Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC
Esophageal Squamous Cell Carcinoma, Chemotherapy Effect, Side Effect of Drug
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About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria: Age 18-70 years old, not limited to male or female; at least able to take liquid diet; Esophageal squamous cell carcinoma proved by histopathology; Esophageal squamous cell carcinoma that is inoperable or refuses surgery, According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage; ECOG 0-1; life expectancy > 6 months; No chemotherapy was used before selection; No history of radiotherapy; No surgical treatment; No serious allergic history; Hemoglobin 100 g/L, WBC3.5109/L, neutrophils 1.5109, platelets 100109/L; CR1.5 upper limit of normal, TB2.5 upper limit of normal, AST and ALT2.5 upper normal limit, AKP2.5 upper normal limit ; Be able to understand the research and have signed the informed consent; Exclusion Criteria: History of malignant tumors in other parts; Duplicate carcinoma of the esophagus; Pregnant or lactating patients; Fertility but not using contraceptive measures; Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes; During the active period of infectious diseases; Participate in other clinical trials at present or within four weeks before enrollment; Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine); After esophageal stent placement; Cases with perforation tendency; Have a history of organ transplantation. Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases; Known or suspected allergic to chemotherapy drugs; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Sites / Locations
- The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Group A: radical chemoradiotherapy group;
Group B: radical chemoradiotherapy combined with consolidation chemotherapy group
Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.
Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.