WHO ICTRP trial

Randomized multi-centre open-label non-inferiority phase 3 clinical trial for…

DRKS00021160 · German Clinical Trials Register · Recruiting

Key facts

Trial ID DRKS00021160
Public title 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)
Scientific title 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) - Randomet2017
Primary sponsor GPOH gGmbH
Registry German Clinical Trials Register
Recruitment status Recruiting
Study type interventional
Phase 3
Countries Austria;Belgium;Brazil;Switzerland;Czechia;Germany;Denmark;Spain;France;United Kingdom;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Portugal;Sweden;Vatican City
Conditions Metastatic childhood renal tumour C64;Malignant neoplasm of kidney, except renal pelvis
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, 6 - Doxorubicin, 1 x 50 mg/m2 6h…
Registration date May 26, 2020
Target size 406
Secondary IDs EUCT 2023-508926-91-00;2018-000533-13
Registry page drks.de

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