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 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT00004257
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm from incisors) or gastroesophageal (GE) junction
* Stage I-III
* Bronchoscopy with biopsy and cytology required if primary esophageal cancer is less than 26 cm from incisors
* No disease outside esophagus and peri-esophageal soft tissue
* GE junction tumors must be confined to no greater than 2 cm into the gastric cardia
* Supraclavicular lymph nodes at station 1 must be less than 1.5 cm or nonpalpable by physical examination
* Nodes 1.5 cm or greater or palpable by physical examination must be confirmed to be nonmalignant by biopsy
* Subdiaphragmatic lymph nodes at stations 15-20 must be no greater than 1.5 cm
* No recurrent disease
* No known brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm3
* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin normal
* AST/ALT no greater than 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No grade 2 peripheral neuropathy
* No history of allergy to platinum compounds
* No history of allergy to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No other malignancy within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No colony-stimulating factor therapy during first study course
Chemotherapy:
* No prior chemotherapy for esophageal cancer
* At least 4 weeks since other prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for esophageal cancer
* At least 4 weeks since other prior radiotherapy
Surgery:
* No prior resection or attempted resection of esophageal cancer
Other:
* No other concurrent investigational drugs
* No other concurrent commercial agents or therapies for esophageal cancer
* No concurrent highly active antiretroviral agents (HAART) for HIV-positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004257
Study Brief:
Protocol Section:
NCT00004257