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 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT01674959
Eligibility Criteria:
Inclusion Criteria:
1. Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction.
2. Age of 18 to 75, Karnofsky score higher than 70.
3. Postoperative histologically conformed metastasis in perigastric lymph nodes and/or tumor invasion to muscularis propria or subserosa, without positive incisal margin. Stage II/III(AJCC 7th).
4. No severe functional damage of major organ, normal blood cell, normal liver and kidney function.
5. No clinical findings of distant metastasis.
6. Predictive survival time longer than 6 months.
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Exclusion Criteria:
1. Peritoneal carcinomatosis, as diagnosed by mandatory laparoscopy or distant metastasis
2. Concurrent treatment with other experimental drugs or other anti-cancer therapy, or treatment within a clinical trial within 30 days prior to trial entry
3. Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, no myocardial infarction within the last 12 months, unstable angina pectoris, or significant arrhythmia)
4. Active or uncontrolled infection.
5. Definitive contraindications for the use of corticosteroids as premedication
6. Prior systemic (chemo- or targeted) treatment. Prior radiotherapy to the upper abdomen
7. Any contraindication to treatment with cetuximab, capecitabine or cisplatin
8. Previous malignancy within 5 years, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
9. Known hypersensitivity against any of the study drugs ( capecitabine)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01674959
Study Brief:
Protocol Section:
NCT01674959