drugset / Trial / NCT03731442
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients
Phase 3
Recruiting
300 enrolled
Chinese Academy of Medical Sciences
Anyang Tumor Hospital · collabFujian Cancer Hospital · collabHebei Medical University Fourth Hospital · collabPeking University Cancer Hospital & Institute · collabThe First Affiliated Hospital with Nanjing Medical University · collabTianjin Medical University Cancer Institute and Hospital · collab
Non-randomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2018-11-01
- Primary completion
- 2022-10-31
- Completion
- 2027-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Lobaplatin | Small molecule | 30 mg/m2 | — |
| Background | Nedaplatin | Small molecule | 50 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 135 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 150 mg/m2 | — |
| Background | Pegfilgrastim | Protein / enzyme biologic | 3 mg | — |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | — |