Description for experts
To demonstrate the non-inferiority of 6 weeks of preoperative chemotherapy with VCE compared to chemotherapy with AVD based on the early overall metastatic response rate (MetRR) in newly diagnosed stage 4 paediatric renal tumours (equivalence test). The MetRR includes the pulmonary response rate (PRR) and the non-pulmonary metastatic response rate (NPRR).
The entire clinical trial comprises the 6-week preoperative therapy. This is followed by observation of further treatment, which usually lasts 29 weeks (2 weeks perioperative phase and 27 weeks of therapy).
Description for laymen
JSON Data
{
"short_title": "SIOP RANDOMET 2017",
"data_mode": "900",
"data_mode_number": "000002459",
"official_title": "Randomisierte, multizentrische, offene, Phase III, \u00c4quivalenzstudie (non-inferiority) f\u00fcr Patienten mit Nierentumor des Kindesalters im Stadium IV zum Vergleich der pr\u00e4operativen Chemotherapie bestehend aus Vincristin, Actinomycin \u2013 D und Doxorubicin (VAD, Standardarm) mit der pr\u00e4operativen Chemotherapie bestehend aus Vincristin, Carboplatin und Etoposid (VCE, Vergleichsarm)",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "kurativ",
"therapieintervention_value": null,
"therapielinie_value": "first",
"ctgov_number": null,
"eudract_number": "2018-000533-13",
"general_contact_email": "Kik-dokuteam-hs65@ukdd.de",
"general_contact_phone": "+49 351-4585035",
"hauptpruefer_dd_name": "Prof. Dr. med. Ralf Kn\u00f6fler",
"description_laie_de": "Zum Nachweis der \u00c4quivalenz (non-inferiority) einer 6 w\u00f6chigen pr\u00e4operativen Chemotherapie mit VCE gegen\u00fcber einer Chemotherapie mit AVD anhand der fr\u00fchen Gesamtansprechrate bei Metastasen (MetRR) in neu diagnostizierten kindlichen Nierentumoren des Stadiums 4 (\u00c4quivalenztest). Die MetRR umfasst die pulmonale Ansprechrate (PRR) und die Ansprechrate bei nichtpulmonaler Metastasierung (NPRR).\r\n\r\nDie gesamte klinische Pr\u00fcfung umfasst die 6 \u2013 w\u00f6chige pr\u00e4operative Therapie. Hieran schlie\u00dft sich eine Beobachtung der weiteren Behandlung an, die in der Regel 29 Woche dauert (2 Wochen perioperative Phase und 27 Wochen Therapie).",
"description_laie_en": null,
"description_expert_de": null,
"description_expert_en": "To demonstrate the non-inferiority of 6 weeks of preoperative chemotherapy with VCE compared to chemotherapy with AVD based on the early overall metastatic response rate (MetRR) in newly diagnosed stage 4 paediatric renal tumours (equivalence test). The MetRR includes the pulmonary response rate (PRR) and the non-pulmonary metastatic response rate (NPRR).\r\n\r\nThe entire clinical trial comprises the 6-week preoperative therapy. This is followed by observation of further treatment, which usually lasts 29 weeks (2 weeks perioperative phase and 27 weeks of therapy).",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "III",
"main_cat_id": 14,
"sub_cat_id": 63
}
