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

July 13, 2022 updated by: Zefen Xiao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
This retrospective study is exploring the treatment effect and toxicity of adjuvant radiotherapy in patients diagnosed with esophageal squamous cell carcinoma after R0 resection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

3591

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chaoyang
      • Beijing, Chaoyang, China, 100020
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Science
        • Contact:
        • Contact:

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery alone
patients without adjuvant radiotherapy after R0 resection.
Adjuvant Radiotherapy
patients treated with adjuvant radiotherapy after R0 resection.
Radiation: Adjuvant Radiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to 5 years
From the date of surgery to the date of death or the most recent follow-up.
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: up to 5 years
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.
up to 5 years
Local-regional recurrence-free survival (LRFS)
Time Frame: up to 5 years
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.
up to 5 years
Distant metastasis (DM)
Time Frame: up to 5 years
From the date of surgery to the date of metastasis in distant lymph nodes, distant organs or the most recent follow-up.
up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: up to 5 years
From the date of surgery to the date of death or last follow-up
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Fujian Cancer Hospital

Investigators

  • Principal Investigator: Zefen Xiao, MD, Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Science

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

Helpful Links

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)

April 23, 2022

Primary Completion (Anticipated)

July 2, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 15, 2022

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K201427

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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