SIOP RANDOMET 2017
Key facts
- Where
- Budapest és Pécs, MagyarországSee the 2 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old is the patient who may join a trial?
- What type of cancer has the patient been diagnosed with?
- Is this cancer newly diagnosed, or has it come back or not responded to treatment?
- Is the patient pregnant or breastfeeding?
Where in Magyarország
- Semmelweis UniversityBudapest, MagyarországToborzás még nem indult
- University of PecsPécs, MagyarországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GPOH gGmbH
- Trial code
- EU 2023-508926-91-00
- Record updated
- 2026. szeptember 7.
- Original description
To determine non-inferiority of preoperative 6 weeks of VCE to VAD in the overall metastatic rapid response rate (MetRR) in newly diagnosed stage 4 childhood renal tumours. The MetRR will include the pulmonary response rate (PRR) and the response rate on non-pulmonary metastasis (NPRR).Read full original descriptionShow less
Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)
To determine non-inferiority of preoperative 6 weeks of VCE to VAD in the overall metastatic rapid response rate (MetRR) in newly diagnosed stage 4 childhood renal tumours. The MetRR will include the pulmonary response rate (PRR) and the response rate on non-pulmonary metastasis (NPRR).
Inclusion: 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.
Exclusion: other chemotherapy prior to enrolment; Treated by any investigational agent in a clinical study within previous 4 weeks; pre-existing health impairment that significantly hazards the safe treatment according to the study; 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); any other medical condition incompatible with the protocol treatment; 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); age at start of treatment <3 months or >18 years; Patient and/or parental/legal representative(s) denied randomization; unwillingness to follow adequate supportive measures including transfusion of blood products if medically needed; participation in other interventional trials (registration in observational noninterventional studies is acceptable); primary nephrectomy; inability to be followed until two years after treatment; 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.