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Esophageal Squamous Cell CarcinomaNCT05604950

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

An observational study of Esophageal Squamous Cell Carcinoma and Esophagectomy, run by Yongtao Han.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 70 to 100 yearsHealthy volunteers can take part
How many people
2 participants
Where
No sites listed yet
Study dates
1 Jan 2009to 1 Oct 2022
How long will I take part?
60 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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.

Who may be able to join

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

Who cannot join

  • Having other malignant tumours,
  • Missing of required data.

About this study

Official title: Sichuan Cancer Hospital & Institute

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

Being tested
Since the data were collected retrospectively, there were no interventions
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Since the data were collected retrospectively, there were no interventionsDiagnostic test

    Since the data were collected retrospectively, there were no interventions

Study groups in NCT05604950
Study groupRoleWhat they receive
S groupunderwent surgical treatment.
Receives: Diagnostic Test: Since the data were collected retrospectively, there were no interventions
NS groupunderwent non-surgical treatment with RT and/or chemoradiotherapy.
Receives: Diagnostic Test: Since the data were collected retrospectively, there were no interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Surgical data were retrospectively collected

    Measured: 2009.01.01-2017.12.30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2022
  2. Study start1 Jan 2009
  3. Primary completion30 Dec 2019
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
2 participants (actual)
Target duration
60 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05604950
Sponsor's protocol ID
SCCH-TS2022
Other IDs
No. 2020YFH0169, No. 320.6750.2020-15-3
Status last verified
Oct 2022
First submitted
23 Oct 2022
Last updated
3 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Squamous Cell Carcinoma and Esophagectomy, run by Yongtao Han.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Selection of treatment modalities for elderly patients with oesophageal cancer (time frame: 2009.01.01-2017.12.30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05604950, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.

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