Nationwide clinical trial on therapy of colorectal cancer metastases
Recurrence following the removal of metastases often hampers the long-term success of treatment in patients with colorectal cancer. This is why a team of physicians, working under the auspices of Charité – Universitätsmedizin Berlin, have initiated the FIRE-9/PORT trial. The aim of this large clinical trial now starting is to investigate the efficacy of additional chemotherapy after successful treatment for metastatic disease and to establish a standard treatment. The study is funded through the German Research Foundation’s (DFG) Clinical Trials Program. It will receive an initial funding award of € 2.9 million over three years.
Colorectal cancer is one of the three most common cancers in men and women in Germany and – despite medical advances in its diagnosis and treatment – remains one of the most common causes of cancer-related deaths. Approximately half of all patients affected by the disease will develop metastases. Although these can be removed in some patients, they often recur. The current treatment strategy needs to be optimized in order to improve the long-term outcome in patients who have undergone potentially curative treatment to remove metastases – for instance from the liver or lungs. Designed to address this issue, the clinical trial entitled ‘Post-resection therapy in patients with metastatic colorectal cancer’ will set out to test the efficacy of additive chemotherapy.
“Due to the sheer size of the study, we expect the FIRE-9/PORT trial to produce highly significant results but also enormous challenges. It will be the first trial in this setting to recruit such a large number of patients in order to ask: Does active treatment help to prevent a recurrence of metastases?” explains Prof. Dr. Dominik Paul Modest, study lead and senior physician at Charité’s Department of Hematology, Oncology and Cancer Immunology on Campus Virchow-Klinikum. He adds: “This is why – regardless of outcome – the study will define a standard of care.”
The current Phase III trial aims to recruit a total of 507 patients. Over the course of six months, patients will receive chemotherapy consisting of a combination of commonly used drugs. Patients in the control group will undergo regular follow-ups but without additive treatment. Clinical findings will be further investigated via a linked translational study, which will evaluate DNA mutations and gene expression in resected cancer tissue in addition to constantly monitoring tumor markers and circulating tumor DNA. Highlighting the advantages of supplementing a clinical trial with additional research studies, Prof. Modest says: “Ideally, we will be able to define a new standard of care and, at the same time, identify which subgroups of patients are most likely or least likely to benefit from this treatment strategy.”
About the FIRE-9/PORT study
The interdisciplinary FIRE-9/PORT (Post Resection Therapy) trial is coordinated by an interdisciplinary, cross-campus research group which is led by Prof. Dr. Dominik Paul Modest and Head of Department Prof. Dr. Sebastian Stintzing, and is based at the Department of Hematology, Oncology and Cancer Immunology. Surgical expertise is provided by co-study lead Prof. Dr. Johann Pratschke, Head of the Department of Surgery, Deputy Head of Department Prof. Dr. Igor Sauer, and PD Dr. Nathanael Raschzok. Comprehensive statistical expertise and support is provided by Prof. Dr. Geraldine Rauch, Director of Charité’s Institute of Biometry and Clinical Epidemiology, and her team. Both the planning and conduct of the study (AIO KRK 0418) is being supported by the Arbeitsgemeinschaft Internistische Onkologie in der Deutschen Krebsgesellschaft e.V. (AIO), a nationwide, interdisciplinary network of more than 150 treatment centers. Operating under the aegis of the AIO, the FIRE research group has many years of experience in the implementation of large national and international clinical trials for advanced bowel cancer which have a distinct interdisciplinary focus. Founded as a colorectal cancer research group by Co-applicant Prof. Dr. Volker Heinemann, the group was initially based at the LMU’s university hospital in Munich. It later followed Prof. Stintzig and Prof. Modest to Charité, where it has operated as a cross-campus research group since 2019.
Chemotherapy for bowel cancer
As part of the FIRE-9/PORT study, patients will be treated every two weeks for a duration of six months. Patients will either receive a combination of the chemotherapy drugs Folinic acid , Fluorouracil (5-FU) and Oxaliplatin – known as the FOLFOX regimen – or the FOLFOX regimen combined with additional Irinotecan – a regimen known as FOLFOXIRI.
Prof. Dr. Dominik Paul Modest
Department of Hematology, Oncology and Cancer Immunology
Charité – Universitätsmedizin Berlin
Tel: +49 30 450 553 840
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