Spots Global Cancer Trial Database for A Phase II Trial to Compare Efficacy and Safety of CRT VS Neo-CRT in Patients Who Achieved CCR for Esophageal Cancer
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Trial Identification
Brief Title: A Phase II Trial to Compare Efficacy and Safety of CRT VS Neo-CRT in Patients Who Achieved CCR for Esophageal Cancer
Official Title: A Phase II Trial to Compare Efficacy and Safety of Definitive Radiochemotherapy VS Neoadjuvant Radiochemotherapy Plus Surgery in Patients Who Achieved Clinical Complete Response After Neoadjuvant Treatment for Stage II-III Esophageal Cancer
Study ID: NCT02959385
Study Description
Brief Summary: Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced oesophageal 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 II 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 stage II-III esophageal Cancer.
Detailed Description: 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. 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 clinical complete 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital, Tianjin, Tianjin, China
Contact Details
Name: Qingsong Pang, Doctor
Affiliation: Tianjin Medical University Cancer Institute and Hospital
Role: STUDY_CHAIR
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