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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT00230451
Eligibility Criteria:
Patient Eligibility:
1. Histologically confirmed squamous cell carcinoma, adenocarcinoma, or mixed adeno/squamous of the the esophagus or gastroesophageal junction.
2. Disease limited to the esophagus and regional lymph nodes. However, celiac node enlargement will be acceptable for tumors of the distal esophagus, because they will be included in the radiation field.
3. Disease must be able to be encompassed in a single radiation field.
4. No medical contraindication to surgery.
5. All treatment is to be administered at the University of Michigan Medical Center
6. Karnofsky Performance Status \> 60%
7. Ages 18-75
8. Adequate renal function (BUN \<1.5 x N; creatinine \<1,5 mg/dl, or measured creatinine clearance\>60 ml/min.).
9. Adequate bone marrow reserve (WBC\>3500/ul; Platelets\>100,000/ul.).
10. Adequate hepatic function (Bilirubin\<1.5x N; AST \<2 x upper limit of normal).
11. Prior malignancy is acceptable if the patient is considered to be cured. In most cases this will mean a 5 year disease-free period.
12. Ability to give informed consent.
Exclusion Criteria:
1. Patients with active infection, pregnancy, lactating females, serious inter-current medical conditions including congestive heart failure, cardiac arrhythmias, or symptomatic coronary artery diseases are ineligible.
2. No prior treatment allowed. No prior thoracic radiation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00230451
Study Brief:
Protocol Section:
NCT00230451