Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT00815308
Eligibility Criteria:
Inclusion Criteria:
* Inpatients or outpatients, ≥ 18 years of age
* Histologically confirmed primary (non-recurrent) ESCC fulfilling one of the following criteria (AJCC Staging System)
* cervical esophageal carcinoma, stage Ⅱ-Ⅲ
* upper thoracic esophageal carcinoma, stage Ⅱ-Ⅲ, or mid-thoracic esophageal carcinoma, stage Ⅱ-Ⅲ,which is medically unfit for surgery, surgery been refused and patient medically able to tolerate chemo-radiation.
* Evidence of unidimensional measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST).
* ECOG Performance status of 0-1
* Effective contraception for both male and female patients if the risk of conception exists
* Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl
* Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min
* Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT \& ALST ≤ 1.5 x ULN
* Tumor tissue available for KRAS biomarker test
* Signed written informed consent prior to study entry
Exclusion Criteria:
* Previous chest radiotherapy, systemic chemotherapy, and major esophageal surgery
* Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol
* Multiple primary carcinomas of the esophagus
* Pregnancy (confirmed by serum or urine β-HCG) or lactation period;
* Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease
* Unable to comprehend the study requirements or who are not likely to comply with the study parameters;
* Distant metastasis
* Second malignancy, except for curable non-melanoma skin cancer, cervical cancer in situ, or malignant disease, free for ≥ 5 years
* Known grade 3 or 4 allergic reaction to any of the study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00815308
Study Brief:
Protocol Section:
NCT00815308