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| Item Type: | Article |
|---|---|
| Title: | 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 |
| Creators Name: | Raschzok, N., Stintzing, S., Heinemann, V., Rauch, G., Ricke, J., Guckenberger, M., Kurreck, A., Alig, A.H.S., Stahler, A., Bullinger, L., Schmelzle, M., Schöning, W., Lurje, G., Krenzien, F., Haase, O., Rau, B., Gebauer, B., Sauer, I.M., Pratschke, J. and Modest, D.P. |
| Abstract: | BACKGROUND: Additive/adjuvant chemotherapy as concept after local treatment of colorectal metastases has not been proven to be successful by phase III 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. TRIAL REGISTRATION: This study is registered with clinicaltrials.gov ( NCT05008809 ) and EudraCT (2020-006,144-18). |
| Keywords: | Colorectal Cancer, Colorectal Metastases, Adjuvant Chemotherapy |
| Source: | BMC Cancer |
| ISSN: | 1471-2407 |
| Publisher: | BioMed Central |
| Volume: | 22 |
| Number: | 1 |
| Page Range: | 359 |
| Date: | 2 April 2022 |
| Official Publication: | https://doi.org/10.1186/s12885-022-09422-6 |
| PubMed: | View item in PubMed |
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