RANDOMET 2017

Author:  JUlia Dobke, erstellt am 2021/12/15, Last modification:  2022/01/05

RANDOMET 2017

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)

Disease

Patients with metastasized childhood renal tumour

Type

International, Randomized phase 3 clinical trial 

Problem / Objectives

To determine non-inferiority of upfront 6 weeks of VCE to VAD in the overall metastatic response rate (MetRR) in newly diagnosed stage 4 WT. The MetRR will include the pulmonary response rate (PRR) and the response rate on non-pulmonary metastasis (NPRR).

Therapy / Study arms

The study includes the first 6 weeks of adjuvant chemotherapy. Thereafter follows a observation of the following chemotherapy, usually over 29 weeks.

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
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
Recruitment 406; planned recruitmenttime 6 years plus 2 years follow-up
Status Start: 1. quarter 2022
EudraCT 2018-000533-13
Entry Study Register Deutsches Krebsstudienregister: DKR-ID DRKS00021160
Principal Investigator PD Dr. Rhoikos, C.J. Furtwängler (for Germany)
E-Mail nephroblastom-studienzentrale@uks.eu
URL https://www.siop-rtsg.org
Contact

PI Germany

PD Dr. med. Rhoikos Furtwängler Universitätsklinikum des Saarlandes Klinik für Pädiatrische Hämatologie und Onkologie 66421 Homburg/Saar Telefon +49 (6841) 162 8047 Fax +49 (6841) 162 8435 rhoikos.furtwaengler@uks.eu

Trial documentation Germany

Monika Schetting Universitätsklinikum des Saarlandes Klinik für Pädiatrische Onkologie und Hämatologie Kirrberger Str. 66421 Homburg-Saar Telefon 06841/16-28025 Fax 06841/16-28024 monika.schetting@uks.eu