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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT00109850
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (≥ 20 cm from the incisors\*) or the gastroesophageal junction (confined to ≤ 2 cm into the gastric cardia)
* Disease confined to the esophagus or peri-esophageal soft tissue
* T4, M0 disease
* Surgically unresectable disease by esophageal endoscopic ultrasonography OR medically unresectable disease
NOTE: \*Patients with primary disease \< 26 cm from the incisors must undergo bronchoscopy AND have negative cytology within the past 4 weeks
* Measurable or non-measurable disease by x-ray, CT scan and/or MRI, or physical examination within the past 4 weeks (for measurable disease) or within the past 6 weeks (for non-measurable disease)
* Tumor specimens available
* No recurrent disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
* White Blood Cell (WBC) count ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10.0 g/dL
Hepatic
* Albumin normal
* Bilirubin normal
* Alkaline phosphatase normal
* Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal
Renal
* Creatinine clearance \> 50 mL/min
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior severe reaction to monoclonal antibodies
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for esophageal cancer
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for esophageal cancer
* No concurrent intensity modulated radiotherapy
* No concurrent cobalt-60
Surgery
* No prior surgical resection or attempted surgical resection of esophageal cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00109850
Study Brief:
Protocol Section:
NCT00109850