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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT00985556
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the stomach
* Unresectable advanced disease or recurrent disease after resection
* At least one radiographically documented (CT scan or MRI) measurable or evaluable lesion in a previously non-irradiated area according to RECIST
* No clinical evidence of brain metastases or history of other CNS disease unless adequately treated
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Estimated life expectancy \> 3 months
* Hemoglobin ≥ 9 g/dL
* White blood cell ≥ 4,000/µL
* ANC ≥ 2,000/µL
* Platelets ≥ 100,000/µL
* Bilirubin ≤ 1.25 times upper limit of normal (ULN) (≤ 2.0 times ULN if hepatic metastasis present)
* Serum creatinine ≤ 1.5 times ULN
* Creatinine clearance ≥ 60 mL/min
* AST/ALT ≤ 3.0 times ULN (≤ 5.0 times ULN if hepatic metastasis present)
* Alkaline phosphatase ≤ 3.0 times ULN (≤ 5.0 times ULN if bone metastasis present)
* Must have an intact gastrointestinal tract
* Able to take oral medications
* No medically uncontrolled severe infections or complications
* No prior malignancy other than gastric cancer in the last 5 years except for basal cell cancer of the skin or preinvasive cancer of the cervix
* Not pregnant or nursing
* No neuropathy ≥ grade 2
* No clinically relevant heart disease
* No evidence of past medical history or psychosocial dysfunction that contraindicates the use of an investigational drug or puts the patient at risk
* No dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
* No uncontrolled hepatitis B or C, chronic liver disease, or diabetes mellitus
* No other evidence of inappropriate suspicious condition
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for advanced or recurrent disease
* Prior adjuvant chemotherapy allowed if finished \> 6 months before start of study treatment
* No prior therapeutic radiotherapy
* Prior palliative radiotherapy allowed if it was not done for primary, evaluable, or intraabdominal lesions
* No prior capecitabine or oxaliplatin
* No other concurrent chemotherapy or radiotherapy (except localized radiotherapy for pain relief)
* No concurrent chemically related analogues, such as warfarin, phenytoin, or allopurinol
* No concurrent steroid therapy except as follows:
* Prophylactic use for hypersensitivity control or antiemetic purpose allowed
* Chronic low dose of steroid (less than methylprednisolone 20 mg or equivalent dose) allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00985556
Study Brief:
Protocol Section:
NCT00985556