NCT05384821

Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

Phase 1-2 Trial Evaluating Metronomic Chemotherapy in Patients With a Relapsed or Refractory Wilms Tumor

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Months – 17 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

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

Timeline

• Start date: 2022-09-14
• Primary completion: 2028-05-01
• Completion: 2028-10-01
• First posted: 2022-05-20
• Last updated: 2026-03-18

Locations

18 sites across 1 country: France