A randomized controlled trial to investigate the influence of low dose radiotherapy on immune stimulatory effects in liver metastases of colorectal cancer

• Verfasst von: Reißfelder, Christoph [VerfasserIn]
• Verfasst von: Timke, Carmen [VerfasserIn]
• Verfasst von: Schmitz-Winnenthal, Friedrich Hubertus [VerfasserIn]
• Verfasst von: Rahbari, Nuh Nabi [VerfasserIn]
• Verfasst von: Koch, Moritz [VerfasserIn]
• Verfasst von: Klug, Felix [VerfasserIn]
• Verfasst von: Röder, Falk [VerfasserIn]
• Verfasst von: Edler, Lutz [VerfasserIn]
• Verfasst von: Debus, Jürgen [VerfasserIn]
• Verfasst von: Büchler, Markus W. [VerfasserIn]
• Verfasst von: Beckhove, Philipp [VerfasserIn]
• Verfasst von: Huber, Peter E. [VerfasserIn]
• Verfasst von: Weitz, Jürgen [VerfasserIn]
• Titel: A randomized controlled trial to investigate the influence of low dose radiotherapy on immune stimulatory effects in liver metastases of colorectal cancer
• Verf.angabe: Christoph Reissfelder, Carmen Timke, Hubertus Schmitz-Winnenthal, Nuh N. Rahbari, Moritz Koch, Felix Klug, Falk Roeder, Lutz Edler, Jürgen Debus, Markus W. Büchler, Philipp Beckhove, Peter E. Huber and Jürgen Weitz
• E-Jahr: 2011
• Jahr: 30 September 2011
• Umfang: 6 S.
• Fussnoten: Gesehen am 15.09.2022
• Titel Quelle: Enthalten in: BMC cancer
• Ort Quelle: London : BioMed Central, 2001
• Jahr Quelle: 2011
• Band/Heft Quelle: 11(2011), Artikel-ID 419, Seite 1-6
• ISSN Quelle: 1471-2407
• DOI: doi:10.1186/1471-2407-11-419
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: colorectal liver metastasis
• Sach-SW: low dose radiation
• Sach-SW: tumor specific T cells
• K10plus-PPN: 1816695181

Abstract

Background: Insufficient migration and activation of tumor specific effector T cells in the tumor is one of the main reasons for inadequate host anti-tumor immune response. External radiation seems to induce inflammation and activate the immune response. This phase I/II clinical trial aims to evaluate whether low dose single fraction radiotherapy can improve T cell associated antitumor immune response in patients with colorectal liver metastases. Methods/Design: This is an investigator-initiated, prospective randomised, 4-armed, controlled Phase I/II trial. Patients undergoing elective hepatic resection due to colorectal cancer liver metastasis will be enrolled in the study. Patients will receive 0 Gy, 0.5 Gy, 2 Gy or 5 Gy radiation targeted to their liver metastasis. Radiation will be applied by external beam radiotherapy using a 6 MV linear accelerator (Linac) with intensity modulated radiotherapy (IMRT) technique two days prior to surgical resection. All patients admitted to the Department of General-, Visceral-, and Transplantion Surgery, University of Heidelberg for elective hepatic resection are consecutively screened for eligibility into this trial, and written informed consent is obtained before inclusion. The primary objective is to assess the effect of active local external beam radiation dose on, tumor infiltrating T cells as a surrogate parameter for antitumor activity. Secondary objectives include radiogenic treatment toxicity, postoperative morbidity and mortality, local tumor control and recurrence patterns, survival and quality of life. Furthermore, frequencies of systemic tumor reactive T cells in blood and bone marrow will be correlated with clinical outcome. Discussion: This is a randomized controlled patient blinded trial to assess the safety and efficiency of low dose radiotherapy on metastasis infiltrating T cells and thus potentially enhance the antitumor immune response. Trial registration: ClinicalTrials.gov: NCT01191632