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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT00319735
Eligibility Criteria:
Inclusion Criteria:
* Pathological diagnosis of either squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction.
* Clinical stage IIA, IIB or III without metastatic disease
* Patients must have documented EGFR status or have tumor tissue available for assessment of EGFR status by IHC
* Patients must be surgical candidates as determined by surgical consult.
* Patients must agree to surgery.
* ECOG performance status 0 or 2
* Absolute neutrophil count (ANC) \> 1,000 mm3
* Platelet count \> 75,000 mm3· Hemoglobin \> 10g/dL
* Bilirubin \< 2.5 X upper limit of normal
* AST (SGOT) or ALT (SGPT) \< 5.0 ´ upper limit of normal
* Creatinine \< 2.0 X upper limit of normal
Exclusion Criteria:
* No history of or current brain metastasis.
* No significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
* No history of interstitial pneumonitis or pulmonary fibrosis, or suspicion of interstitial pneumonitis or pulmonary fibrosis on imaging.
* No concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
* No prior use of radiation or chemotherapy for cancer of the esophagus or GE junction
* No prior therapy that specifically and directly targets the EGFR pathway (such as kinase inhibitors and antibodies directed against the HER family receptors).
* No prior severe infusion reaction to a monoclonal antibody.
* No major surgery within 28 days prior to being registered for protocol therapy.
* No clinically significant infections as judged by the treating investigator.
* No acute hepatitis or known HIV.
* No other active malignancies.
* Negative pregnancy test.
* No female patients currently breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00319735
Study Brief:
Protocol Section:
NCT00319735