Malignant biliary tract tumors
Conditions
Interventions
Group A:Biliary stenting with iodine-125 seeds implantation
Group B:Biliary stenting
Sponsors
First Affiliated Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. DISEASE CHARACTERISTICS: Histopathological/cytological diagnosis of nonresectable locally advanced, recurrent, or metastatic biliary tract carcinoma (intra- or extra-hepatic), or gallbladder carcinoma; Adequate biliary drainage, with no evidence of active uncontrolled infection; 2. PATIENT CHARACTERISTICS: ECOG performance status 0, 1, or 2, Estimated life expectancy > 3 months, Not pregnant or breasting-feeding; 3. PRIOR CONCURRENT THERAPY: Patients may have undergone a non-curative operation (i.e., R2 resection [with macroscopic residual disease] or palliative bypass surgery only) and fully recovered (1) Patients who have previously undergone curative surgery must have evidence of non-resectable disease relapse; (2) Patients may have received prior radiotherapy within the past 28 days (with or without radio-sensitizing low-dose chemotherapy) for localized disease and fully recovered; (3) Must have evidence of disease progression prior to inclusion in this study; (4) Patients may have received prior chemotherapy within the past 28 days and fully recovered.
Exclusion criteria
Exclusion criteria: 1. DISEASE CHARACTERISTICS: No brain metastases; 2. PATIENT CHARACTERISTICS: History of malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, or any early stage (stage l) malignancy adequately resected for cure greater than 5 years previously); with any evidence of severe or uncontrolled systemic diseases or laboratory findings that make the patient unsuitable for inclusion; with any psychiatric or other disorder likely to impact on informed consent; 3. PRIOR CONCURRENT THERAPY: Previous treatment with curative intent for current disease in the last 12 weeks (i.e., prior resection, radical radiotherapy, or chemotherapy); Previous treatment with experimental therapy for current disease in the last 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median survival time,;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life;progression-free survival; | — |
Countries
China
Contacts
Public ContactWei-xin REN
Outcome results
None listed