The CHAMP (Chemotherapy, Host response And Molecular dynamics in Periampullary cancer) study is a prospective, single-arm observational study that will start Sept 1 2018. All patients diagnosed with a histologically or cytologically confirmed diagnosis of pancreatic or other periampullary adenocarcinoma undergoing adjuvant or palliative chemotherapy treatment in the Department of Oncology, Skåne University Hospital, Malmö will be invited to participate.The estimated number of recruited patients is 90/year, 75 with pancreatic cancers. Of note tumour origin can seldom be firmly established in non-resectable cases, where only a fine needle aspiration or biopsy specimen is available before initiation of palliative chemotherapy. Main exclusion criteria are: 1. patients having another concomitant life-threatening disease and 2. patients who are unable to receive chemotherapy.
Patients will be informed about the study by their oncologist and a research nurse and, if they want to participate, will sign an informed consent form. The treatment regimen will follow national guidelines, and will not be affected by the study. Clinical and pathological data will be compiled at study entry. Radiological and clinical workup will be performed every three months. Primary endpoint will be overall survival, secondary endpoints will be disease specific survival, time to progression, and quality of life (EORTC-QLQ-PAN26). Serial sampling of blood during chemotherapy treatment will be performed by a dedicated research nurse along with the clinical routine sampling. Plasma and serum samples for analysis of ctDNA and cytokines, respectively, will be will be drawn before chemotherapy start (timepoint 0/T0), and prior to each additional course of chemotherapy (monthly e.g. gemcitabine based regimens; T1-5 or biweekly e.g. combination regimen FOLFIRINOX; T1-11), and after the last course of treatment (T6 or T12). Peripheral blood mononuclear cells (PBMC) will be isolated from buffy coat in plasma vials before start of chemotherapy (T0), before the second or third (T2/T3) (monthly or biweekly, respectively) course of chemotherapy, before the fourth or seventh (T4/T7) course of chemotherapy, and after the last course of treatment. A homepage is under construction and the study is registered with ClinicalTrials.gov
How does chemotherapy affect the dynamics of pancreatic and periampullary tumors? The truth is no one really knows. To bring us closer to an answer for this important question we have started the CHAMP (Chemotherapy, Host response And Molecular dynamics in Periampullary cancer) study which is open to patients with pancreatic cancer in Malmö since September 2018. When taking routine blood samples before courses of chemotherapy we extract a few extra ml of blood to look at molecules such as circulating tumor DNA and cytokines to see how standard chemotherapy changes tumour burden and the immune system. We will also look at biomarkers and the molecular profiling of the resected tumor or tumor biopsy to help us understand this diverse and dismal disease. A homepage is under construction where further information can be found along with a participant forum to enable discussions between participants and with pathologists and oncologists responsible for the study.