Metastatic Colorectal CancerPhase 2TRIFLUOX-DPNCT06245356
Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer
A Phase 2 study testing Lonsurf, Oxaliplatin and Panitumumab in people with Metastatic Colorectal Cancer and Metastatic Gastroesophageal Adenocarcinoma, run by UNICANCER at 21 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Metastatic Gastroesophageal Adenocarcinoma, DPD Deficiency
- What is being tested?
- Lonsurf, Oxaliplatin and Panitumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 21 sitesFrance
- Study dates
- 21 Mar 2025to 21 Oct 2028
- 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
- Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.
- Histological or cytological documentation of adenocarcinoma of the colon or rectum or gastroesophageal cancer (lower oesophagus, gastroesophageal junction and gastric)
- Synchronous or metachronous metastatic colorectal or gastroesophageal cancer
- Presence of at least one measurable lesion according to RECIST v1.1
- No prior therapy for metastatic disease
- known DPD deficiency defined as plasma uracil concentration≥16 ng/ml For plasma uracil concentration [16-20[ ng/ml, plasma uracil dosage must be repeated in the 7 days to confirm that plasma uracil concentration ≥16 ng/ml. If the second result is different (i.e; uracil concentration <16 ng/ml), keep the favourable result, and do not include the patient if only the first plasma uracil concentration≥16 ng/ml.
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- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate bone marrow, renal and liver functions as evidenced by the following laboratory requirements within 7 days prior to study treatment initiation:
- Absolute neutrophil count (ANC) ≥ 1,500/ mm³ without biologic response modifiers such as granulocyte colony-stimulating factor (G-CSF), within 21 days before the start of study treatment
- Platelet count ≥100,000/mm³, without platelet transfusion within 21 days before the start of study treatment
- Hemoglobin (Hb) ≥9 g/dL, without blood transfusion or erythropoietin within 21 days before the start of study treatment
- Serum creatinine ≤1.5 x upper limit of normal (ULN)
- Glomerular filtration rate as assessed by the estimated glomerular filtration rate (eGFR) ≥50 mL/min per 1.73 m² calculated by the Modification of Diet in Renal Disease (MDRD) abbreviated formula
- Total bilirubin ≤ 1.5 x ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)
- Alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5.0 x ULN for patients with liver involvement for their cancer and/or bone metastases)
- International normalized ratio (INR) ≤1.5 or prothrombin time (PT) ≤1.5 x ULN Note: Patients on stable dose (dose has not been changed in at least 28 days) of anticoagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and PTT / aPTT test results are compatible with the acceptable benefit-risk ratio at the investigator's discretion. In such case, limits as noted would not apply
- For women of reproductive potential, negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test obtained within 7 days before the start of study treatment. Women not of reproductive potential are female patients who are postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy)
- For women of childbearing potential and men, agreement to use an adequate contraception for the duration of study participation and up to 7 months following completion of therapy.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Affiliation to the Social Security System (or equivalent).
Who cannot join
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal or gastroesophageal cancer within 5 years prior to study inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)]
- Radiotherapy within 28 days prior to first dose of treatment
- Active cardiac disease including any of the following:
- Symptomatic Congestive heart failure ≥New York Heart Association (NYHA) class 3 or 4
- Severe Unstable angina (angina symptoms at rest)
- Myocardial infarction less than 12 months before first dose of treatment
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- Uncontrolled hypertension (Systolic blood pressure ≥140 mmHg or diastolic pressure ≥ 90 mmHg) despite optimal medical management.
- Ongoing infection ≥Grade 2 (NCI CTCAE v.5.0)
- Known history of human immunodeficiency virus (HIV) infection
- Chronic hepatitis B or C infection (if hepatitis status cannot be obtained from medical records, re-testing is required)
- Seizure disorder requiring medication
- Symptomatic metastatic brain or meningeal tumours
- History of organ allograft
- Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products
- In case of planned treatment with oxaliplatin: Peripheral neuropathy >Grade 1 (NCI CTCAE v.5.0)
- In case of planned treatment with bevacizumab: Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose of treatment
- In case of planned treatment with bevacizumab: Evidence or history of any bleeding diathesis, irrespective of severity. Any hemorrhage or bleeding event ≥CTCAE v 5.0 Grade 3 within 4 weeks prior to the start of study medication
- In case of planned treatment with trastuzumab or panitumumab or bevacizumab: Interstitial lung disease with ongoing signs and symptoms
- Inability to swallow oral medication
- Any uncontrolled malabsorption condition
- Pregnant or breast-feeding subjects. Women of childbearing potential must have a serum pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of study drug
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, substance abuse, medical or psychological reasons, or any condition that, in the opinion of the investigator, would interfere with the patient's participation in the study or evaluation of study treatment or interpretation of patient safety or study results
- Participation in another clinical study with an investigational product during the last 30 days before inclusion
- Patients who might be interconnected with or dependent on the sponsor site or the investigator
- Persons deprived of their liberty or under protective custody or guardianship, or legal incapacity or limited legal capacity
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
France21 sites, 5 recruiting
- Not yet recruiting
CHU Amiens
Amiens, 80054
Vincent HAUTEFEUILLE, MD
- Not yet recruiting
Institut de Cancérologie de l'Ouest
Angers, 49055
Victor SIMMET, MD
- Active, not recruiting
Institut du Cancer d'Avignon
Avignon, 84918
- Active, not recruiting
CHU Jean Minjoz
Besançon, 25000
- Active, not recruiting
Centre Hospitalier de Cholet
Cholet, 49300
- Withdrawn
Centre Georges François Leclerc
Dijon, 21079
- Active, not recruiting
Hôpital Privé Jean Mermoz
Lyon, 69008
- Recruiting
Institut Régional du Cancer de Montpellier - ICM Val d'Aurelle
Montpellier, 34298
Emmanuelle SAMALIN, MD
- Active, not recruiting
Hôpital Saint Louis
Paris, 75010
- Recruiting
Hôpital Saint Antoine
Paris, 75012
Daniel LOPEZ, MD
- Active, not recruiting
Hôpital Cochin
Paris, 75014
- Active, not recruiting
Hôpital des Diaconesses Croix Saint Simon
Paris, 75960
- Active, not recruiting
Hospices Civils de Lyon
Pierre-Bénite, 69495
- Active, not recruiting
CHU de Poitiers
Poitiers, 86000
- Active, not recruiting
CHU de REIMS
Reims, 51092
- Recruiting
Institut Godinot
Reims, 51100
Damien BOTSEN, MD
- Withdrawn
Institut de Cancérologie de l'Ouest - Site René Gauducheau
Saint-Herblain
- Active, not recruiting
CHU Saint-Etienne
Saint-Priest-en-Jarez, 42270
- Active, not recruiting
CH de Saint-Malo
St-Malo, 35403
- Active, not recruiting
Hôpital Nord Franche-Comté / Site du Mittan
Trévenans, 90400
- Active, not recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
Official title: TRIFLUOX-DP: Safety of Trifluridine/Tipiracil as Replacement of Fluoropyrimidines (5-fluorouracil and Capecitabine) Based Chemotherapy as First Line Metastatic Colorectal or Gastroesophageal Cancer Regimens in Patients With Dihydropyrimidine Dehydrogenase Deficiency: a Phase II Trial
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:
Read more
- 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
- Being tested
- Lonsurf, Oxaliplatin, Panitumumab, Bevacizumab, Trastuzumab
- Keywords
- Metastatic colorectal cancer, Metastatic Gastroesophageal Adenocarcinoma, DPD Deficiency, Trifluridine/Tipiracil
- Medical subject headings
- Colorectal Neoplasms, Dihydropyrimidine Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LonsurfDrug
Trifluridine/tipiracil orally 35 mg/m²/dose (D1-D5 twice daily, D1=D15)
OxaliplatinDrug
Oxaliplatin intravenous injection 85 mg/m² every 2 weeks (D1=D15)
PanitumumabDrug
Panitumumab intravenous injection 6 mg/kg (D1=D15)
BevacizumabDrug
Bevacizumab intravenous injection 5 mg/kg (D1=D15)
TrastuzumabDrug
Trastuzumab intravenous injection 4 mg/kg (D1=D15)
NivolumabDrug
Nivolumab intravenous injection 240 mg (D1=D15)
| Study group | Role | What they receive |
|---|---|---|
| Colorectal adenocarcinoma | Other | Trifluridine/tipiracil in association with oxaliplatin with or without:
* Panitumumab in RAS wild type tumors
* Bevacizumab in RAS wild type of right colon or RAS mutated tumors Receives: Drug: Lonsurf; Drug: Oxaliplatin; Drug: Panitumumab; Drug: Bevacizumab |
| Gastroesophageal adenocarcinoma | Other | Trifluridine/tipiracil in association with oxaliplatin with or without:
* Trastuzumab in HER2-positive tumors (3+ IHC or 2+/FISH+)
* Nivolumab if CPS≥5 and HER2-negative tumors Receives: Drug: Lonsurf; Drug: Oxaliplatin; Drug: Trastuzumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment specific safety
The percentage of patients without specific toxicities defined as grade 3-4-5 digestive toxicities (diarrhoea and/or stomatitis) and grade 4-5 neutropenia or febrile neutropenia over the first 2 cycles of first-line metastatic treatment.
Toxicities will be graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5), widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Measured: 1 month
Secondary outcomes (9)
Overall Safety
All types of toxicities occuring during the study. The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Measured: Throughout study completion, up to 2 years
Compliance with study treatment
Patients will record Trifluridine/tipiracil intake within a leaflet every day. Investigators will collect this data at every on site visit during the first 2 cycles (before Cycle 3).
Measured: 1 month
Progression Free Survival
The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
Measured: From baseline until disease progression or death, up to 2 years
Overall Survival
The overall survival is the length of time from baseline that patients enrolled in the study are still alive.
Measured: From baseline until disease progression or death, up to 2 years
Objective response rate
The objective response rate is defined as the percentage of patients with a complete response (CR) or a partial response (PR) for a given treatment.
Measured: From baseline until disease progression, up to 2 years
Disease control rate
The disease control rate is defined as the percentage of patients with a CR, a PR or stable disease for a given treatment.
Measured: From baseline until disease progression, up to 2 years
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At baseline, 2 months, 4 months, and 6 months
Quality of life questionnaire - Oesophago-Gastric (QLQ-OG25)
This EORTC oesophago-gastric cancer specific questionnaire is intended to supplement the QLQ-C30.
The QLQ-OG25 contains 25 items organized into six scales: dysphagia (three items), eating restrictions (four items), reflux (two items), odynophagia (two items), pain and discomfort (two items) and anxiety (two items), and ten single items: eating in front of others, dry mouth, trouble with taste, body image, trouble swallowing saliva, choked when swallowing, trouble with coughing, trouble talking, weight loss and hair loss. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.
Measured: At baseline, 2 months, 4 months, and 6 months
Quality of life questionnaire - Colorectal (QLQ-CR29)
This EORTC colorectal cancer specific questionnaire is intended to supplement the QLQ-C30.
The QLQ-CR29 has 5 functional and 18 symptom scales. It contains 29 items organized into four subscales: urinary frequency (two items), blood and mucus in stool (two items), stool frequency (two items), and body image (three items), and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest, impotence, sexual interest, and dyspareunia). All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Measured: At baseline, 2 months, 4 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start21 Mar 2025
- Primary completion22 Oct 2026 (estimated)
- Study completion21 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Servier
- Responsible party
- Sponsor
- Investigators
- Emmanuelle SAMALIN, MD, Principal investigator, Institut du Cancer de Montepllier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245356
- Sponsor's protocol ID
- PRODIGE 91 - UCGI 46
- Acronym
- TRIFLUOX-DP
- Status last verified
- Dec 2025
- First submitted
- 29 Jan 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIFLUOX-DP: Safety of Trifluridine/Tipiracil as Replacement of Fluoropyrimidines (5-fluorouracil and Capecitabine) Based Chemotherapy as First Line Metastatic Colorectal or Gastroesophageal Cancer Regimens in Patients With Dihydropyrimidine Dehydrogenase Deficiency: a Phase II Trial
- ClinicalTrials.gov ID
- NCT06245356
- Acronym / sponsor ID
- TRIFLUOX-DP / PRODIGE 91 - UCGI 46
- Keywords
- Metastatic colorectal cancer, Metastatic Gastroesophageal Adenocarcinoma, DPD Deficiency, Trifluridine/Tipiracil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Servier
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 22 Oct 2026 (estimated)
- Study completion
- 21 Oct 2028 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal adenocarcinoma | Other | Drug: Lonsurf, Drug: Oxaliplatin, Drug: Panitumumab, Drug: BevacizumabTrifluridine/tipiracil in association with oxaliplatin with or without: * Panitumumab in RAS wild type tumors * Bevacizumab in RAS wild type of right colon or RAS mutated tumors |
| Gastroesophageal adenocarcinoma | Other | Drug: Lonsurf, Drug: Oxaliplatin, Drug: Trastuzumab, Drug: NivolumabTrifluridine/tipiracil in association with oxaliplatin with or without: * Trastuzumab in HER2-positive tumors (3+ IHC or 2+/FISH+) * Nivolumab if CPS≥5 and HER2-negative tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.
- Histological or cytological documentation of adenocarcinoma of the colon or rectum or gastroesophageal cancer (lower oesophagus, gastroesophageal junction and gastric)
- Synchronous or metachronous metastatic colorectal or gastroesophageal cancer
- Presence of at least one measurable lesion according to RECIST v1.1
- No prior therapy for metastatic disease
Key exclusion criteria (25 listed)
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal or gastroesophageal cancer within 5 years prior to study inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)]
- Radiotherapy within 28 days prior to first dose of treatment
- Active cardiac disease including any of the following:
- Uncontrolled hypertension (Systolic blood pressure ≥140 mmHg or diastolic pressure ≥ 90 mmHg) despite optimal medical management.
- Ongoing infection ≥Grade 2 (NCI CTCAE v.5.0)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LonsurfTrifluridine/tipiracil orally 35 mg/m²/dose (D1-D5 twice daily, D1=D15) | Drug | Colorectal adenocarcinoma, Gastroesophageal adenocarcinoma |
| OxaliplatinOxaliplatin intravenous injection 85 mg/m² every 2 weeks (D1=D15) | Drug | Colorectal adenocarcinoma, Gastroesophageal adenocarcinoma |
| PanitumumabPanitumumab intravenous injection 6 mg/kg (D1=D15) | Drug | Colorectal adenocarcinoma |
| BevacizumabBevacizumab intravenous injection 5 mg/kg (D1=D15) | Drug | Colorectal adenocarcinoma |
| TrastuzumabTrastuzumab intravenous injection 4 mg/kg (D1=D15) | Drug | Gastroesophageal adenocarcinoma |
| NivolumabNivolumab intravenous injection 240 mg (D1=D15) | Drug | Gastroesophageal adenocarcinoma |
Primary outcome
Treatment specific safety
Time frame: 1 month
The percentage of patients without specific toxicities defined as grade 3-4-5 digestive toxicities (diarrhoea and/or stomatitis) and grade 4-5 neutropenia or febrile neutropenia over the first 2 cycles of first-line metastatic treatment. Toxicities will be graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5), widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
9 secondary outcomes
Overall Safety
Time frame: Throughout study completion, up to 2 years
Compliance with study treatment
Time frame: 1 month
Progression Free Survival
Time frame: From baseline until disease progression or death, up to 2 years
Overall Survival
Time frame: From baseline until disease progression or death, up to 2 years
Objective response rate
Time frame: From baseline until disease progression, up to 2 years
Disease control rate
Time frame: From baseline until disease progression, up to 2 years
Quality of life questionnaire - Core 30 (QLQ-C30)
Time frame: At baseline, 2 months, 4 months, and 6 months
Quality of life questionnaire - Oesophago-Gastric (QLQ-OG25)
Time frame: At baseline, 2 months, 4 months, and 6 months
Quality of life questionnaire - Colorectal (QLQ-CR29)
Time frame: At baseline, 2 months, 4 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuelle SAMALIN, MD principal investigator
Institut du Cancer de Montepllier
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lonsurf, Oxaliplatin and Panitumumab in people with Metastatic Colorectal Cancer and Metastatic Gastroesophageal Adenocarcinoma, run by UNICANCER at 21 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 22 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Contact Emilie BRUMENT (+33(0)6 68 32 03 59, e-brument@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment specific safety (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025.