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:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT00416858
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed epidermoid or glandular cancer of the esophagus meeting the following criteria:
* Tumor volume with or without mediastinal adenopathy, celiac, or subclavicular involvement
* T3, N0-N1 disease
* Tumor extends into fifth stratum by endosonographic scan
* Resectable disease (palliative or curative)
* No cervical tumor
* No T1, T2, or T4 tumors
* No tracheo-esophageal fistula or tracheal invasion
* No gastric cardia cancer by gastroscopy
* No visceral (e.g., lung, bone, brain, liver), ganglion, or clavicular metastases
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Creatinine normal
* WBC ≥ 3,000/mm\^3
* Neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Transaminases ≥ 60%
* Bilirubin ≤ 2.0 mg/dL
* No cirrhosis
* DLCO ≥ 1.5 L with or without hypoxemia at rest
* No progressive coronary insufficiency
* Weight loss ≤ 15%
* No other malignancy in the past 2 years
* Must be able to maintain sufficient enteral nutrition (2,000 calories/day)
* Laser photodestruction, dilation, or gastric balloon allowed
* No contraindication to radiotherapy
* No recurring left paralysis
PRIOR CONCURRENT THERAPY:
* No concurrent nephrotoxic or myelotoxic drugs
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00416858
Study Brief:
Protocol Section:
NCT00416858