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CompletedNCT05604950Updated Nov 3, 2022

Surgery Versus Non-surgical Treatment for Esophageal Squamous Cell Carcinoma in Patients Older Than 70 Years

An observational study in Esophageal Squamous Cell Carcinoma, Esophagectomy and Radiotherapy, sponsored by Yongtao Han. Completed. Open to participants aged 70 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-03.

Sponsored by Yongtao Han · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
2
Ages
70 Years to 100 Years
Sex
All
01

Study summary

To determine whether older patients who underwent esophagectomy had better outcome survival than those who were non-surgically treated.

02

Conditions studied

  • Esophageal Squamous Cell Carcinoma
  • Esophagectomy
  • Radiotherapy
  • Chemotherapy
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 2 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Yongtao Han is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Data were obtained from the Sichuan Cancer Hospital \& Institute Esophageal Cancer Case Management and the department of radiation oncology multicenter databases. We retrospectively analyzed esophageal squamous cell carcinoma patients who were 70 years or older, who underwent esophagectomy or radiotherapy/chemotherapy from January 2009 to December 2017. Patients were divided into two groups: surgery and non-surgery groups. We then prospectively collected data on 284 patients with esophageal squamous cell carcinoma in the Sichuan Cancer Hospital for results verification.

Inclusion criteria

  1. Pathology confirmed ESCC,
  2. Patients with esophagectomy or radiotherapy (RT)/chemotherapy (CT),
  3. Age ≥ 70.

Exclusion criteria

Exclusion Criteria:

  1. Having other malignant tumours,
  2. Missing of required data.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
2 participants (actual)
Target follow-up
60 Months
Patient registry
Yes

Groups and cohorts

  • S group

    underwent surgical treatment.

    Diagnostic Test: Since the data were collected retrospectively, there were no interventions

  • NS group

    underwent non-surgical treatment with RT and/or chemoradiotherapy.

    Diagnostic Test: Since the data were collected retrospectively, there were no interventions

Interventions

  • Diagnostic testSince the data were collected retrospectively, there were no interventions

    Since the data were collected retrospectively, there were no interventions

06

What researchers measure

Primary outcomes

  1. Selection of treatment modalities for elderly patients with oesophageal cancer

    Surgical data were retrospectively collected

    Time frame: 2009.01.01-2017.12.30

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Ozawa S, Ito E, Kazuno A, Chino O, Nakui M, Yamamoto S, Shimada H, Makuuchi H. Thoracoscopic esophagectomy while in a prone position for esophageal cancer: a preceding anterior approach method. Surg Endosc. 2013 Jan;27(1):40-7. doi: 10.1007/s00464-012-2404-3. Epub 2012 Jun 30. PubMed 22752274 ↗
  • Stokes A, Collins JM, Grant BF, Scamuffa RF, Hsiao CW, Johnston SS, Ammann EM, Manson JE, Preston SH. Obesity Progression Between Young Adulthood and Midlife and Incident Diabetes: A Retrospective Cohort Study of U.S. Adults. Diabetes Care. 2018 May;41(5):1025-1031. doi: 10.2337/dc17-2336. Epub 2018 Mar 5. PubMed 29506982 ↗
  • Reeves GK, Pirie K, Beral V, Green J, Spencer E, Bull D; Million Women Study Collaboration. Cancer incidence and mortality in relation to body mass index in the Million Women Study: cohort study. BMJ. 2007 Dec 1;335(7630):1134. doi: 10.1136/bmj.39367.495995.AE. Epub 2007 Nov 6. PubMed 17986716 ↗
  • Low DE, Alderson D, Cecconello I, Chang AC, Darling GE, D'Journo XB, Griffin SM, Holscher AH, Hofstetter WL, Jobe BA, Kitagawa Y, Kucharczuk JC, Law SY, Lerut TE, Maynard N, Pera M, Peters JH, Pramesh CS, Reynolds JV, Smithers BM, van Lanschot JJ. International Consensus on Standardization of Data Collection for Complications Associated With Esophagectomy: Esophagectomy Complications Consensus Group (ECCG). Ann Surg. 2015 Aug;262(2):286-94. doi: 10.1097/SLA.0000000000001098. PubMed 25607756 ↗
  • Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992 May;111(5):518-26. PubMed 1598671 ↗
  • Cunningham SC, Kavic SM. What is a surgical complication? World J Surg. 2009 May;33(5):1099-100; author reply 1101. doi: 10.1007/s00268-008-9881-5. No abstract available. PubMed 19130118 ↗
  • Ji Y, Du X, Zhu W, Yang Y, Ma J, Zhang L, Li J, Tao H, Xia J, Yang H, Huang J, Bao Y, Du D, Liu D, Wang X, Li C, Yang X, Zeng M, Liu Z, Zheng W, Pu J, Chen J, Hu W, Li P, Wang J, Xu Y, Zheng X, Chen J, Wang W, Tao G, Cai J, Zhao J, Zhu J, Jiang M, Yan Y, Xu G, Bu S, Song B, Xie K, Huang S, Zheng Y, Sheng L, Lai X, Chen Y, Cheng L, Hu X, Ji W, Fang M, Kong Y, Yu X, Li H, Li R, Shi L, Shen W, Zhu C, Lv J, Huang R, He H, Chen M. Efficacy of Concurrent Chemoradiotherapy With S-1 vs Radiotherapy Alone for Older Patients With Esophageal Cancer: A Multicenter Randomized Phase 3 Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1459-1466. doi: 10.1001/jamaoncol.2021.2705. PubMed 34351356 ↗
  • Mohata S, Kumar HS, Sharma N, Jhakhar SL, Beniwal S, Harsh KK. Acute treatment-related toxicity in elderly patients with good performance status compared to young patients in locally advanced esophageal carcinoma treated by definitive chemoradiation: A retrospective comparative study. J Cancer Res Ther. 2020 Jan-Mar;16(1):116-119. doi: 10.4103/jcrt.JCRT_878_18. PubMed 32362620 ↗
  • Zhao Q, Hu G, Xiao W, Chen Y, Shen M, Tang Q, Ning X. Comparison of definitive chemoradiotherapy and radiotherapy alone in patients older than 75 years with locally advanced esophageal carcinoma: A retrospective cohort study. Medicine (Baltimore). 2017 Sep;96(35):e7920. doi: 10.1097/MD.0000000000007920. PubMed 28858114 ↗
  • Wang BY, Hung WH, Wu SC, Chen HC, Huang CL, Lin CH, Chen HS. Comparison Between Esophagectomy and Definitive Chemoradiotherapy in Patients With Esophageal Cancer. Ann Thorac Surg. 2019 Apr;107(4):1060-1067. doi: 10.1016/j.athoracsur.2018.11.036. Epub 2018 Dec 17. PubMed 30571951 ↗
  • Nomura M, Oze I, Kodaira T, Abe T, Komori A, Narita Y, Masuishi T, Taniguchi H, Kadowaki S, Ura T, Andoh M, Tachibana H, Uemura N, Tajika M, Niwa Y, Muto M, Muro K. Comparison between surgery and definitive chemoradiotherapy for patients with resectable esophageal squamous cell carcinoma: a propensity score analysis. Int J Clin Oncol. 2016 Oct;21(5):890-898. doi: 10.1007/s10147-016-0963-3. Epub 2016 Mar 15. PubMed 26980212 ↗
  • Kranzfelder M, Schuster T, Geinitz H, Friess H, Buchler P. Meta-analysis of neoadjuvant treatment modalities and definitive non-surgical therapy for oesophageal squamous cell cancer. Br J Surg. 2011 Jun;98(6):768-83. doi: 10.1002/bjs.7455. Epub 2011 Apr 4. PubMed 21462364 ↗
  • Bedenne L, Michel P, Bouche O, Milan C, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Herr JP, Paillot B, Arveux P, Bonnetain F, Binquet C. Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus: FFCD 9102. J Clin Oncol. 2007 Apr 1;25(10):1160-8. doi: 10.1200/JCO.2005.04.7118. PubMed 17401004 ↗
  • Yuan P, Xiang J, Borg M, Chen T, Lin X, Peng X, Zheng K. Analysis of lifetime death probability for major causes of death among residents in China. BMC Public Health. 2020 Jul 11;20(1):1090. doi: 10.1186/s12889-020-09201-7. PubMed 32652968 ↗
  • Vlacich G, Samson PP, Perkins SM, Roach MC, Parikh PJ, Bradley JD, Lockhart AC, Puri V, Meyers BF, Kozower B, Robinson CG. Treatment utilization and outcomes in elderly patients with locally advanced esophageal carcinoma: a review of the National Cancer Database. Cancer Med. 2017 Dec;6(12):2886-2896. doi: 10.1002/cam4.1250. Epub 2017 Nov 15. PubMed 29139215 ↗
  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PubMed 33538338 ↗
  • Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Lordick F, D'Journo XB, Cerfolio RJ, Korst RJ, Novoa NM, Swanson SJ, Brunelli A, Ismail M, Fernando HC, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J; AME Thoracic Surgery Collaborative Group. Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial. J Clin Oncol. 2018 Sep 20;36(27):2796-2803. doi: 10.1200/JCO.2018.79.1483. Epub 2018 Aug 8. PubMed 30089078 ↗
  • Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lievre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125. Erratum In: N Engl J Med. 2023 Feb 16;388(7):672. doi: 10.1056/NEJMx220014. PubMed 33789008 ↗
  • Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5. PubMed 26254683 ↗
  • Li C, Zhao S, Zheng Y, Han Y, Chen X, Cheng Z, Wu Y, Feng X, Qi W, Chen K, Xiang J, Li J, Lerut T, Li H. Preoperative pembrolizumab combined with chemoradiotherapy for oesophageal squamous cell carcinoma (PALACE-1). Eur J Cancer. 2021 Feb;144:232-241. doi: 10.1016/j.ejca.2020.11.039. Epub 2020 Dec 26. PubMed 33373868 ↗
  • Rentz J, Bull D, Harpole D, Bailey S, Neumayer L, Pappas T, Krasnicka B, Henderson W, Daley J, Khuri S. Transthoracic versus transhiatal esophagectomy: a prospective study of 945 patients. J Thorac Cardiovasc Surg. 2003 May;125(5):1114-20. doi: 10.1067/mtc.2003.315. PubMed 12771885 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05604950
Lead sponsor
Yongtao Han
Responsible party
Yongtao Han (Clinical Professor, Sichuan Cancer Hospital and Research Institute) — Sponsor-investigator
First posted
Nov 3, 2022
Start date
Jan 1, 2009
Primary completion
Dec 30, 2019
Completion
Oct 1, 2022
Last update
Nov 3, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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