Stage III Esophageal Cancer Clinical Trial
Official title:
A Phase Ⅲ Trial to Compare Efficacy and Safety of Definitive Chemoradiation VS Neoadjuvant Chemoradiation Plus Surgery in Patients Who Achieved Clinical Complete Response After Neoadjuvant Treatment for Locally Advanced Esophageal Cancer
Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced esophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond to chemoradiation. Herein, a single center prospective randomized phase Ⅲ multicenter clinical trial will be carried out to compare efficacy and safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection in patients who achieved clinical complete response (CCR) after neoadjuvant radiochemotherapy for resectable locally advanced esophageal cancer.
1. Compare progression-free survival (PFS) and overall survival (OS) of definitive
radiochemotherapy versus(VS) neoadjuvant radiochemotherapy plus radical resection for
esophageal cancer patients who achieved clinical complete response after neoadjuvant
treatment;
2. Compare the toxic and side effects of definitive radiochemotherapy versus neoadjuvant
radiochemotherapy plus radical resection for esophageal cancer patients who achieved
clinical complete remission after neoadjuvant treatment;
3. Compare the relationship and consistency between pathological complete response of
endoscopic biopsy specimens after neoadjuvant treatment and pathological complete
response of surgical specimens in neoadjuvant radiochemotherapy plus radical resection
group;
4. Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus
radical resection on quality of life of patients.
5. Clinical Complete Response After Neoadjuvant Treatment: Endoscope biopsy pathologic
diagnosis indicate pathologic complete response after Neoadjuvant treatment; upper
gastrointestinal/chest CT and symptom assessment indicate major response after
Neoadjuvant treatment (Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation
Radiation Therapy(IMRT), 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2),
1st/8th/15th/22nd day
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