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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT00040859
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists
* Unresectable disease
* Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach
* Measurable disease
* No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* AST no greater than 3 times ULN
* Alkaline phosphatase no greater than 2 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No New York Heart Association class III or IV heart disease
Other:
* Able to swallow capecitabine
* No unresolved gastrointestinal bleeding
* No uncontrolled infection
* No chronic debilitating disease
* No peripheral neuropathy grade 2 or greater
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy or biological therapy for recurrent or metastatic disease
* No concurrent biologic agents
Chemotherapy:
* No prior chemotherapy for recurrent or metastatic disease
* Prior adjuvant or neoadjuvant chemotherapy (including combination chemotherapy and radiotherapy) allowed
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Chemotherapy
* No prior radiotherapy for recurrent or metastatic disease
* No prior radiotherapy to more than 25% of the bone marrow
* Prior adjuvant or neoadjuvant radiotherapy allowed
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* More than 4 weeks since prior abdominal exploration with surgical resection
* More than 3 weeks since prior abdominal exploration without surgical resection
Other:
* No concurrent oral cryotherapy during oxaliplatin administration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00040859
Study Brief:
Protocol Section:
NCT00040859