Nationwide clinical study on the therapy of colorectal cancer metastases
Berlin, 21.10.2021 – Recurrences after removal of metastases often limit the successful long-term treatment of colorectal cancer. For this reason, an interdisciplinary team of doctors led by Charité – Universitätsmedizin Berlin has initiated the large-scale FIRE-9/PORT study. The aim of the clinical study, which is now starting, is to investigate the contribution of additional chemotherapy to the success of therapy in patients – after successful treatment of metastases – and to establish a standard therapy. In this way, relapses should be delayed or avoided altogether. The study is funded by the „Clinical Studies“ programme of the German Research Foundation (DFG) with 2.9 million euros initially for three years.
Colorectal cancer refers to malignant tumours of the intestine – mostly so-called colorectal carcinomas. Bowel cancer is one of the three most common cancers in men and women in Germany and – despite all the progress in diagnosis and treatment – remains one of the most common causes of cancer-related death. About half of those affected suffer metastasis during the course of the disease. The resulting tumour metastases can be removed – if detected early enough – but they often recur. In order to improve the healing prospects of patients in the long term after the removal of metastases – for example from the liver or the lungs – an optimisation of the therapy strategy is necessary. The clinical study entitled „Additive therapy after removal of metastases from colorectal carcinoma“ starts here to investigate the effectiveness of supportive chemotherapy.
„We expect the FIRE-9/PORT study to have significant power due to its size, but also to be very challenging. It will be the first study to address such a large number of patients with this question: What is the optimal treatment to prevent new metastases from developing?“, explains Prof. Dr. Dominik Paul Modest, head of the study and senior physician at the Medical Clinic with a focus on haematology, oncology and tumour immunology at the Campus Virchow-Klinikum of the Charité. „In this respect, the study – regardless of the outcome – will point to a future standard of care.“
A total of 507 patients will be included in the current phase III trial. They will either receive chemotherapeutic treatment with a combination of common drugs over six months, or will be regularly monitored oncologically in the control group without supportive treatment. An accompanying translational study will support the clinical findings. For this purpose, DNA mutations and gene expression in the removed tumours will be characterised, and tumour markers and tumour DNA circulating in the blood will be continuously examined. Prof. Modest points out the advantages of such a combination of clinical trial and accompanying research: „In this way, we can ideally establish a standard of treatment and at the same time identify the subgroups of patients who benefit most or least from the therapy strategy.“
About the FIRE-9/PORT study
The interdisciplinary FIRE-9/PORT (Post Resection Therapy) study at the Charité is coordinated by the inter-site and interdisciplinary study group headed by Prof. Dr. Dominik Paul Modest and the clinic directors Prof. Dr. Sebastian Stintzing and Prof. Dr. Johann Pratschke. From the Surgical Clinic of the Charité, in addition to Prof. Pratschke, the deputy clinic director Prof. Dr. Igor Sauer and private lecturer Dr. Nathanael Raschzok are also involved. The comprehensive statistical evaluation is being carried out by the team led by Prof. Dr. Geraldine Rauch, Director of the Institute for Biometry and Clinical Epidemiology at the Charité. The planning and implementation of the study is also supported by the Arbeitsgemeinschaft Internistische Onkologie in der Deutschen Krebsgesellschaft e.V. (AIO). (AIO) (AIO KRK 0418), a national, interdisciplinary network of over 150 treatment centres. The FIRE study group, based in the AIO, has many years of experience in the implementation of large national and international clinical trials on advanced colorectal cancer with an interdisciplinary focus. The study group was founded at the Ludwig-Maximilians-University (LMU) Munich Hospital as a colorectal cancer programme by Prof. Dr Volker Heinemann, who is also co-applicant on the project, and has been managed from both sites since 2019 following the move of Prof Stintzing and Prof Modest to the Charité.
Chemotherapy of colorectal cancer
In the FIRE-9/PORT study, patients will receive treatment every fortnight for six months that includes the chemotherapeutic drugs folinic acid, fluorouracil (5-FU) and oxaliplatin (FOLFOX) or combined with additional irinotecan (FOLFOXIRI).