Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma.

Official Title
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A Phase III Study of Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Joined the study voluntarily and signed informed consent form; Age 18-75 years; both genders Esophageal squamous cell carcinoma confirmed by pathology. No radiotherapy, chemotherapy or other treatments prior to enrollment Locally advanced esophageal squamous cell carcinoma (T1N1-3M0, T2-4NxM0, TxNxM1 (supraclavicular lymph node metastasis only) (AJCC 8th) Use of an effective contraceptive for adults to prevent pregnancy. No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function. No immunodeficiency. WBC ≥ 3.5*109/L, Hemoglobin ≥ 9 g/dL, Neutrophils ≥ 1·5*109/L, Platelet count ≥ 100*109/L, ALAT and ASAT < 2·5 * ULN, TBIL < 1·5 * ULN, and Creatinine < 1·5 *ULN. ECOG 0-2. Life expectancy of more than 3 months. Agreement of PET/CT accessment at 25-28 radiotherapy fraction. Exclusion Criteria: Total radiotherapy dose cannot reach 61.2Gy/34Fx in the condition of the nomal tissue dose complying to the standard criteria. Esophageal perforation, or hematemesis. History of radiotherapy or chemotherapy for esophageal cancer. History of surgery within 28 days before Day 1. History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years). Participation in other interventional clinical trials within 30 days. Pregnant or breast-feeding women or fertile patients who refused to use contraceptives. Drug addiction, alcoholism or AIDS. Uncontrolled seizures or psychiatric disorders. Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.

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 |
| --- | --- |
| Active Comparator: 50.4Gy<br>Total radiotherapy dose of 50.4Gy. | Radiation: Radiotherapy<br>* Different total radiotherapy dose between two arms.<br>|
| Experimental: 61.2Gy<br>Total radiotherapy dose of 61.2Gy. | Radiation: Radiotherapy<br>* Different total radiotherapy dose between two arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival in PET/CT non-responders | The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study. | 2 years | 
| Overall survival in ITT population | The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate | The time between the start of the study treatment (Day 1) and local reccurence (included the primary tumor and regional lymph node failure) | 2 years | 
| Progression-free survival | (defined as the time between Day 1 and the first event of local failure, metastatic recurrence, progression or death) | 2 years | 
| Overall survival in PET/CT responders | Overall survival in patients who have SUV ≤ 4 in PET/CT analysis in 25-28 radiotherapy fractions. | 2 years | 
| Questionnaire EORTC-QLQ-C30 | A quality of life score is obtained according to the answers to the questionnaires. | 2 years | 
| Questionnaire EORTC-QLQ-OES18 | A quality of life score is obtained according to the answers to the questionnaires. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemoradiotherapy, esophageal cancer, PET/CT