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 @ 2:30 PM
Ignite Modification Date:
2025-12-24 @ 2:30 PM
NCT ID:
NCT00551759
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed adenocarcinoma of the esophagus (\> 20 cm below the incisors) or gastroesophageal (GE) junction, untreated with chemotherapy, radiation therapy, and surgery. Endoscopy with biopsy and dilation was permitted.
* Tumor stage T2N0M0, T3N0M0, T1-3N+M0, or T1-3N0-1M1A as determined by imaging studies performed no greater than 4 weeks prior to registration, and biopsy, where appropriate. Celiac nodal metastasis (M1A disease) was permitted if other eligibility criteria were met. Data from endoscopic ultrasound and endoscopy were required for staging. The following imaging was required: CT scan with IV contrast and PET or PET+CT. If the PET/CT incorporates CT with IV contrast, then a separate CT is not required. If laparoscopy or other relevant procedures were performed, the data were to be incorporated into stage assignment. Any lesion suspicious for metastasis had to have been biopsied to prove eligibility.
* Tumor extension into cardia, if present, must have been no more than 2 cm.
* Tumors must have been considered surgically resectable (T1-3, not T4).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Granulocytes \> 1,000/ mm³
* Platelets \> 100,000 μL
* Creatinine normal or creatinine clearance \> 60 mL/min
* Total serum bilirubin \< 1.5 mg/dL
* Fertile patients must use effective contraception
* History of a curatively treated malignancy from which the patient has been disease-free for ≥ 2 years and has a survival prognosis of \> 5 years
Exclusion Criteria:
* Pregnant or breast-feeding.
* Prior severe infusion reaction to a monoclonal antibody
* prior therapy specifically and directly targeting the epidermal growth factor receptor (EGFR) pathway
* Hypertension
* Uncontrolled diabetes
* Intercurrent illness that would likely interfere with protocol therapy or prevent surgical resection
* Any of the following within the past 6 months:
* New York Heart Association class III-IV congestive heart failure
* Cerebrovascular accident or transient ischemic attack
* Unstable angina or myocardial infarction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00551759
Study Brief:
Protocol Section:
NCT00551759