Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients
Recruiting
Phase 3
Interventional Study
Esophageal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Chinese Academy of Medical Sciences · Other
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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 chemoradiati…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 16-70 years;
* KPS\>7…
Contacts