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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT00304135
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of cancer of the biliary tract by 1 of the following methods:
* Histologic confirmation
* Stenosis of the biliary tract by MRI, CT scan, or ECHO
* Unresectable disease
* Amenable to radiotherapy
* No visceral metastases by imaging
* Hepatic adenopathies that can be included in a radiation field allowed
* No known ampulla of Vater or pancreatic cancer involving the biliary tract
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Creatinine \< 1.5 mg/dL
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Prothrombin time \> 70%
* Bilirubin ≤ 2.9 mg/dL (after hepatic draining, if needed)
* No unstable angina
* No symptomatic cardiac insufficiency
* No other comorbidity that would preclude study therapy
* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* No prior hydatid cyst or alveolar echinococciasis
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
* No recent biliary surgery
* No hepatic intra-arterial chemotherapy
* No prior anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00304135
Study Brief:
Protocol Section:
NCT00304135