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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Chemoradiotherapy in Unresectable Esophageal Cancer

A Phase I/II Study of Chemoradiotherapy Using Albumin-Bound Paclitaxel and Cisplatin in Unresectable Esophageal Squamous Cell Carcinomas Based on Nutritional Risk Screening Score (NRS2002)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This phase I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.

Who May Be Eligible (Plain English)

Who May Qualify: - 18\~75 years - Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis) - Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences - ECOG PS score: 0\~1 - NRS2002 score \<3 - Estimated survival time ≥3 months - Normal organ and marrow function as defined below: Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit - willing to sign a consent form Who Should NOT Join This Trial: - With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc - Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer - Existing active infection such as active tuberculosis and hepatitis - History of myocardial infarction within the past 6 months or history of ventricular arrhythmia - Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness - History of allergic reactions attributed to paclitaxel, albumin or cisplatin - Participation in other clinical trials currently or within 4 weeks of selection - Pregnant or lactating females Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 18\~75 years * Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis) * Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences * ECOG PS score: 0\~1 * NRS2002 score \<3 * Estimated survival time ≥3 months * Normal organ and marrow function as defined below: Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit * Informed consent Exclusion Criteria: * With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc * Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer * Existing active infection such as active tuberculosis and hepatitis * History of myocardial infarction within the past 6 months or history of ventricular arrhythmia * Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness * History of allergic reactions attributed to paclitaxel, albumin or cisplatin * Participation in other clinical trials currently or within 4 weeks of selection * Pregnant or lactating females

Treatments Being Tested

RADIATION

Radiotherapy

59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks.

DRUG

Albumin-Bound Paclitaxel

100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.

DRUG

Cisplatin

25mg/m2 weekly,by intravenous infusion in 5-6 weeks.

Locations (5)

Department 4th of Radiation Oncology, Anyang Cancer Hospital
Anyang, Henan, China
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, China
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China