NCT05460403

Brief Summary

This retrospective study is exploring the treatment effect and toxicity of adjuvant radiotherapy in patients diagnosed with esophageal squamous cell carcinoma after R0 resection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,591

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

July 12, 2022

Last Update Submit

July 13, 2022

Conditions

Esophageal Cancer

Keywords

esophageal cancerpostoperative radiotherapyadjuvant radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    From the date of surgery to the date of death or the most recent follow-up.

    up to 5 years

Secondary Outcomes (3)

  • Disease-free survival (DFS)

    up to 5 years

  • Local-regional recurrence-free survival (LRFS)

    up to 5 years

  • Distant metastasis (DM)

    up to 5 years

Other Outcomes (1)

  • Adverse events

    up to 5 years

Study Arms (2)

Surgery alone

patients without adjuvant radiotherapy after R0 resection.

Adjuvant Radiotherapy

patients treated with adjuvant radiotherapy after R0 resection.

Radiation: Adjuvant Radiotherapy

Interventions

Adjuvant RadiotherapyRADIATION

Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks within 12 weeks after surgery in the absence of disease progression or unacceptable toxicity.

Adjuvant Radiotherapy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with esophageal squamous cell carcinoma after R0 resection were enrolled from January 1993 and December 2012.

You may qualify if:

  • KPS≥70
  • Pathologically diagnosis of esophageal cancer
  • Complete resection (R0 resection)

You may not qualify if:

  • Diagnosed with other malignancy within 5 years before surgery
  • Encountered recurrence or port-site implantation receiving palliative-intended radiotherapy
  • Diagnosed with adenosquamous carcinoma or basal cell-like carcinoma
  • Treated with PORT with uncertain radiation dose
  • Treated with PORT with radiation dose \> 60Gy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Science

Beijing, Chaoyang, 100020, China

RECRUITING

Related Publications (8)

  • Rice TW, Chen LQ, Hofstetter WL, Smithers BM, Rusch VW, Wijnhoven BP, Chen KL, Davies AR, D'Journo XB, Kesler KA, Luketich JD, Ferguson MK, Rasanen JV, van Hillegersberg R, Fang W, Durand L, Cecconello I, Allum WH, Cerfolio RJ, Pera M, Griffin SM, Burger R, Liu JF, Allen MS, Law S, Watson TJ, Darling GE, Scott WJ, Duranceau A, Denlinger CE, Schipper PH, Lerut TE, Orringer MB, Ishwaran H, Apperson-Hansen C, DiPaola LM, Semple ME, Blackstone EH. Worldwide Esophageal Cancer Collaboration: pathologic staging data. Dis Esophagus. 2016 Oct;29(7):724-733. doi: 10.1111/dote.12520.

    PMID: 27731547BACKGROUND

  • Rice TW, Ishwaran H, Hofstetter WL, Kelsen DP, Apperson-Hansen C, Blackstone EH; Worldwide Esophageal Cancer Collaboration Investigators. Recommendations for pathologic staging (pTNM) of cancer of the esophagus and esophagogastric junction for the 8th edition AJCC/UICC staging manuals. Dis Esophagus. 2016 Nov;29(8):897-905. doi: 10.1111/dote.12533.

    PMID: 27905172BACKGROUND

  • Hsu PK, Chen HS, Huang CS, Liu CC, Hsieh CC, Hsu HS, Wu YC, Wu SC. Patterns of recurrence after oesophagectomy and postoperative chemoradiotherapy versus surgery alone for oesophageal squamous cell carcinoma. Br J Surg. 2017 Jan;104(1):90-97. doi: 10.1002/bjs.10334. Epub 2016 Nov 15.

    PMID: 27859017BACKGROUND

  • Parry K, Visser E, van Rossum PS, Mohammad NH, Ruurda JP, van Hillegersberg R. Prognosis and Treatment After Diagnosis of Recurrent Esophageal Carcinoma Following Esophagectomy with Curative Intent. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S1292-300. doi: 10.1245/s10434-015-4840-5. Epub 2015 Sep 3.

    PMID: 26334295BACKGROUND

  • Blom RL, Lagarde SM, van Oudenaarde K, Klinkenbijl JH, Hulshof MC, van Laarhoven HW, Bergman JJ, Busch OR, van Berge Henegouwen MI. Survival after recurrent esophageal carcinoma has not improved over the past 18 years. Ann Surg Oncol. 2013 Aug;20(8):2693-8. doi: 10.1245/s10434-013-2936-3. Epub 2013 Apr 3.

    PMID: 23549882BACKGROUND

  • Xiao ZF, Yang ZY, Liang J, Miao YJ, Wang M, Yin WB, Gu XZ, Zhang DC, Zhang RG, Wang LJ. Value of radiotherapy after radical surgery for esophageal carcinoma: a report of 495 patients. Ann Thorac Surg. 2003 Feb;75(2):331-6. doi: 10.1016/s0003-4975(02)04401-6.

    PMID: 12607634BACKGROUND

  • Deng W, Yang J, Ni W, Li C, Chang X, Han W, Zhou Z, Chen D, Feng Q, Liang J, Lv J, Wang X, Wang X, Deng L, Wang W, Bi N, Zhang T, Li Y, Gao S, Xue Q, Mao Y, Sun K, Liu X, Fang D, Wang D, Li J, Zhao J, Shao K, Li Z, Chen X, Han L, Wang L, He J, Xiao Z. Postoperative Radiotherapy in Pathological T2-3N0M0 Thoracic Esophageal Squamous Cell Carcinoma: Interim Report of a Prospective, Phase III, Randomized Controlled Study. Oncologist. 2020 Apr;25(4):e701-e708. doi: 10.1634/theoncologist.2019-0276. Epub 2020 Feb 21.

    PMID: 32083766BACKGROUND

  • Ni W, Yu S, Xiao Z, Zhou Z, Chen D, Feng Q, Liang J, Lv J, Gao S, Mao Y, Xue Q, Sun K, Liu X, Fang D, Li J, Wang D, Zhao J, Gao Y. Postoperative Adjuvant Therapy Versus Surgery Alone for Stage IIB-III Esophageal Squamous Cell Carcinoma: A Phase III Randomized Controlled Trial. Oncologist. 2021 Dec;26(12):e2151-e2160. doi: 10.1002/onco.13914. Epub 2021 Aug 19.

    PMID: 34309117BACKGROUND

Related Links

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsRadiotherapy

Study Officials

  • Zefen Xiao, MD

    Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zefen Xiao, MD

CONTACT

8610-87787643xiaozefen@sina.com

Weiming Han, MD

CONTACT

86-13661373730weiming_han@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 15, 2022

Study Start

April 23, 2022

Primary Completion

July 2, 2023

Study Completion

August 31, 2023

Last Updated

July 15, 2022

Record last verified: 2022-07

Locations

CN(1)