Ongoing projects / research:
NeoRes II, Scandinavian multicenter randomized study. The aim is to compare effect of waiting after chemoradiotherapy (CROSS regimen) prior to resection for 4-6 versus 10-12 weeks relative to degree of pathological response, morbidity and survival. Inclusion of patients (about 90 in each arm), in its final phase. All centers in Norway participate (Oslo, Bergen, Trondheim, Tromsø)
There is a continual monitoring of complications and survival (quality assurance) following resection for esophageal- and gastric cancer
A biobank has been established since August 2013, and about 450 patients has been recruited (esophageal cancer (n= 260), gastric cancer (n=190)) with biological material (blood samples and tumor specimens). A major aim is to do research on potential biomarkes than can discriminate malignant from non-malignant alterations, to be used as an aid in treatment of these patients. Analyses of biobank material will be performed in the spring of 2018.
In EURECCA project 1 the aim is to compare outcome (treatment strategy, mortality, survival) in patients aged 65 or more with resectable esophageal and gastric cancer between 5 different European countries (Norway, Sweden, Belgium, Netherlands, Switzerland). Data from cancer registries in respective countries will be merged and analysed for the period 2004-14.
In EURECCA project 2 the aim is to compare treatment strategy and outcome i patients with metastastatic gastric cancer (st IV=M1) with regard to proportion of resections, chemotherapy, no therapy and survival. A manuscript has been sent for consideration to British J Surgery in February 2018.
The INNOVATION study. European randomised multicenter study, in which patients with HER-2 positive gastric cancer were randomized in three arms for i) chemotherapy, ii) chemotherapy with trastuzumab or iii) chemotherapy with trastuzumab+pertuzumab. End point is overall survival. EORTC study. Inclusion is still ongoing.
Keynote 061 (randomised study with palliative chemmotherapi in 2. line for gastric cancer; standard chemotherapy vs. MK3475. MSD study. Inclusion from August 2015.
Keynote 180 (phase II study, palliative chemotherapy in 3. line for esophageal cancer; MK3474). MSD study. Inclusion from January 2016.
Keynote 181 (randomised phase III study, palliative chemoterapy in 2. line for esophageal cancer; standard chemotherapy vs MK3475). MSD study. Inclusion from January 2016.
Nordic NEC registry (registry study for all patients with neuroendocrine carcinoma of the GI-tract (GEP-NEC)). Inclusion from 2013. NNTG (Nordic Neuroendocrine Tumor Group). See reference 3 in the publication list (GO Hjortland is co-author).
ET-NEC. Nordic one armed phase II study for patients with GEP-NEC, Ki67 index 20-55%, first line treatment with everolimus and temozolomid. Inclusion from October 2014. NNTG study.
Vitamin- and nutritional status, gastrointestinal complaints and QoL after resection or gastrectomy for gastric cancer. Inclusion completed 2018. A master`s thesis by Lisa C. Kolbjørnsen with the title “Nutritional status two to five years following gastrectomy for gastric cancer – A cross sectional study”, was published in 2017 (http://www.duo.uio.no). Another nutritional student is in the process of writing a master`s about QoL in these patients. The aim is ultimately to publish the data in peer reviewed journal.
Planned research / long term objectives for the group:
A study aiming at evaluation of security and side-effects by combining immunotherapy with a PD-1 inhibitor and radiation therapy in patients with esophageal cancer (INEC studien).
One long-term objective for the group is to explore molecular changes in esophageal- and gastric cancer and seek for potential tumor and blood derived biomarkers than can facilitate early discovery of premalignant and malignant changes in these patients. Accordingly, early detection of such changes would improve the treatment result because of identification of an early stage of the cancer. In addition, biomarkers could be used to monitor effect of neoadjuvant and adjuvant treatment and a recurrence could be potentially discovered in a treatable stage of the cancer.
Continual monitoring of complications is also crucial in order to alter the treatment strategy of these patients. Rate of anastomotic leakage is a major problem after esophageal resection, and postoperative routines that can reduce the risk for leakage must have a high priority.
Anastomotic leakage after esophageal resection for cancer –microcirculatory changes in the
gastric tube and thoracic esophagogastric anastomosis.
Purpose: to study microcirculatory changes in the gastric tube before, under and after surgery for esophageal cancer. Study examinations: clinical examination, CT-angiography of mesenterial vessels, laser doppler flowmetry, light spectrophotometry and endoscopic duplex ultrasound. LDF, LS and EDU also performed by gastroscopy. Patient population: 15 Study period: 6 mths. (2018)
Main investigators: Nathkai Safi and Simen Tveten Berge under the supervision of Syed SH Kazmi, PhD/senior consultant of the Dept. of Vascular Surgery of the Oslo University Hospital. Cooperative investigators: Jonny Hisdal, PhD/physiology Dept. of Vascular Surgery, Asle W. Medhus, PhD/Head of Dept. of Gastroenterology and Hans-Olaf Johannessen, PhD/Senior Consultant Dept. of Gastrointestinal Surgery. Application to REC was sent primo February-18.