Actively Recruiting

Phase 3
Age: 16Years - 70Years
All Genders
NCT03731442

Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients

Led by Chinese Academy of Medical Sciences · Updated on 2018-12-12

300

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

Sponsors

C

Chinese Academy of Medical Sciences

Lead Sponsor

T

The First Affiliated Hospital with Nanjing Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation. The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery.

CONDITIONS

Official Title

Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients

Who Can Participate

Age: 16Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Locoregional recurrence after radical surgery
  • Positive resection margin (R1/R2) after surgery
  • Out-of-field recurrence after adjuvant chemoradiation or radiotherapy
  • Recurrence after adjuvant chemotherapy
  • No prior therapy after recurrence
  • Age 16 to 70 years
  • Karnofsky performance status greater than 70
  • No history of drug allergy
  • Sufficient liver and kidney functions
  • White blood cell count greater than 4.0 x 10^9/L
Not Eligible

You will not qualify if you...

  • Age under 16 or over 70 years
  • Pregnancy or lactation
  • History of drug allergy
  • Declining informed consent
  • Insufficient liver or kidney functions, or abnormal complete blood count test
  • Severe cardiovascular diseases, infections, active ulcerations
  • Diabetes mellitus with unstable blood sugar
  • Mental disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

Z

Zefen Xiao, MD

CONTACT

L

Lei Deng, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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