Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.

Official Title
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A Prospective, Open-label, Phase I Study of Docetaxel and Nedaplatin Twice Weekly in Combination With Chest Radiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Nedaplatin
* Radiation: chest radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed esophageal squamous cell carcinoma Inoperable stage II-III (AJCC/UICC; seventh edition), confirmed by contrast- enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography. Eastern Cooperative Oncology Group (ECOG) performance status 1-2 Estimated life expectancy of at least 12 weeks Charlson comorbidity index≤4 Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1 Adequate renal function: creatinine grade 0 or 1 Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit Weight loss≤15% during 6 months prior to diagnosis Forced expiratory volume second≥1L Exclusion Criteria: Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy Contraindication for chemotherapy or radiotherapy Malignant pleural or pericardial effusion Women in pregnancy or lactation period Women who has the probability of pregnancy without contraception Weight loss≥15% during 3 months prior to diagnosis In other clinical trials within 30 days Addicted in drugs or alcohol, AIDS patients Uncontrollable seizure or psychotic patients without self-control ability Severe allergy or idiosyncrasy Not suitable for this study judged by researchers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel + Nedaplatin + Radiotherapy<br>Docetaxel and nedaplatin 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation. | Drug: Docetaxel<br>* 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation<br>Drug: Nedaplatin<br>* 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation<br>Radiation: chest radiation<br>* continuous chest radiation at 64 Gy/32f<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of dose limiting toxicity |  | From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks) | 
| Maximum tolerated dose |  | From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and severity of adverse events |  | From start of week 1 to 6 weeks after end of combination treatment (combination treatment = 6.5 weeks) | 
| Clinical response rate |  | 8 weeks after end of combination treatment | 
| Dynamic plasma concentration of docetaxel and nedaplatin |  | From start of week 1 to the end of combination treatment (6.5 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal squamous cell carcinoma, Chemoradiotherapy, Docetaxel, Nedaplatin, Twice weekly