Cancer of Esophagus Clinical Trial
— HeartcheckOfficial title:
Identification of Chemo and Radiation Induced Systolic and Diastolic Myocardial Dysfunction in Patients With Cancer in Oesophagus and Gastroesophagael Junction - a Prospective Study
NCT number | NCT03619317 |
Other study ID # | 1-16-02-189-18 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 25, 2018 |
Est. completion date | March 2022 |
Introduction: Patients with cancer in esophagus and gastroesophageal junction (EGEJ) treated with chemoradiotherapy (chemoRT) have increased risk of cardiovascular disease. EGEJ patients often have frailty and pre-existing cardiovascular disease. This may disqualify them for standard trimodal curative treatment and offer surgery alone, chemoRT alone or palliative treatment only. The current understanding of radiation induced heart disease (RIHD) in EGEJ patients is limited. Hence, there is a need for additional studies. Especially on myocardial function during and after chemoRT as congestive heart failure is a serious complication associated with increased morbidity and mortality. Proton-based radiation therapy (RT) is a new alternative to standard photon-based radiation therapy, that is likely to reduce the risk of cardiovascular complications. Hypothesis: Treatment with chemoRT might induce myocardial dysfunction, symptoms of heart failure and decreased physical performance in patients with EGEJ Cancer. The aim: Is to investigate the influence on chemoRT on myocardial function in EGEJ patients and evaluate the cardiac prognosis and eventually identify potential high-risk patients who might benefit from proton-based RT instead of the current photon-based RT. Method: From power calculation the investigators plan to include 56 patients with EGEJ cancer during a period of two years. Inclusions criteria: biopsy verified EGEJ cancer supported by findings from gastroscopy, PET CT scan and with the final diagnosis locally advanced, non-metastatic. The patients will be examined with serial cardiac investigations to evaluate if they develop impairment of the heart function during or after chemoRT. The investigations include; electrocardiogram, cardiac biomarkers, echocardiography and cardio pulmonary exercise test. The examinations will be performed at study entry (baseline) and after six weeks and again after six months.
Status | Recruiting |
Enrollment | 56 |
Est. completion date | March 2022 |
Est. primary completion date | August 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Biopsy verified EGEJ cancer verified by gastroscopy, biopsy and PET/CT scan. - The final diagnosis must be locally advanced, non-metastatic as determined at a multidisciplinary team conference. - Patients referred to curative treatment with preoperative or definitive chemo- and radiotherapy. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Denmark | University Hospital of Aarhus, Department of Cardiology | Aarhus N |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital Skejby | Danish Cancer Society |
Denmark,
Beukema JC, van Luijk P, Widder J, Langendijk JA, Muijs CT. Is cardiac toxicity a relevant issue in the radiation treatment of esophageal cancer? Radiother Oncol. 2015 Jan;114(1):85-90. doi: 10.1016/j.radonc.2014.11.037. Epub 2014 Dec 30. Review. — View Citation
Chuong MD, Hallemeier CL, Jabbour SK, Yu J, Badiyan S, Merrell KW, Mishra MV, Li H, Verma V, Lin SH. Improving Outcomes for Esophageal Cancer using Proton Beam Therapy. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):488-497. doi: 10.1016/j.ijrobp.2015.11.043. Epub 2015 Dec 14. Review. — View Citation
Clemmensen TS, Eiskjær H, Mølgaard H, Larsen AH, Soerensen J, Andersen NF, Tolbod LP, Harms HJ, Poulsen SH. Abnormal Coronary Flow Velocity Reserve and Decreased Myocardial Contractile Reserve Are Main Factors in Relation to Physical Exercise Capacity in Cardiac Amyloidosis. J Am Soc Echocardiogr. 2018 Jan;31(1):71-78. doi: 10.1016/j.echo.2017.09.007. Epub 2017 Oct 27. — View Citation
Lund M, Alexandersson von Döbeln G, Nilsson M, Winter R, Lundell L, Tsai JA, Kalman S. Effects on heart function of neoadjuvant chemotherapy and chemoradiotherapy in patients with cancer in the esophagus or gastroesophageal junction - a prospective cohort pilot study within a randomized clinical trial. Radiat Oncol. 2015 Jan 13;10:16. doi: 10.1186/s13014-014-0310-7. — View Citation
Madan R, Matalon S, Vivero M. Spectrum of Smoking-related Lung Diseases: Imaging Review and Update. J Thorac Imaging. 2016 Mar;31(2):78-91. doi: 10.1097/RTI.0000000000000185. Review. — View Citation
Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Alexandru Popescu B, Waggoner AD; Houston, Texas; Oslo, Norway; Phoenix, Arizona; Nashville, Tennessee; Hamilton, Ontario, Canada; Uppsala, Sweden; Ghent and Liège, Belgium; Cleveland, Ohio; Novara, Italy; Rochester, Minnesota; Bucharest, Romania; and St. Louis, Missouri. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1321-1360. Epub 2016 Jul 15. Review. — View Citation
Nielsen KM, Offersen BV, Nielsen HM, Vaage-Nilsen M, Yusuf SW. Short and long term radiation induced cardiovascular disease in patients with cancer. Clin Cardiol. 2017 Apr;40(4):255-261. doi: 10.1002/clc.22634. Epub 2017 Jan 31. Review. — View Citation
Sjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16. — View Citation
van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088. — View Citation
Xi M, Xu C, Liao Z, Chang JY, Gomez DR, Jeter M, Cox JD, Komaki R, Mehran R, Blum MA, Hofstetter WL, Maru DM, Bhutani MS, Lee JH, Weston B, Ajani JA, Lin SH. Comparative Outcomes After Definitive Chemoradiotherapy Using Proton Beam Therapy Versus Intensity Modulated Radiation Therapy for Esophageal Cancer: A Retrospective, Single-Institutional Analysis. Int J Radiat Oncol Biol Phys. 2017 Nov 1;99(3):667-676. doi: 10.1016/j.ijrobp.2017.06.2450. Epub 2017 Jun 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | • Left ventricular systolic function estimated by 2D longitudinal strain (GLS) and ejection fraction (EF) at rest and peak exercise | where a decrease of peak GLS of 10 % is considered clinical significant. | From Baseline till 6 weeks after. | |
Secondary | • Change of NT-pro-BNP | with a double increase provided that serum level is above >300 pmol/L after ChemoRT provided e-GFR >30 ml/min. | From Baseline till 6 weeks after. | |
Secondary | • Change in TNT | 2 x upper normal value = >28 ng/l provided that Estimated glomerular filtration rate >50 ml/min. | From Baseline till 6 weeks after. | |
Secondary | • Change of peak VO2 | of 10% ml/kg/min after chemoRT compared to baseline. | From Baseline till 6 weeks after. | |
Secondary | • Change in diastolic function | defined as an increase of at least one diastolic grade | From Baseline till 6 weeks after. | |
Secondary | • Admission to hospital with clinical heart failure. | To investigate if the have had heart related admission to hospital | Baseline, after 4 weeks and 6 months. | |
Secondary | • Dead - not cancer related. | Dead that is not related to the cancer diagnosis | From Baseline till 6 weeks after. | |
Secondary | • Increased use of diuretics compared to baseline | accumulated use of thiazide, loop or aldosterone antagonists | Baseline, after 4 weeks and 6 months. | |
Secondary | • Change in use of ace-inhibitors, betablockers, digoxin and hydralazine compared to baseline. | Increased use of the drugs mentioned | From Baseline till 6 weeks after. | |
Secondary | Left ventricular systolic function estimated by 2D longitudinal strain (GLS) and ejection fraction (EF) at rest and peak exercise | where a decrease of EF 5 % (absolute) is considered clinical significant. | From Baseline till 6 weeks after. |
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