Last updated: June 12, 2023
Sponsor: Peking University Cancer Hospital & Institute
Overall Status: Completed
Phase
N/A
Condition
Digestive System Neoplasms
Esophageal Cancer
Esophageal Disorders
Treatment
Standard-dose
High-dose
Clinical Study ID
NCT02850991
ESR-15-11224
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed informed consent form
- Age: 18-75 years
- Histological or cytologic diagnosis of esophageal squamous cell carcinoma within onemonth. Clinical stage T1-4 N0-1 M0-1a (AJCC 6th edition). Supraclavicular lymphaticmetastasis or abdominal lymph node metastasis for mid-thoracic also can be included
- Karnofsky performance status scores: ≥70
- Without any prior anticancer therapy
- BMI≥18kg/m2 or weight loss ≤5% within 3 months
- Adequate marrow function (within 7 days): White blood cell ≥ 3×109/L,Neutrophils (ANC) ≥1.5×109/L, Platelet count ≥100×109/L, Hemoglobin ≥90g/L. Normal hepatic and renalfunction (within 14 days): Total bilirubin <1.5 x upper limit of normal (ULN), Alanineaminopeptidase and Aspartase aminotransferase ≤ 2.5 x ULN, creatinine ≤ 1.5xULN
- Normal cardiac and pulmonary function: Forced expiratory volume at one second (FEV1) ≥1.0 L or FEV1/FVC ≥ 50% pre FEV1; No myocardial infarction within 1 year; nosymptomatic heart disease, including myocardial ischemia, congestive heart failure oruncontrolled arrhythmias, roughly normal electrocardiogram; LVEF ≥ 50%,or can receivechemoradiotherapy assessed by cardiologists
Exclusion
Exclusion Criteria:
- Other or mixed pathological type
- The second primary tumor of esophageal cancer located outside the radiation area
- Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula
- Mid-thoracic esophageal cancer with supraclavicular lymphatic metastasis and abdominallymph node metastasis; other metastasis
- Within 2cm of the gastroesophageal junction
- Prior chemotherapy, prior thoracic radiation, surgical resection or target therapy ofthe primary tumor
- Significant medical or psychiatric illnesses that in the physician's judgment (uncontrolled coronary heart disease, cardiomyopathy and/or heart failure requiringhospitalization. Uncontrolled hypertension or history of myocardial infarction withinone year. Uncontrolled diabetes mellitus. Acute bacterial or fungal infectionrequiring intravenous antibiotics. Acute exacerbation of chronic obstructive pulmonarydisease (COPD) or other pulmonary disease requiring hospitalization influencing tumortreatment
- Refused to sign informed consent form
- Concurrent pregnancy or lactation
- History of a second malignancy other than nonmelanoma skin cancer, and cervical cancerin situ.
Study Design
Total Participants: 167
Treatment Group(s): 2
Primary Treatment: Standard-dose
Phase:
Study Start date:
April 01, 2016
Estimated Completion Date:
April 30, 2022
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaSite Not Available

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