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Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LS-SCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02990780

Recruitment Status : Recruiting

First Posted : December 13, 2016

Last Update Posted : December 11, 2019

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Sponsor:

Information provided by (Responsible Party):

Xiaolong Fu, Shanghai Chest Hospital

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Recruiting
Estimated Primary Completion Date :	December 2020
Estimated Study Completion Date :	June 2021

Publications:

Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44.

Bayman NA, Sheikh H, Kularatne B, Lorigan P, Blackhall F, Thatcher N, Faivre-Finn C. Radiotherapy for small-cell lung cancer-Where are we heading? Lung Cancer. 2009 Mar;63(3):307-14. doi: 10.1016/j.lungcan.2008.06.013. Epub 2008 Aug 3. Review.

Stinchcombe TE, Gore EM. Limited-stage small cell lung cancer: current chemoradiotherapy treatment paradigms. Oncologist. 2010;15(2):187-95. doi: 10.1634/theoncologist.2009-0298. Epub 2010 Feb 9. Review.

Mamdani H, Induru R, Jalal SI. Novel therapies in small cell lung cancer. Transl Lung Cancer Res. 2015 Oct;4(5):533-44. doi: 10.3978/j.issn.2218-6751.2015.07.20. Review.

Semenova EA, Nagel R, Berns A. Origins, genetic landscape, and emerging therapies of small cell lung cancer. Genes Dev. 2015 Jul 15;29(14):1447-62. doi: 10.1101/gad.263145.115. Review.

Pietanza MC, Byers LA, Minna JD, Rudin CM. Small cell lung cancer: will recent progress lead to improved outcomes? Clin Cancer Res. 2015 May 15;21(10):2244-55. doi: 10.1158/1078-0432.CCR-14-2958. Review.

Kalemkerian GP. Advances in pharmacotherapy of small cell lung cancer. Expert Opin Pharmacother. 2014 Nov;15(16):2385-96. doi: 10.1517/14656566.2014.957180. Epub 2014 Sep 26. Review.

Pignon JP, Arriagada R, Ihde DC, Johnson DH, Perry MC, Souhami RL, Brodin O, Joss RA, Kies MS, Lebeau B, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med. 1992 Dec 3;327(23):1618-24.

Warde P, Payne D. Does thoracic irradiation improve survival and local control in limited-stage small-cell carcinoma of the lung? A meta-analysis. J Clin Oncol. 1992 Jun;10(6):890-5.

Xia B, Chen GY, Cai XW, Zhao JD, Yang HJ, Fan M, Zhao KL, Fu XL. The effect of bioequivalent radiation dose on survival of patients with limited-stage small-cell lung cancer. Radiat Oncol. 2011 May 19;6:50. doi: 10.1186/1748-717X-6-50.

De Ruysscher D, Pijls-Johannesma M, Vansteenkiste J, Kester A, Rutten I, Lambin P. Systematic review and meta-analysis of randomised, controlled trials of the timing of chest radiotherapy in patients with limited-stage, small-cell lung cancer. Ann Oncol. 2006 Apr;17(4):543-52. Epub 2005 Dec 12. Review.

De Ruysscher D, Pijls-Johannesma M, Bentzen SM, Minken A, Wanders R, Lutgens L, Hochstenbag M, Boersma L, Wouters B, Lammering G, Vansteenkiste J, Lambin P. Time between the first day of chemotherapy and the last day of chest radiation is the most important predictor of survival in limited-disease small-cell lung cancer. J Clin Oncol. 2006 Mar 1;24(7):1057-63.

Xia B, Chen GY, Cai XW, Zhao JD, Yang HJ, Fan M, Zhao KL, Fu XL. Is involved-field radiotherapy based on CT safe for patients with limited-stage small-cell lung cancer? Radiother Oncol. 2012 Feb;102(2):258-62. doi: 10.1016/j.radonc.2011.10.003. Epub 2011 Nov 5.

van Loon J, De Ruysscher D, Wanders R, Boersma L, Simons J, Oellers M, Dingemans AM, Hochstenbag M, Bootsma G, Geraedts W, Pitz C, Teule J, Rhami A, Thimister W, Snoep G, Dehing-Oberije C, Lambin P. Selective nodal irradiation on basis of (18)FDG-PET scans in limited-disease small-cell lung cancer: a prospective study. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):329-36. doi: 10.1016/j.ijrobp.2009.04.075. Epub 2009 Sep 24.

Kies MS, Mira JG, Crowley JJ, Chen TT, Pazdur R, Grozea PN, Rivkin SE, Coltman CA Jr, Ward JH, Livingston RB. Multimodal therapy for limited small-cell lung cancer: a randomized study of induction combination chemotherapy with or without thoracic radiation in complete responders; and with wide-field versus reduced-field radiation in partial responders: a Southwest Oncology Group Study. J Clin Oncol. 1987 Apr;5(4):592-600.

Liengswangwong V, Bonner JA, Shaw EG, Foote RL, Frytak S, Eagan RT, Jett JR, Richardson RL, Creagan ET, Su JQ. Limited-stage small-cell lung cancer: patterns of intrathoracic recurrence and the implications for thoracic radiotherapy. J Clin Oncol. 1994 Mar;12(3):496-502.

Miller KL, Marks LB, Sibley GS, Clough RW, Garst JL, Crawford J, Shafman TD. Routine use of approximately 60 Gy once-daily thoracic irradiation for patients with limited-stage small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):355-9.

Turrisi AT 3rd, Kim K, Blum R, Sause WT, Livingston RB, Komaki R, Wagner H, Aisner S, Johnson DH. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999 Jan 28;340(4):265-71.

Choi NC, Herndon JE 2nd, Rosenman J, Carey RW, Chung CT, Bernard S, Leone L, Seagren S, Green M. Phase I study to determine the maximum-tolerated dose of radiation in standard daily and hyperfractionated-accelerated twice-daily radiation schedules with concurrent chemotherapy for limited-stage small-cell lung cancer. J Clin Oncol. 1998 Nov;16(11):3528-36.

Overgaard J, Hansen HS, Specht L, Overgaard M, Grau C, Andersen E, Bentzen J, Bastholt L, Hansen O, Johansen J, Andersen L, Evensen JF. Five compared with six fractions per week of conventional radiotherapy of squamous-cell carcinoma of head and neck: DAHANCA 6 and 7 randomised controlled trial. Lancet. 2003 Sep 20;362(9388):933-40. Erratum in: Lancet. 2003 Nov 8;362(9395):1588.

Bese NS, Hendry J, Jeremic B. Effects of prolongation of overall treatment time due to unplanned interruptions during radiotherapy of different tumor sites and practical methods for compensation. Int J Radiat Oncol Biol Phys. 2007 Jul 1;68(3):654-61. Epub 2007 Apr 30. Review.

Videtic GM, Fung K, Tomiak AT, Stitt LW, Dar AR, Truong PT, Yu EW, Vincent MD, Kocha WI. Using treatment interruptions to palliate the toxicity from concurrent chemoradiation for limited small cell lung cancer decreases survival and disease control. Lung Cancer. 2001 Aug-Sep;33(2-3):249-58.

Xia B, Hong LZ, Cai XW, Zhu ZF, Liu Q, Zhao KL, Fan M, Mao JF, Yang HJ, Wu KL, Fu XL. Phase 2 study of accelerated hypofractionated thoracic radiation therapy and concurrent chemotherapy in patients with limited-stage small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):517-23. doi: 10.1016/j.ijrobp.2014.09.042. Epub 2014 Dec 3.

Hou JM, Krebs MG, Lancashire L, Sloane R, Backen A, Swain RK, Priest LJ, Greystoke A, Zhou C, Morris K, Ward T, Blackhall FH, Dive C. Clinical significance and molecular characteristics of circulating tumor cells and circulating tumor microemboli in patients with small-cell lung cancer. J Clin Oncol. 2012 Feb 10;30(5):525-32. doi: 10.1200/JCO.2010.33.3716. Epub 2012 Jan 17.

Hou JM, Greystoke A, Lancashire L, Cummings J, Ward T, Board R, Amir E, Hughes S, Krebs M, Hughes A, Ranson M, Lorigan P, Dive C, Blackhall FH. Evaluation of circulating tumor cells and serological cell death biomarkers in small cell lung cancer patients undergoing chemotherapy. Am J Pathol. 2009 Aug;175(2):808-16. doi: 10.2353/ajpath.2009.090078. Epub 2009 Jul 23.

Hiltermann TJN, Pore MM, van den Berg A, Timens W, Boezen HM, Liesker JJW, Schouwink JH, Wijnands WJA, Kerner GSMA, Kruyt FAE, Tissing H, Tibbe AGJ, Terstappen LWMM, Groen HJM. Circulating tumor cells in small-cell lung cancer: a predictive and prognostic factor. Ann Oncol. 2012 Nov;23(11):2937-2942. doi: 10.1093/annonc/mds138. Epub 2012 Jun 11.