- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05604950
Surgery Versus Non-surgical Treatment for Esophageal Squamous Cell Carcinoma in Patients Older Than 70 Years
October 31, 2022 updated by: Yongtao Han
Sichuan Cancer Hospital & Institute
To determine whether older patients who underwent esophagectomy had better outcome survival than those who were non-surgically treated.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
68 years to 98 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Pathology confirmed ESCC,
- Patients with esophagectomy or radiotherapy (RT)/chemotherapy (CT),
- Age ≥ 70.
Exclusion Criteria:
- Having other malignant tumours,
- Missing of required data.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
S group
underwent surgical treatment.
|
Since the data were collected retrospectively, there were no interventions
|
NS group
underwent non-surgical treatment with RT and/or chemoradiotherapy.
|
Since the data were collected retrospectively, there were no interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Selection of treatment modalities for elderly patients with oesophageal cancer
Time Frame: 2009.01.01-2017.12.30
|
Surgical data were retrospectively collected
|
2009.01.01-2017.12.30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2009
Primary Completion (Actual)
December 30, 2019
Study Completion (Actual)
October 1, 2022
Study Registration Dates
First Submitted
October 23, 2022
First Submitted That Met QC Criteria
October 31, 2022
First Posted (Actual)
November 3, 2022
Study Record Updates
Last Update Posted (Actual)
November 3, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
Other Study ID Numbers
- SCCH-TS2022
- No. 2020YFH0169 (Other Grant/Funding Number: the International Cooperation Projects of Science and Technology of Sichuan Province)
- No. 320.6750.2020-15-3 (Other Grant/Funding Number: The Wu Jieping Clinical Research Projects)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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