Randomized phase 3 clinical trial for patients with metastasized childhood renal tumour

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 406

Inclusion Criteria

- Children <18 years at date of diagnosis and >3months
- Patients 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 (for radiological details please refer to section 12.8).
- Metastatic childhood renal tumour must be confirmed by central review.
- Signed informed consent form(s) prior to study entry according to national guidelines and GCP guidelines
- 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 (insufficiency, malign arrhythmias)
- No pre-existing and ongoing liver function deficiency that is not controllable by substitution
Are the trial subjects under 18? yes
Number of subjects for this age range: 406
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- inability to be followed until two years after treatment
- other chemotherapy prior to enrolment
- Patient and/or parental/legal representative(s) denied randomization
- primary nephrectomy
- histology other than nephroblastoma if confirmed by upfront tumour biopsy/cutting needle biopsy
- pregnancy or lactation
- Fertile female with child bearing potential and fertile male subjects who refuse using 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).
- 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, Nejjmegen Breakage Syndrome)
- participation in other interventional trials (registration in observational non-interventional studies is acceptable)
- age at start of treatment <3 months or >18 years
- any other medical condition incompatible with the protocol treatment

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

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