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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Age\>70 or \<16 years; - Pregnancy or lactation; - History of drug allergy; - Declining willing to sign a consent form; - Insufficient liver or kidney functions, or abnormal CBC test; - Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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\>70; * No history of drug allergy; * Sufficient liver and kidney functions; * White blood cell count \> 4.0\*10\^9/L. Exclusion Criteria: * Age\>70 or \<16 years; * Pregnancy or lactation; * History of drug allergy; * Declining informed consent; * Insufficient liver or kidney functions, or abnormal CBC test; * Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.

Treatments Being Tested

RADIATION

Involved field irradiation

Involved field irradiation; intensity-modulated radiation therapy

RADIATION

Elective field irradiation

Elective field irradiation; intensity-modulated radiation therapy

DRUG

Paclitaxel

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

DRUG

Platinum

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

DRUG

PEG-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