Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma

Study Overview
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Brief Summary
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A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer.

Detailed Description
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A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone on the overall survival rate (OS) and disease-free survival (DFS) of patients with pN1-2 (pT1b-3N1-2M0) thoracic esophageal squamous cell carcinoma, and to observe the safety, side effects of adjuvant therapy and the impact on the quality of life of patients after operation.

Official Title
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Multicenter Prospective Randomized Controlled Study of Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone in the Treatment of pN1-2 (pT1b-3N1-2M0) Thoracic Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Combination Product: adjuvant treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants volunteer to participate the study and signed the informed consent. Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma. No antineoplastic treatments before operation. According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer; WHO PS score: 0-1; Age and gender: 18-75 years old, male and female unlimited; Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements. Exclusion Criteria: The surgical approach is left thoracic approach; Patients with severe postoperative complications who cannot receive adjuvant therapy; Received other anti-tumor treatment before enrollment; At the same time, patients with malignant tumors of other sites were excluded, except non-melanoma skin cancer, in-situ cervical cancer or cured early prostate cancer. Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment; Patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; Severe hepatic and renal insufficiency; Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response; Known or suspected allergy to chemotherapeutic drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Chemotherapy<br>Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles. | Combination Product: adjuvant treatment<br>* adjuvant treatments include chemotherapy or chemoradiotherapy<br>|
| Experimental: Chemoradiotherapy<br>5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles | Combination Product: adjuvant treatment<br>* adjuvant treatments include chemotherapy or chemoradiotherapy<br>|
| No Intervention: Surgery alone<br>Surgery alone, no adjuvant treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | overall survival rate of each arms | 3-year overall survival | 
| Overall Survival | overall survival rate of each arms | 5-year overall survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival | Disease free survival rate of each arms | 3-year disease free survival | 
| Disease Free Survival | Disease free survival rate of each arms | 5-year disease free survival | 
| Adverse Events | Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) | 1 year | 
| Scores of Quality of Life | Assess the quality of life based on EORTC QLQ-C30 and OES18 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal squamous cell carcinoma, adjuvant chemotherapy, adjuvant chemoradiotherapy, surgery