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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT01404156
Eligibility Criteria:
Inclusion Criteria:
* adenocarcinoma of esophagus or gastroesophageal junction; -cT1N1-3 or T2-4Nx; M0 by American Joint Committee on Cancer (AJCC) 7th Edition staging classification
* proximal portion of the tumor at least 20 cm from the incisors on endoscopy, and extend no greater than 2 cm into the gastric cardia
* tumor length \< 8cm; diameter \< 5 cm
* age \> 18 years
* absolute neutrophil count (ANC) ≥ 1.5 x 109 / L
* platelet count \> 100 x 109 / L
* creatinine clearance \> 50 ml / min
* bilirubin \< 1.5x upper limit normal
* FEV1 \> 1.0 L
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria
* positive serum / urine pregnancy test for females of childbearing age
* previous primary / recurrent malignancy in last 5 years (history of previous / current non-melanoma skin cancer or cervical in-situ carcinoma in last 5 years acceptable for inclusion in trial)
* previous chemotherapy for esophageal cancer
* previous radiation therapy that would overlap required radiation fields
* major systemic illness(es) that would limit life expectancy \<2 years
* psychiatric / cognitive illness that would limit ability to give informed consent
* (Patients will be reviewed by both a medical and radiation oncologist and deemed fit to undergo either neoadjuvant chemotherapy or chemoradiation, respectively)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01404156
Study Brief:
Protocol Section:
NCT01404156