Öffentliches Studienregister des CCC-München

Studie AIO KRK-0116 / FIRE-4.5

Studie Studiendesign Status Ein-/Auschlusskriterien Therapie Teilnehmer Dokumente Berechtigungen Tumorboards

Studie
World
Studienakronym
:
AIO KRK-0116 / FIRE-4.5
World
Vollständiger Titel
:

Randomised study to investigate FOLFOXIRI plus cetuximab vs. FOLFOXIRI plus bevacizumab as first-line treatment of BRAF-mutated metastatic colorectal cancer

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EudraCT-Nr.
:
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Zuständige Einrichtung
:
KUM - Med3 - Medizinische Klinik und Poliklinik III Lmu
Krankheitsentitäten
Klassifikation Code Beschreibung
ICD-10-GM C18.- Bösartige Neubildung des Kolons
ICD-10-GM C19 Bösartige Neubildung am Rektosigmoid, Übergang
ICD-10-GM C20 Bösartige Neubildung des Rektums
Studiendesign
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Studientyp
:
Interventionsstudie
World
Verblindungstyp
:
Offen
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Studienphase
:
II
Status
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Status
:
Rekrutierung aktiv
Voten
World
Ethikkommission - Votum
:
Positiv
Initiierung & Abschluß
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Abschlussdatum (Plan / Ist)
:
Unbekannt / Unbekannt
Therapie
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Therapielinie
:
1
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Therapie
:

Arm A: FOLFOXIRI plus bevacizumab
One cycle (cycle duration 14 days) consists of:
Irinotecan 150 mg/m² iv, 30 - 90 min. day 1
Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1
Oxaliplatin 85mg/m² day 1
5-FU 3000 mg/m² iv over 48 h days 1-2
Bevacizumab 5 mg/kg BW iv over 30 to 90* minutes: day 1
Repeat administration every 2 weeks for a maximum of 12 cycles

Arm B: FOLFOXIRI plus cetuximab
One cycle (cycle duration 14 days) consists of:
Irinotecan 150 mg/m² iv, 30 - 90 min. day 1
Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1
oxaliplatin 85mg/m² day 1
5-FU 3000 mg/m² iv over 48 h day 1-2
Cetuximab initially 400 mg/m² with infusion rate ≤5 mg/min., subsequently 250 mg/m² iv with infusion rate of ≤10 mg/min. days 1+8
Repeat administration every 2 weeks for a maximum of 12 cycles
Recommended maintenance treatment (after a maximum of 12 cycles in both study arms; no longer study medication)
Arm A
FUFA plus bevacizumab
One cycle (cycle duration 21 days) consists of:
Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1
5-FU 400 mg/m² bolus day 1
5-FU 2400 mg/m² iv over 46 h day 1-2
Bevacizumab 7.5 mg/kg BW iv over 30 to 90 minutes: day 1
Or alternatively
Capecitabine plus bevacizumab
One cycle (cycle duration 21 days) consists of:
Capecitabine 1250 mg/m2 2 x day p.o. day 1-14
Bevacizumab 7.5 mg/kg BW i.v over 30 to 90 minutes: day 1
Repeat administration every three weeks until progression or occurrence of unacceptable toxicity
Arm B
Irinotecan and cetuximab
Cycle length 14 days until progression or emergence of unacceptable toxicity:
Irinotecan 150 mg/m² iv, 30 - 90 min. day 1
Cetuximab 250 mg/m² iv as a 60 min. infusion (≤10 mg/min.) days 1 + 8
Repeat administration every two weeks until progression or occurrence of unacceptable toxicity
Or alternatively
FUFA and cetuximab
One cycle (cycle duration 14 days) consists of:
Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1
5-FU 400 mg/m² bolus day 1
5-FU 2400 mg/m² iv over 46 h day 1-2
Cetuximab 250 mg/m² iv as a 60 min. infusion (≤10 mg/min.) days 1 + 8
Repeat administration every two weeks until progression or occurrence of unacceptable toxicity

Teilnehmer
Funktion Vorname Nachname Einrichtung
World Verantwortlicher Ansprechpartner Volker Heinemann KUM - Med3 - Medizinische Klinik und Poliklinik III Magnifier