SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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This study was designed to predict the toxicity and efficacy of Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic I-IVA Esophageal Squamous Cell Carcinoma.

Official Title
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Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic Esophageal Squamous Cell Carcinoma: a Phase II Study of Single Institution

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Radiation: Simultaneous integrated boost intensity-modulated chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytologic diagnosis of esophageal squamous carcinoma; Aged 18-75 years; KPS ≥ 70; Upper thoracic esophageal squamous carcinoma: the upper margin of the lesion is located between the entrance of esophagus and the inferior edge of the azygos vein; Stage I-IVA(AJCC 6th,2009); Not able to be surgically resection or rejected; Not have received any prior anticancer therapy; No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥4x109/L, Neutrophils (ANC )≥1.5x10^9/L, platelet count ≥100x 10^9/L, serum creatinine<1.5 mg/dL,urea nitrogen <8 mmol/L; No history of malignancy; No perforation of esophagus, no deep ulcer of esophagus; Joined the study voluntarily and signed informed consent form. Exclusion Criteria: Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives; Patient who has metastasis such as lung, liver metastasis; Other malignant tumors; Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; Uncontrollable heart disease, diabetes and hypertension, pulmonary fibrosis, and chest confirmed active pulmonary inflammation require antibiotic treatment, as well as superior vena cava compression syndrome; After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy; Combination of pure red cell anemia or gamma globulin; Allergic to any medication component studied.

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
Intervention Model: Single Group Assignment
Interventional Model Description: Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIB<br>Simultaneous integrated boost intensity-modulated chemoradiotherapy | Radiation: Simultaneous integrated boost intensity-modulated chemoradiotherapy<br>* Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity Effect | Toxicity effect defined as over CTCAE 4 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy. | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Time of disease progression or unrecorded time of death due to any cause from the day of admission to the first imaging confirmation | One month | 
| OS | Time from admission to death | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, Chemoradiotherapy, Simultaneous Integrated Boost Intensity