SIOP RANDOMET 2017
- Conditions
- Stage IV childhood renal tumour with pulmonary +/- non-pulmonarymetastasisMedDRA version: 20.0Level: PTClassification code: 10029145Term: Nephroblastoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508926-91-00
- Lead Sponsor
- GPOH gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 363
Age <18 years >3 months, Patient suffering from metastatic renal tumour at initial diagnosis having at least one circumscript, non-calcified (pulmonary) nodule (or other lesion highly suspicious of metastasis according to criteria for metastatic disease) =3 mm as determined by chest CT-scan and abdominal CT-scan/MRI. Metastatic disease must be confirmed by central review., Understand and voluntarily provide permission (subjects and when applicable, parental/legal representative(s)) to the ICF prior to conducting any study related assessments/procedures, Able to adhere to the study visit schedule and other protocol requirements, No pre-existing and ongoing cardiac malfunction disease, No pre-existing and ongoing liver function deficiency which is not controllable by substitution, Metastatic childhood renal tumour must be confirmed by central review.
Patient and/or parental/legal representative(s) denied randomization, pre-existing health impairment that significantly hazards the safe treatment according to the study, unwillingness to follow adequate supportive measures including transfusion of blood products if medically needed, inability to receive chemotherapy according to the protocol, this is particulary true for: a. acute kidney failure needing dialysis treatment b. pre-existing peripheral neuropathy, Active, uncontrolled life threatening Infection (e.g. Acute Hepatitis, Pneumonia, AIDS, Varizella), known chromosomal instability/susceptibility (e.g. Fanconi Anemia, Nijmegen Breakage Syndrome), participation in other interventional trials (registration in observational noninterventional studies is acceptable), age at start of treatment <3 months or >18 years, any other medical condition incompatible with the protocol treatment, primary nephrectomy, inability to be followed until two years after treatment, other chemotherapy prior to enrolment, other histology than nephroblastoma at diagnosis, Pregnancy or lactating, Fertile female with child bearing potential and fertile male subjects who deny the use of highly effective contraceptive measures, Treated by any investigational agent in a clinical study within previous 4 weeks, Hypersensitivity to the active substances or other excipients contained in the investigational medical products listed in the summary of product characteristics (SmPC) or Investigators Brochure (IB).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method