Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

Sponsor
Centre Oscar Lambret
Study ID
NCT05384821
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Wilms Tumor

Eligibility Criteria

Sex
ALL
Age
18 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Vincristine — DRUG
    IV, D1-D22-D43 and D64
  • Irinotecan — DRUG
    Oral, 5 days/week during W1,W2,W7 and W8 (D1 to D5, D8 to D12, D43 to D47, D50 to D54)
  • Temozolomide — DRUG
    Oral,3 weeks in a row, twice per cycle (D1 to D21, D43 to D63)
  • Etoposide — DRUG
    Oral, 3 weeks in a row, twice per cycle (D22 to D42, D64 to D84)
  • Cis-Retinoic acid — DRUG
    Oral, 2 weeks in a row, thrice per cycle (D15 to D28, D43 to D56, D71 to D84)

Study Details

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.

Key Dates

Start date
Sep 14, 2022
Status verified
Mar 2026
Primary completion
May 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm - Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid
    Metronomic chemotherapy : Vincristine + Irinotécan + Témozolomide + Etoposide + Cis-Retinoic acid

Primary Outcome Measure

Disease control [ Time Frame: 6 months after inclusion ]

Central Contacts

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