-en-Jarez, France, 42270
Active, Not Recruiting
19
CH de Saint-Malo
St-Malo, France, 35403
Active, Not Recruiting
20
Hôpital Nord Franche-Comté / Site du Mittan
Trévenans, France, 90400
Active, Not Recruiting
21
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Active, Not Recruiting
Research Team
E
Emilie BRUMENT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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