Cerfolio RJ, Talati A, Bryant AS Changes in pulmonary function tests after neoadjuvant therapy predict postoperative complications. Ann Thorac Surg. 2009 Sep;88(3):930-5; discussion 935-6. doi: 10.1016/j.athoracsur.2009.06.013.
Derogar M, Lagergren P Health-related quality of life among 5-year survivors of esophageal cancer surgery: a prospective population-based study. J Clin Oncol. 2012 Feb 1;30(4):413-8. doi: 10.1200/JCO.2011.38.9791. Epub 2012 Jan 3.
Donohoe CL, McGillycuddy E, Reynolds JV Long-term health-related quality of life for disease-free esophageal cancer patients. World J Surg. 2011 Aug;35(8):1853-60. doi: 10.1007/s00268-011-1123-6.
Ferguson MK, Celauro AD, Prachand V Prediction of major pulmonary complications after esophagectomy. Ann Thorac Surg. 2011 May;91(5):1494-1500; discussion 1500-1. doi: 10.1016/j.athoracsur.2010.12.036.
Ferguson MK, Durkin AE Preoperative prediction of the risk of pulmonary complications after esophagectomy for cancer. J Thorac Cardiovasc Surg. 2002 Apr;123(4):661-9.
Gill PG, Denham JW, Jamieson GG, Devitt PG, Yeoh E, Olweny C Patterns of treatment failure and prognostic factors associated with the treatment of esophageal carcinoma with chemotherapy and radiotherapy either as sole treatment or followed by surgery . J Clin Oncol. 1992 Jul;10(7):1037-43. Erratum in: J Clin Oncol 1992 Nov;10(11):1822.
Hurmuzlu M, Aarstad HJ, Aarstad AK, Hjermstad MJ, Viste A Health-related quality of life in long-term survivors after high-dose chemoradiotherapy followed by surgery in esophageal cancer. Dis Esophagus. 2011 Jan;24(1):39-47. doi: 10.1111/j.1442-2050.2010.01104.x. Epub 2010 Sep 2.
Lin FC, Durkin AE, Ferguson MK Induction therapy does not increase surgical morbidity after esophagectomy for cancer. Ann Thorac Surg. 2004 Nov;78(5):1783-9. Review.
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.
Venkat P, Shridhar R, Naghavi A, et al Pathologic Complete Response and Dose Escalation with Preoperative Dose Painting IMRT Chemoradiation in Esophageal Cancer. IJROBP. 2015; 93:S219-220
Wang J, Palmer M, Bilton SD, et al Comparing Proton Beam to Intensity Modulated Radiation Therapy Planning in Esophageal Cancer. Int J Particle Ther. 2015;1:866-877.
Warren S, Partridge M, Carrington R, Hurt C, Crosby T, Hawkins MA Radiobiological determination of dose escalation and normal tissue toxicity in definitive chemoradiation therapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):423-9. doi: 10.1016/j.ijrobp.2014.06.028.
Wei X, Liu HH, Tucker SL, Wang S, Mohan R, Cox JD, Komaki R, Liao Z Risk factors for pericardial effusion in inoperable esophageal cancer patients treated with definitive chemoradiation therapy. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):707-14. doi: 10.1016/j.ijrobp.2007.10.056. Epub 2008 Jan 11.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.