Wilms TumorPhase 1/2MetroWilmsNCT05384821
Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)
A Phase 1/2 study testing Vincristine, Irinotecan and Temozolomide in people with Wilms Tumor, run by Centre Oscar Lambret at 18 sites in France.
Trial summary
This is a multicenter, interventional, non-randomized study among patients with a relapsed or refractory Wilms tumor. The study will aim to assess efficacy of metronomic chemotherapy, in terms of disease control after two cycles of metronomic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 months to 17 years
- Conditions the study is for
- Wilms Tumor
- What is being tested?
- Vincristine, Irinotecan and Temozolomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 18 sitesFrance
- Study dates
- 14 Sep 2022to Oct 2028
- Phase
- Phase 1/2
- 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 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient ≥18 months old and ≤ 17 years old
- Relapsed or refractory Wilms tumor, histologically proven at diagnosis
- After at least 2 lines of chemotherapy (conventional or high dose, which may include the trial molecules) or after 1 line for high risk relapse for which there would not be any curative therapy. If 1 line for high risk relapse, the enrolment should be confirmed by coordinators.
- Radiologically measurable or evaluable disease (visible, target or non-target-lesion on MRI or CT-scan)
- Performance status: Karnofsky performance status (for patients >16 years of age) or Lansky Play score (for patients ≤16 years of age) ≥ 70%.
- Able to take oral medication or nasal gastric tube or authorized gastrostomy
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- Adequate biological criteria:
- Neutrophils > 1000/mm3 ; Platelets > 75 000/mm3
- Transaminases (ALT/ AST) ≤ 3 times ULN (or ≤ 6 times ULN if liver metastasis); total bilirubin ≤ 2 ULN (except in case of Gilbert's disease)
- Creatinine ≤ 1,5 ULN or clearance ≥ 60 mL/ min/ 1,73m2 (In case of doubt, to be confirm by assessment of cystatin )
- Females of childbearing potential must have a negative seric pregnancy test within 7 days prior to initiation of treatment.
- Sexually active patients must agree to use adequate and appropriate contraception (at least one highly effective contraception or two complementary methods of contraception), 1 month before beginning of treatment while on trial drug and for 7 months after stopping the trial drug for female patients and after 6 months for male patients.
- Written informed consent from parents/legal representative, patient, and age-appropriate assent before any trial-specific screening procedures according to national guidelines.
- Patient covered by the French "Social Security" regime
Who cannot join
- Prior history of other cancer within 5 years
- Chemotherapy or radiotherapy of target lesion within 3 weeks prior to inclusion
- Target therapy within less than 5 * half-life of the substance prior to inclusion
- Major surgery within 15 days prior to inclusion
- Presence of any NCI-CTCAE v5 grade ≥ 2 cardiac, hepatic, pulmonary or renal toxicity
- Severe myelosuppression
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- Severe peripheral neuropathy (grade ≥ 2)
- Fructose intolerance
- Inflammatory bowel chronic disease and/or intestinal obstruction
- Patients with demyelinating form of Charcot-Marie-Tooth disease
- Known active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
- Known hypersensitivity to dacarbazine (DTIC), isotretinoin or to any of the trial drugs, trial drug classes, excipients in the formulation
- Hyperlipidemia and hypervitaminosis A
- Vaccination with a live attenuated vaccine within 1 month prior to inclusion
- Pregnant or breastfeeding patients
- Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
France18 sites, 18 recruiting
- Not yet recruiting
CHU Amiens Picardie
Amiens, 80054
Leslie ANDRY, MD, +33 3 22 08 76 44, andry.leslie@chu-amiens.fr
Leslie ANDRY, MD
- Recruiting
CHU de Besancon
Besançon
Véronique LAITHIER, MD, 0381219182, vlaithier@chu-besancon.fr
Véronique LAITHIER, MD
- Recruiting
CHRU de Bordeaux Hôpital des Enfants
Bordeaux, 33076
Anne NOTZ- CARRERE, MD, +33 5 57 82 04 34, anne.notz-carrere@chu-bordeaux.fr
Anne NOTZ- CARRERE, MD
- Recruiting
CHU GRENOBLE ALPES - Hôpital COUPLE ENFANT
Grenoble, 38043
Dominique PLANTAZ, MD, +33 4 76 76 59 11, DPlantaz@chu-grenoble.fr
Dominique PLANTAZ, MD
- Recruiting
Centre Oscar Lambret
Lille, 59020
Hélène SUDOUR-BONNANGE, MD, +33 3 20 29 59 56, h-sudour@o-lambret.fr
Cyril LERVAT, MD, +33 3 20 29 59 56, c-lervat@o-lambret.fr
- Recruiting
Centre Léon Bérard
Lyon, 69373
Benoit DUMONT, MD, +33 4 69 16 65 74, Benoit.DUMONT@ihope.fr
Benoit DUMONT, MD
- Recruiting
Hôpital pour Enfants " La Timone " AP-HM
Marseille, 13005
Arnauld VERSCHUUR, MD, +33 4 91 38 86 21, arnauld.verschuur@ap-hm.fr
Arnauld Verschuur, MD
- Not yet recruiting
CHU de MONTPELLIER - Hôpital Arnaud de Villeneuve
Montpellier, 34295
Stéphanie HAOUY, MD, +33 4 67 33 65 19, s-haouy@chu-montpellier.fr
Stéphanie HAOUY, MD
- Recruiting
CHU Nantes
Nantes, 44093
Estelle THEBAUD, MD, +33 2 40 08 36 10, Estelle.THEBAUD@chu-nantes.fr
Estelle THEBAUD, MD
- Recruiting
CHU de Nice - Hôpital Archet 2
Nice, 06202
Joy BENADIBA, MD, +33 4 92 03 92 68, benadiba.j@chu-nice.fr
Joy BENADIBA, MD
- Recruiting
Hôpital Armand-TROUSSEAU
Paris, 75012
Marie Dominique TABONE, MD, +33 1 44 73 68 46, marie-dominique.tabone@aphp.fr
Marie Dominique TABONE, MD
- Recruiting
CHU Hôpital Sud
Rennes, 35203
Jacinthe BONNEAU-LAGACHERIE, MD, +33 2 99 26 59 17, Jacinthe.BONNEAU-LAGACHERIE@chu-rennes.fr
Jacinthe BONNEAU-LAGACHERIE, MD
- Recruiting
Chu Rouen
Rouen, 76000
Aude MARIE-CARDINE, MD, +33 2 32 88 81 91, Aude.Marie-Cardine@chu-rouen.fr
Aude MARIE-CARDINE, MD
- Not yet recruiting
CHU La Réunion
Saint-Denis
Yves REGUERRE, 0262906110, yves.reguerre@chu-reunion.fr
Yves REGUERRE, MD
- Recruiting
CHRU Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098
Sarah JANNIER, MD, +33 3 88 12 87 94, sarah.jannier@chru-strasbourg.fr
Sarah JANNIER, MD
- Recruiting
CHU Toulouse - Hôpital des Enfants
Toulouse, 70034
Cécile BOULANGER, MD, +33 5 34 55 75 66, boulanger.c@chu-toulouse.fr
Cécile BOULANGER, MD
- Recruiting
CHRU NANCY - Hôpital d'Enfants
Vandœuvre-lès-Nancy, 54500
Ludovic MANSUY, MD, +33 3 83 15 47 34, lu.mansuy@chru-nancy.fr
Ludovic MANSUY, MD
- Recruiting
Gustave ROUSSY
Villejuif, 94805
Claudia PASQUALINI, MD, +33 1 42 11 42 11, Claudia.pasqualini@gustaveroussy.fr
Claudia PASQUALINI, MD
About this study
Official title: Phase 1-2 Trial Evaluating Metronomic Chemotherapy in Patients With a Relapsed or Refractory Wilms Tumor
This is a multicenter, interventional, non-randomized study among patients with a relapsed or refractory Wilms tumor. The study will aim to assess efficacy of metronomic chemotherapy, in terms of disease control after two cycles of metronomic chemotherapy.
Read the detailed description
The main aim of this study is to assess efficacy of metronomic chemotherapy, in terms of disease control after two cycles of metronomic chemotherapy .
Other objectives of the study include:
- To evaluate disease control obtained with metronomic chemotherapy, in terms of progression-free survival (PFS) and overall survival (OS).
- Evaluating early response after one cycle of treatment of metronomic treatment;
- Evaluating best tumor response over the whole metronomic treatment duration;
- Evaluating safety of the proposed metronomic chemotherapy;
- Evaluating the feasibility of the proposed metronomic chemotherapy.
- To evaluate quality of life using Kindl® Quality of Life questionnaire at baseline (before start of treatment), and approximately at weeks 7 and 13 of treatment
- Conditions
- Wilms Tumor
- Being tested
- Vincristine, Irinotecan, Temozolomide, Etoposide, Cis-Retinoic acid
- Keywords
- Multidrug chemotherapy, metronomic chemotherapy, Wilms Tumor, Renal cancer
- Medical subject headings
- Wilms Tumor, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VincristineDrug
IV, D1-D22-D43 and D64
IrinotecanDrug
Oral, 5 days/week during W1,W2,W7 and W8 (D1 to D5, D8 to D12, D43 to D47, D50 to D54)
TemozolomideDrug
Oral,3 weeks in a row, twice per cycle (D1 to D21, D43 to D63)
EtoposideDrug
Oral, 3 weeks in a row, twice per cycle (D22 to D42, D64 to D84)
Cis-Retinoic acidDrug
Oral, 2 weeks in a row, thrice per cycle (D15 to D28, D43 to D56, D71 to D84)
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid | Experimental | Metronomic chemotherapy : Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid Receives: Drug: Vincristine; Drug: Irinotecan; Drug: Temozolomide; Drug: Etoposide; Drug: Cis-Retinoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control
Complete response, partial response or stable disease after 2 cycles of treatment, measured by the progression-free survival (PFS).
Measured: 6 months after inclusion
Secondary outcomes (6)
Progression-free survival
The time interval between study entry and date of progression (using RECIST 1.1)
Measured: Up to progression, an average of 1 year
Overall survival
The time interval between study entry and death from any cause
Measured: Through study completion, an average of 12 months
Tumor response
Using CT-scan or MRI imaging (using RECIST 1.1)
Measured: Immediately after each cycle of treatment, up to progression, an average of 1 year
Adverse events
The adverse events (AE) are collected to evaluate the safety of the study treatment.
Measured: Through study completion, an average of 12 months (plus 30 days)
The feasibility of evaluated therapy
assessed in terms of frequency of dose reductions or temporary stops of treatment
Measured: Through study completion, an average of 12 months
Quality of life of the patient (KindL)
Ravens-Sieberer and Bullinger Quality of Life Questionnaire will be used to measure the quality of life of the patients. The score can go from 0 to 100, and the higher score corresponds to a higher health-related quality of life
Measured: Baseline, week 7 and week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start14 Sep 2022
- Primary completionMay 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilms TumorStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène SUDOUR-BONNANGE, MD, Principal investigator, Centre Oscar LambretArnauld VERSCHUUR, MD, PhD, Principal investigator, CHU La Timone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384821
- Sponsor's protocol ID
- MetroWilms-1906
- Other IDs
- PHRC-K22-018, 2022-502687-20-00, 2021-002540-67
- Acronym
- MetroWilms
- Status last verified
- Mar 2026
- First submitted
- 8 Nov 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2 Trial Evaluating Metronomic Chemotherapy in Patients With a Relapsed or Refractory Wilms Tumor
- ClinicalTrials.gov ID
- NCT05384821
- Acronym / sponsor ID
- MetroWilms / MetroWilms-1906
- Conditions
- Wilms Tumor
- Keywords
- Multidrug chemotherapy, metronomic chemotherapy, Wilms Tumor, Renal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 20 May 2022 (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.
This is a multicenter, interventional, non-randomized study among patients with a relapsed or refractory Wilms tumor. The study will aim to assess efficacy of metronomic chemotherapy, in terms of disease control after two cycles of metronomic chemotherapy.
Detailed description
The main aim of this study is to assess efficacy of metronomic chemotherapy, in terms of disease control after two cycles of metronomic chemotherapy .
Other objectives of the study include:
- To evaluate disease control obtained with metronomic chemotherapy, in terms of progression-free survival (PFS) and overall survival (OS).
- Evaluating early response after one cycle of treatment of metronomic treatment;
- Evaluating best tumor response over the whole metronomic treatment duration;
- Evaluating safety of the proposed metronomic chemotherapy;
- Evaluating the feasibility of the proposed metronomic chemotherapy.
- To evaluate quality of life using Kindl® Quality of Life questionnaire at baseline (before start of treatment), and approximately at weeks 7 and 13 of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid | Experimental | Drug: Vincristine, Drug: Irinotecan, Drug: Temozolomide, Drug: Etoposide, Drug: Cis-Retinoic acidMetronomic chemotherapy : Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid |
Who may qualify
- Ages
- 18 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Patient ≥18 months old and ≤ 17 years old
- Relapsed or refractory Wilms tumor, histologically proven at diagnosis
- After at least 2 lines of chemotherapy (conventional or high dose, which may include the trial molecules) or after 1 line for high risk relapse for which there would not be any curative therapy. If 1 line for high risk relapse, the enrolment should be confirmed by coordinators.
- Radiologically measurable or evaluable disease (visible, target or non-target-lesion on MRI or CT-scan)
- Performance status: Karnofsky performance status (for patients >16 years of age) or Lansky Play score (for patients ≤16 years of age) ≥ 70%.
Key exclusion criteria (16 listed)
- Prior history of other cancer within 5 years
- Chemotherapy or radiotherapy of target lesion within 3 weeks prior to inclusion
- Target therapy within less than 5 * half-life of the substance prior to inclusion
- Major surgery within 15 days prior to inclusion
- Presence of any NCI-CTCAE v5 grade ≥ 2 cardiac, hepatic, pulmonary or renal toxicity
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 |
|---|---|---|
| VincristineIV, D1-D22-D43 and D64 | Drug | Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid |
| IrinotecanOral, 5 days/week during W1,W2,W7 and W8 (D1 to D5, D8 to D12, D43 to D47, D50 to D54) | Drug | Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid |
| TemozolomideOral,3 weeks in a row, twice per cycle (D1 to D21, D43 to D63) | Drug | Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid |
| EtoposideOral, 3 weeks in a row, twice per cycle (D22 to D42, D64 to D84) | Drug | Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid |
| Cis-Retinoic acidOral, 2 weeks in a row, thrice per cycle (D15 to D28, D43 to D56, D71 to D84) | Drug | Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid |
Primary outcome
Disease control
Time frame: 6 months after inclusion
Complete response, partial response or stable disease after 2 cycles of treatment, measured by the progression-free survival (PFS).
6 secondary outcomes
Progression-free survival
Time frame: Up to progression, an average of 1 year
Overall survival
Time frame: Through study completion, an average of 12 months
Tumor response
Time frame: Immediately after each cycle of treatment, up to progression, an average of 1 year
Adverse events
Time frame: Through study completion, an average of 12 months (plus 30 days)
The feasibility of evaluated therapy
Time frame: Through study completion, an average of 12 months
Quality of life of the patient (KindL)
Time frame: Baseline, week 7 and week 13
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 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Hélène SUDOUR-BONNANGE, MD principal investigator
Centre Oscar Lambret
Arnauld VERSCHUUR, MD, PhD principal investigator
CHU La Timone
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vincristine, Irinotecan and Temozolomide in people with Wilms Tumor, run by Centre Oscar Lambret at 18 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 14 inclusion and 16 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Heyman - Decoupigny (+33 (0)3 20 29 59 18, promotion@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control (time frame: 6 months after inclusion). 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 18 Mar 2026.