RecruitingPhase 3NCT03731442

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

Sponsor

Chinese Academy of Medical Sciences

Enrollment

300 participants

Start Date

Nov 1, 2018

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer

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.

Eligibility

Min Age: 16 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying combined chemotherapy and radiation therapy as a treatment option for people whose esophageal cancer has come back after surgery. **You may be eligible if...** - Your esophageal cancer has returned (recurred) in the area near the original surgery site - Cancer was found at the surgical edges (incomplete removal) after your operation - Your cancer came back after chemotherapy or radiation you received after surgery - You are aged 16–70 years - You have not had any treatment since the cancer came back - Your overall health is reasonably good (KPS greater than 70) - Your liver, kidney, and blood counts are within acceptable ranges **You may NOT be eligible if...** - You are older than 70 or younger than 16 - You are pregnant or breastfeeding - You have a known drug allergy to the treatment medications - You have serious kidney or liver problems - You have very low white blood cell counts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONInvolved field irradiation

Involved field irradiation; intensity-modulated radiation therapy

RADIATIONElective field irradiation

Elective field irradiation; intensity-modulated radiation therapy

DRUGPaclitaxel

Paclitaxel 135-150mg/m2, d1, every 3 weeks

DRUGPlatinum

for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;

DRUGPEG-rhG-CSF

PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy

Locations(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

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NCT03731442