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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
IV, D1-D22-D43 and D64
Oral, 5 days/week during W1,W2,W7 and W8 (D1 to D5, D8 to D12, D43 to D47, D50 to D54)
Oral,3 weeks in a row, twice per cycle (D1 to D21, D43 to D63)
CHU Amiens Picardie
Amiens, France
NOT_YET_RECRUITINGCHU de Besancon
Besançon, France
Disease control
Complete response, partial response or stable disease after 2 cycles of treatment, measured by the progression-free survival (PFS).
Time frame: 6 months after inclusion
Progression-free survival
The time interval between study entry and date of progression (using RECIST 1.1)
Time frame: Up to progression, an average of 1 year
Overall survival
The time interval between study entry and death from any cause
Time frame: Through study completion, an average of 12 months
Tumor response
Using CT-scan or MRI imaging (using RECIST 1.1)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline, week 7 and week 13
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Oral, 3 weeks in a row, twice per cycle (D22 to D42, D64 to D84)
Oral, 2 weeks in a row, thrice per cycle (D15 to D28, D43 to D56, D71 to D84)
CHRU de Bordeaux Hôpital des Enfants
Bordeaux, France
RECRUITINGCHU GRENOBLE ALPES - Hôpital COUPLE ENFANT
Grenoble, France
RECRUITINGCentre Oscar Lambret
Lille, France
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGHôpital pour Enfants " La Timone " AP-HM
Marseille, France
RECRUITINGCHU de MONTPELLIER - Hôpital Arnaud de Villeneuve
Montpellier, France
NOT_YET_RECRUITINGCHU Nantes
Nantes, France
RECRUITINGCHU de Nice - Hôpital Archet 2
Nice, France
RECRUITING...and 8 more locations