Metastatic childhood renal tumour C64
Conditions
Interventions
Group 1: Preoperative chemotherapy with vincristine, actinomycin D and doxorubicin.
- Actinomycin D, 1 x 45 µg/kg IV day 1 in week 1, 3, 5
- Vincristine, 1 x 1,5 mg/m2 IV day 1 in week 1, 2, 3, 4, 5,
Sponsors
GPOH gGmbH
Eligibility
Sex/Gender
All
Age
3 Months to 18 Years
Inclusion criteria
Inclusion criteria: - Children 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. - 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 - 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
Exclusion criteria
Exclusion criteria: - Patient and/or parental/legal representative(s) denied study participation and randomization - inability to be followed until two years after treatment - primary nephrectomy - histology other than nephroblastoma - other chemotherapy prior to enrolment - 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). - any other medical condition incompatible with the protocol treatment - 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 non-interventional studies is acceptable) - age at start of treatment 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with radiologic complete response (CR) of any metastasis and/or Very Good Partial Response (VGPR) of lung metastasis of childhood renal tumours after 6 weeks of preoperative chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiologic response to preoperative treatment: 1. Percentage of patients after 6 weeks of preoperative chemotherapy achieving a CR after surgery of metastasis at time of nephrectomy 2. Percentage of patients with radiologic complete response (CR) of any metastasis or Very Good Partial Response (VGPR) of lung metastasis of nephroblastoma after 6 weeks of preoperative chemotherapy 3. Percentage of patients with remaining metastatic disease after surgery that achieve a CR at week 9 of adjuvant chemotherapy 4. Percentage of patients with complete response +/- VGPR of (pulmonary) metastasis of nephroblastoma after 6 weeks of preoperative chemotherapy + 9 weeks adjuvant chemotherapy. 5. Percentage of patients with complete response +/- VGPR of (pulmonary) metastasis of nephroblastoma after preoperative chemotherapy + 9 weeks adjuvant chemotherapy + metastasectomy 6. Percentage of patients with complete response +/- VGPR of (pulmonary) metastasis of nephroblastoma at the end of adjuvant chemotherapy ± metastasectomy ± RT 7. Primary tumour volume shrinkage after 6 weeks of preoperative chemotherapy 8. Primary tumour volume after 6 weeks of preoperative chemotherapy 9. Number of metastases at diagnosis and after preoperative treatment 10. Maximum diameters of the largest metastases at diagnosis and after preoperative treatment Treatment burden, complications, side effects and toxicity: 1. Percentage of patients requiring pulmonary radiotherapy in first line 2. Percentage of patients suffering from SOS during preoperative treatment according to EBMT criteria 3. Percentage of patients suffering any Grade 4 or grade 5 (CTCAE) toxicity during preoperative chemotherapy. 4. Overall duration of preoperative treatment per arm as determined as interval D1 – date of nephrectomy 5. Delay in timing of nephrectomy: % of patients with more than 8 weeks since start of preoperative chemotherapy because of toxicity 6. Percentage of (peri-)operative complications (haemorrha | — |
Countries
Austria, Belgium, Brazil, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, Vatican City
Contacts
Public ContactYvonne Braun
Universitätsklinikum des Saarlandes Klinik für Pädiatrische Onkologie und Hämatologie
Outcome results
None listed