Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)

Phase 3 Recruiting 507 enrolled Dominik Paul Modest German Research Foundation · collab Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with metastatic colorectal cancer after definite interventional therapy of all lesions are randomized in a 2:1 fashion (favoring active therapy) to investigate the efficacy, patient reported quality of life and safety of mFOLFOXIRI/mFOLFOX-6 as additive treatment (Arm A) versus active follow-up/surveillance (Arm B).

Timeline

Start: 2021-12-06
Primary completion: 2027-11
Completion: 2030-11

Publications

Raschzok N, Stintzing S, Heinemann V, Rauch G, Ricke J, Guckenberger M, Kurreck A, Alig AHS, Stahler A, Bullinger L, Schmelzle M, Schoning W, Lurje G, Krenzien F, Haase O, Rau B, Gebauer B, Sauer IM, Pratschke J, Modest DP. FIRE-9 - PORT / AIO-KRK-0418: a prospective, randomized, open, multicenter Phase III trial to investigate the efficacy of adjuvant/additive chemotherapy in patients with definitely-treated metastatic colorectal cancer. BMC Cancer. 2022 Apr 2;22(1):359. doi: 10.1186/s12885-022-09422-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Irinotecan	Small molecule	150 mg/m2	Intravenous
Subject	Irinotecan	Small molecule	180 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	2400 mg/m2	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous

Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)

Summary

Timeline

Publications

Drugs

Indications