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:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT00915850
Eligibility Criteria:
Inclusion Criteria:
* locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan
* ECOG performance status 0-1
* 20 years and older
* Patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor
* Tissue from tumor must be available
* Patients must have measurable disease
* Patients may have received prior adjuvant chemotherapy; this must have been completed at least 1 month
* Life expectancy \> 3 months
* Laboratory values as follows
* 3000/mm3 \< WBC \< 12000/mm3
* 1500/mm3 \< granulocyte count
* 8.0 gm/dl \< hemoglobin
* Platelet count \> 100000/mm3
* Aspartate transaminase \< 150 IU/L
* Alanine transaminase \< 150 IU/L
* Creatinine \< 1.5 mg/dl
* Able and willing to give valid written informed consent
Exclusion Criteria:
* Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception)
* Active or uncontrolled infection
* Prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or immunotherapy within 1 week
* Clinically significant heart disease
* Patients with a history of myocardial infarction within the previous three months
* Patients with uncontrolled diabetes mellitus or hypertension
* Presence of clinically apparent central nervous system metastases
* Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study
* Decision of unsuitableness by principal investigator or physician-in-charge
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00915850
Study Brief:
Protocol Section:
NCT00915850