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)

Phase 3

Recruiting

• Conditions: Metastatic childhood renal tumour; C64; Malignant neoplasm of kidney, except renal pelvis

• Registration Number: DRKS00021160
• Lead Sponsor: GPOH gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: 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.
- 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

- 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 <3 months or >18 years

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.