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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-70
SponsorChinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

Age>70 or <16 years;

Pregnancy or lactation;

History of drug allergy;

Declining informed consent;

Trial design

Treatments tested in this trial

  • Involved field irradiation
  • Elective field irradiation
  • Paclitaxel
  • Platinum
  • PEG-rhG-CSF

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chinese Academy of Medical Sciences

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Anyang Tumor Hospital

Collaborator

Fujian Cancer Hospital

Collaborator

Peking University Cancer Hospital & Institute

Collaborator

Hebei Medical University Fourth Hospital

Collaborator