Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients

NCT03731442 · tracked via the Priya Life Science China tracker

Sponsor

Chinese Academy of Medical Sciences

Phase

Phase 3

Started

2018-11-01

Last updated

2018-12-12

Condition(s) studied

Esophageal Cancer

Investigational drug(s) / intervention(s)

Involved field irradiationElective field irradiationPaclitaxelPlatinumPEG-rhG-CSF

Involved field irradiation: Involved field irradiation; intensity-modulated radiation therapy

Elective field irradiation: Elective field irradiation; intensity-modulated radiation therapy

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

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;

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

Study 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

Sex

ALL

Min age

16 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

1-, 2-, 3-year overall survival — From treatment initiation to death from any cause or censor, assessed up to 36 months
Overall survival

Trial sites (1)

Facility	City	Region	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)	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03731442 on ClinicalTrials.gov ↗ ← All trials in China