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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT00504192
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically or cytologically confirmed biliary tract adenocarcinoma
2. Inoperable disease as defined by:
* Localized disease in a portion of the liver that does not allow the possibility of complete surgical removal of the tumor with a clear resection margin.
* Presence of metastatic lesion
* Unresectable recurrent tumor after curative resection
* anatomically resectable but inoperable associated with medical condition
3. Biliary obstruction controlled
4. Minimum life expectancy of 12 weeks.
5. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable lesion present by imaging study
6. Age over 18 years
7. ECOG performance status of \* 2.
8. Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤3xUNL; AST and/or ALT \< 5x UNL; Creatinine\< 1.5mg/dl or creatinine clearance \>50 ml/mins
9. Consent form signed and dated prior to study specific procedures.
10. Subject able to comply with the scheduled follow-up and with the management of toxicities.
Exclusion Criteria:
1. Decompensated Cirrhosis or stage C (Index \> 10) according to the Child-Pugh Classification
2. Prior systemic chemotherapy
3. Subject with reproductive potential (M/F) not using adequate contraceptive measures.
4. Pregnancy and breast-feeding.
5. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
6. Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
7. Symptomatic or uncontrolled brain metastasis
8. Other concomitant anticancer agent, including Tamoxifen and Interferon.
9. Subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons.
10. Participation in another clinical study or within 30 days before inclusion.
11. History of severe hypersensitivity reactions to gemcitabine or oxaliplatin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00504192
Study Brief:
Protocol Section:
NCT00504192