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Prospective Registry Study of Neoadjuvant Chemoradiation in Conjunction With Liver Transplantation for Cholangiocarcinoma With Induction Gemcitabine, Followed by 3D Conformal Radiation With 5-FU as a Radiosensitizer, and Maintenance Xeloda Therapy Until Liver Transplantation


N/A
18 Years
70 Years
Open (Enrolling)
Both
Cholangiocarcinoma

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Trial Information

Prospective Registry Study of Neoadjuvant Chemoradiation in Conjunction With Liver Transplantation for Cholangiocarcinoma With Induction Gemcitabine, Followed by 3D Conformal Radiation With 5-FU as a Radiosensitizer, and Maintenance Xeloda Therapy Until Liver Transplantation


Inclusion Criteria:



1. The diagnosis of cholangiocarcinoma will be 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.

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

3. Patient is a suitable candidate for OLT and judged a good candidate for the study by
a radiation oncologist, a medical oncologist, and the liver transplant team.

4. Maximum Eastern Cooperative Oncology Group performance status of 2 and a minimum
daily caloric intake of 1200kcal.

5. No evidence of metastatic disease.

6. Between ages 18 - 70.

7. Patient must provide written informed consent.

Exclusion Criteria:

1. Patients with intrahepatic metastasis

2. Patients with uncontrolled infections (sepsis)

3. Patients undergoing prior attempts at resection

4. Prior treatment with either irradiation or chemotherapy for this disease

5. Evidence of extrahepatic disease, including local lymph node metastasis (except
peri-hilar nodes).

6. History of another malignancy diagnosed within 5 years, excluding superficial skin
and cervical cancers

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Primary (Phase I): Proportion of patients with grade 3 or 4 DLT.

Outcome Time Frame:

Approximately 5 years.

Safety Issue:

Yes

Principal Investigator

William C. Chapman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

05-0651 / 201102096

NCT ID:

NCT00301379

Start Date:

November 2005

Completion Date:

May 2015

Related Keywords:

  • Cholangiocarcinoma
  • Cholangiocarcinoma
  • Observational
  • Cholangiocarcinoma

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110