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:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT01989858
Eligibility Criteria:
Inclusion Criteria:
* age \>18 years
* Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 0-1
* T3 or T4 carcinoma without lymphnode involvement (N0) and any T-stage with (N+) lymphnode involvement
* no distant metastases (M0)
* fitness to receive CHT and CHT-RTX
* no peripheral neuropathy greater than grade 1
* absence of peritoneal carcinomatosis
* written informed consents (one for each trial) given before the randomization, according to International Conference on Harmonisation/Good Clinical Practice (ICH/GCP)
Exclusion Criteria:
* adenocarcinoma of the gastro-esophageal junction
* previous CHT or RTX
* abnormal haematological, hepatic or renal functions, assessed within 7 days prior to randomization
* lymphnode metastases (biopsy proof, if possible) outside the loco-regional field, such as supraclavicular, mediastinal or para-aortic nodes
* positive peritoneal cytology
* clinical significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), instable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
* lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
* history or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or patients at high risk from treatment complications
* pregnancy or breast feeding. Women of childbearing potential and their parents must be willing to practice acceptable methods of birth control to prevent pregnancy
* presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and f-up schedule
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01989858
Study Brief:
Protocol Section:
NCT01989858