Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

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Brief Title

Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

Official Title

Prospective Registry Study of Neoadjuvant Therapy in Conjunction With Liver Transplantation for Cholangiocarcinoma

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 treatment
      and to improve outcomes.
    



Study Type

Observational


Primary Outcome

Proportion of patients withdrawn due to toxicity and other treatment related events.

Secondary Outcome

 Proportion of patients who respond to treatment

Condition

Cholangiocarcinoma

Intervention

Observation data collection study.

Study Arms / Comparison Groups

 1
Description:  Patients with unresectable cholangiocarcinoma.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

August 12, 2005

Completion Date

December 31, 2022

Primary Completion Date

December 31, 2022

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

William C. Chapman, M.D., 314-362-7792, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00301379

Organization ID

05-0651 / 201102096


Responsible Party

Sponsor

Study Sponsor

Washington University School of Medicine


Study Sponsor

William C. Chapman, M.D., Principal Investigator, Washington University School of Medicine


Verification Date

July 2020