NCT03731442RecruitingPhase 3
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial
Source: ClinicalTrials.gov · Last updated 12 Dec 2018 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 31 Oct 2018
- Start date
- 1 Nov 2018
- Primary completion date
- 31 Oct 2022
- Lead sponsor
- Chinese Academy of Medical Sciences
- NCT number
- NCT03731442
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 1 Nov 2018 to the primary completion date, 31 Oct 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of drug allergy;
- Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.
Age
- Age\>70 or \<16 years;
Other
- Pregnancy or lactation;
- Declining informed consent;
- Insufficient liver or kidney functions, or abnormal CBC test;
Who the study is looking for
- 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\>70;
- No history of drug allergy;
- Sufficient liver and kidney functions;
- White blood cell count \> 4.0\*10\^9/L.
Age in the registry: 16 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 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) Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.