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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT00464893
Eligibility Criteria:
Inclusion Criteria:
* signed and dated informed consent
* male or female patient at an age of 18 years or older
* patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
* TNM-staging at screening of T3/T4, N+/-, M0 or T2, N+, M0
* indication and eligibility for a neoadjuvant chemotherapeutic regimen featuring three cycles of ECX with 21 days per cycle
* intended curative gastrectomy
* Karnofsky index \> 70
Exclusion Criteria:
* Exposure to prior cancer therapy or planned adjuvant chemo- or radiotherapy of the current gastric cancer
* prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
* previous use of non-humanized monoclonal mouse or rat antibodies
* treatment with another investigational product during this study or during the last 30 days prior to study start
* presence of distant metastases
* presence of constant immunosuppressive therapy
* history of pancreas resection (also partial) or thoracotomy
* presence of any acute or chronic systemic infection
* patient with a bowel obstruction within the last 30 days
* known contraindications to any of the planned ECX chemotherapeutics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00464893
Study Brief:
Protocol Section:
NCT00464893