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 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT00352833
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent
* Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
* Intended curative gastrectomy ('en-bloc´-R0-resection considering the standard D2-scheme)
* Serosal infiltration (T3/T4, N+/-, M0) confirmed by immediate section with histopathologic assessment during surgery
* Karnofsky index \>= 70
* Negative pregnancy blood test at screening in women with childbearing potential
Exclusion Criteria:
* Presence of distant metastases
* Macroscopic and microscopic residual tumor present after surgery
* State after pancreas resection or thoracotomy
* Exposure to prior cancer therapy or planned adjuvant chemo-or radiotherapy of the current gastric cancer
* Previous treatment with non-humanized mouse or rat monoclonal antibodies
* Known/suspected hypersensitivity to catumaxomab or similar antibodies
* Any cancer disease or any cancer treatments within the last 5 years
* Presence of constant immunosuppressive therapy
* Inadequate renal function (creatinine \> 1.5 x ULN)
* Inadequate hepatic function (AST or ALT \> 2.5 x ULN or bilirubin \>= 1.5 x ULN)
* Platelets \< 75000 cells/mm³; absolute neutrophil count \< 1500 cells/mm³
* Patient had a bowel obstruction within the last 30 days
* Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
* Presence of any acute or chronic systemic infection
* Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study
* Patient is an employee of any involved study investigator or any involved institution including the study sponsor
* Parallel participation in another clinical trial or previous participation in this study
* Treatment with another investigational product during this study or during the last 30 days prior to study start
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00352833
Study Brief:
Protocol Section:
NCT00352833