Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

Study Overview
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Brief Summary
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This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.

Detailed Description
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Test grouping: Group A: radical chemoradiotherapy group; Group B: radical chemoradiotherapy combined with consolidation chemotherapy group; Specific chemotherapy regimens: Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; 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. Primary efficacy endpoints: 3-year overall survival (OS), 5-year overall survival (OS) Secondary efficacy endpoints: 3-year progression-free survival (PFS), 5-year progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), toxic and side effects, and patient quality of life

Official Title
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A Prospective Randomized Controlled Clinical Study Comparing Curative Effect of Non-surgical Esophageal Squamous Cell Carcinoma With Radical Chemoradiotherapy and Radical Chemoradiotherapy Combined With Consolidation Chemotherapy

Conditions
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Esophageal Squamous Cell Carcinoma, Chemotherapy Effect, Side Effect of Drug

Intervention / Treatment
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* Combination Product: Consolidation chemotherapy (4 courses)
* Combination Product: Concurrent chemotherapy (2 courses)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group A: radical chemoradiotherapy group;<br>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. | Combination Product: Concurrent chemotherapy (2 courses)<br>* Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles;<br>|
| Experimental: Group B: radical chemoradiotherapy combined with consolidation chemotherapy group<br>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. | Combination Product: Consolidation chemotherapy (4 courses)<br>* 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;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-years overall survival (OS) | Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death. | up to 3 years | 
| 5-years overall survival (OS) | Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death. | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year progression-free survival (PFS) | The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death. | up to 3 years | 
| Objective response rate (ORR) Objective response rate (ORR) | Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission | through study completion, an average of 36 month | 
| 5-year progression-free survival (PFS) | The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death. | up to 5 years |