Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

Terminated

• Conditions: Cholangiocarcinoma
• Interventions: Other: Observation data collection study.

• Registration Number: NCT00301379
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This is an observational study intended to validate results of a previous study done at the Mayo Clinic. Patients are treated with combination chemotherapy and radiation and maintained on oral Xeloda until they can receive liver transplant. A staging laparotomy is performed before chemoradiation in order to identify patients who will most benefit from the tr...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-08-12
• Study First Submitted: 2006-03-08
• Study First Submitted QC: 2006-03-08
• Study First Posted: 2006-03-10
• Status Verified: 2023-06
• Primary Completion: 2023-06-06
• Study Completion: 2023-06-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1. Diagnosis of cholangiocarcinoma that has been established preoperatively by at least one of the following criteria:

   1. A positive brush cytology or biopsy result obtained at the time of cholangiography;
   2. Fluorescence in situ hybridization demonstrating aneuploidy;
   3. A serum CA 19-9 value greater than 100 U/mL in the presence of a radiographically characteristic malignant stricture in the absence of cholangitis.
   4. Listed for OLT for hilar cholangiocarcinoma

2. Tumor/stricture is above the cystic duct and is unresectable.

3. A suitable candidate for orthotopic liver transplantation as judged by the liver transplant team. All 3 treatment modalities are not needed to confirm eligibility for this registry trial.

4. >/= 18 years of age.

5. Willing and able to provide written informed consent.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Observation data collection study.	Patients with unresectable cholangiocarcinoma.

Primary Outcome Measures

Name	Time	Method
Proportion of patients withdrawn due to toxicity and other treatment related events.	Completion of treatment for all patients (estimated to be 18 years total)

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who respond to treatment	Completion of treatment for all patients (estimated to be 18 years total)	-Response is defined as an absence of progressive disease or metastasis, so that the patient remains a candidate for liver transplantation
Overall survival	Completion of treatment for all patients (estimated to be 18 years total)
Disease-free survival	Completion of treatment for all patients (estimated to be 18 years total)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States