Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer

  • STATUS
    Recruiting
  • End date
    Apr 30, 2022
  • participants needed
    46
  • sponsor
    Ruijin Hospital
Updated on 22 January 2021
esophagectomy
cancer
carcinoma
squamous cell carcinoma
metastasis
chemoradiotherapy
capecitabine
esophageal cancer
esophagus cancer
squamous cell carcinoma of esophagus
chemo-radiotherapy
kidney function test

Summary

Esophageal cancer (EC) ranks the seventh most diagnosed malignant tumor (572,000 new cases) and the sixth cancer-related mortality (509,000 deaths) worldwide in 2018. The incidence of EC is strikingly varying among the regions and sexes. Approximately 70% of EC cases occur in men, and there is a 2-fold to 3-fold difference in incidence and mortality rates between regions worldwide. According to the latest reported in 2017, esophageal cancer ranks the sixth most common cancer and the fourth leading cause of cancer-mortality in China. Currently, esophagectomy is considered as the standard treatment for resectable EC patients. However, the prognosis of stage IIA-III esophageal cancer after esophagectomy remains poor, and local regional lymph node recurrence is the major patterns of recurrence, and mediastinal lymph node recurrence is one of the most common sites. Previous retrospective study has found that salvage chemoradiotherapy is a effective treatment option for these patients. However, the optimal dose remains unknown. In addition, no prospective trials have been conducted to investigate the efficacy and toxicities of salvage chemo-radiotherapy by using simultaneous integrated boost for the treatment of mediastinal lymph node recurrence after radical surgery of esophageal Cancer

Details
Condition Esophageal Diseases, Esophageal Cancer, head and neck cancer, Esophageal Carcinoma, Salvage Radiotherapy, Esophageal Disorders, Dose-escalation, Mediastinal Lymph Node Recurrence, Dose-escalation, Dose Escalation, esophagus cancer, oesophageal cancer, cancer of the esophagus, oesophageal carcinoma
Treatment treatment group(phase I), treatment group (phase II)
Clinical Study IdentifierNCT03990532
SponsorRuijin Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histo-pathologically proven diagnosis of esophageal squamous cell carcinoma
Age 18 and 80 ECOG performance status 0-1. Clinical diagnosis of 5 mediastinal
lymph nodes recurrence after esophagectomy
Patients without distant metastasis and life expectancy 3 months. adequate
liver and renal function and adequate bone marrow reservation. Written, signed
informed consent

Exclusion Criteria

Prior radiotherapy to recurrence site of esophageal cancer. Other co-existing
malignancies or malignancies diagnosed within the last 5 years
Pregnant women. Women who are breastfeeding a baby. Patients with uncontrolled
serious medical or mental illnesses
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