AzTrials
AzTrials

Esophageal CancerNCT05460403

Adjuvant Radiotherapy for Patients With Esophageal Squamous Cell Carcinoma After R0 Resection

An observational study of Esophageal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Adjuvant Radiotherapy
Type of treatment
Surgery or procedure
How many people
3,591 participants
Where
1 siteChina
Study dates
23 Apr 2022to 31 Aug 2023
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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Zefen Xiao, MD contact

8610-87787643

xiaozefen@sina.com

Weiming Han, MD contact

86-13661373730

weiming_han@163.com

China1 site, 1 recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Science

    Beijing, Chaoyang, 100020

    Zefen Xiao, MD, 8610-87787463, xiaozefen@sina.com

    Weiming Han, MD, 86-13661373730, weiming_han@163.com

    Recruiting

Other trials in China

About this study

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

Read the detailed description

Surgery is one of the most important curative approaches for esophageal cancer. In real-world clinical practice, over 50% of the patients receiving surgical resection as primary management. For patients treated with surgical resection without adjuvant therapy, the probability of local-regional recurrence ranged from 23.0% to 56.5%, accounting for 55.6%-84.5% of the disease recurrence. Once encountering disease recurrence, the subsequent prognosis could be dismal. The median survival time after postoperative disease recurrence ranged from 3 to 8 months. Postoperative radiotherapy (PORT) was one of the potential topical treatment approaches prolonging local-regional recurrence time or moreover, attaining superior disease-free survival (DFS) or overall survival (OS) in selected patients. It is essential to identify patients potentially benefit from PORT. Besides, there were few studies evaluating the impact of postoperative radiation dose to survival outcomes in patients receiving PORT. Whether the PORT-related local-regional recurrence free survival (LRFS) enhancement could convert to OS or DFS improvement is still vague. The current study aimed at evaluating the value of PORT in patients diagnosed with esophageal squamous cell carcinoma after R0 resection.

Being tested
Adjuvant Radiotherapy
Keywords
esophageal cancer, postoperative radiotherapy, adjuvant radiotherapy
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • 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.

Study groups in NCT05460403
Study groupRoleWhat they receive
Surgery alonepatients without adjuvant radiotherapy after R0 resection.
Adjuvant Radiotherapypatients treated with adjuvant radiotherapy after R0 resection.
Receives: Radiation: Adjuvant Radiotherapy

What is being measured

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

  1. Overall survival (OS)

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

    Measured: up to 5 years

Secondary outcomes (3)

  1. Disease-free survival (DFS)

    From the date of surgery to the date of any evidence of disease recurrence (recurrence in the tumor bed, anastomotic orifice, or in the regional lymph nodes, or metastasis in distant lymph nodes or distant organs), death or the most recent follow-up.

    Measured: up to 5 years

  2. Local-regional recurrence-free survival (LRFS)

    From the date of surgery to the date of recurrence in the tumor bed, anastomotic orifice, regional lymph nodes or the most recent follow-up.

    Measured: up to 5 years

  3. Distant metastasis (DM)

    From the date of surgery to the date of metastasis in distant lymph nodes, distant organs or the most recent follow-up.

    Measured: up to 5 years

Timeline

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

  1. First posted15 Jul 2022
  2. Study start23 Apr 2022
  3. Primary completion2 Jul 2023 (estimated)
  4. Study completion31 Aug 2023 (estimated)

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
Retrospective
Enrolment
3,591 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05460403
Sponsor's protocol ID
K201427
Status last verified
Jul 2022
First submitted
12 Jul 2022
Last updated
15 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27731547

  • 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.

    PubMed 27905172

  • 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.

    PubMed 27859017

  • 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.

    PubMed 26334295

  • 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.

    PubMed 23549882

  • 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.

    PubMed 12607634

  • 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.

    PubMed 32083766

  • 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.

    PubMed 34309117

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

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 5 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: status not confirmed, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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

Contact Zefen Xiao, MD (8610-87787643, xiaozefen@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: up to 5 years). 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 NCT05460403, which also lists 8 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 15 Jul 2022.

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