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

Raschzok, Nathanael; Stintzing, Sebastian; Heinemann, Volker; Rauch, Geraldine; Ricke, Jens; Guckenberger, Matthias; Kurreck, Annika; Alig, Annabel H. S.; Stahler, Arndt; Bullinger, Lars; Schmelzle, Moritz; Schoening, Wenzel; Lurje, Georg; Krenzien, Felix; Haase, Oliver; Rau, Beate; Gebauer, Bernhard; Sauer, Igor M.; Pratschke, Johann und Modest, Dominik P. (2022): 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. In: BMC Cancer, Bd. 22, Nr. 1, 359

Abstract

Background: Additive/adjuvant chemotherapy as concept after local treatment of colorectal metastases has not been proven to be successful by phase Ill trials. Accordingly, a standard of care to improve relapse rates and long-term survival is not established and adjuvant chemotherapy cannot be recommended as a standard therapy due to limited evidence in literature. The PORT trial aims to generate evidence that post-resection/ablation/radiation chemotherapy improves the survival in patients with metastatic colorectal cancer. Methods: Patients to be included into this trial must have synchronous or metachronous metastases of colorectal cancer-either resected (R0 or R1) and/or effectively treated by ablation or radiation within 3-10 weeks before randomization-and have the primary tumor resected, without radiographic evidence of active metastatic disease at study entry. The primary endpoint of the trial is progression-free survival after 24 months, secondary endpoints include overall survival, safety, quality of life, treatments (including efficacy) beyond study participation, translational endpoints, and others. One arm of the study comprising 2/3 of the population will be treated for 6 months with modified FOLFOXIRI or modified FOLFOX6 (investigator's choice, depending on the performance status of the patients but determined before randomization), while the other arm (1/3 of the population) will be observed and undergo scheduled follow-up computed tomography scans according to the interventional arm. Discussion: Optimal oncological management after removal of colorectal metastases is unclear. The PORT trial aims to generate evidence that additive/adjuvant chemotherapy after definitive treatment of colorectal metastases improves progression free and overall survival in patients with colorectal cancer.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• Sprache: Englisch