Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients
This study is currently recruiting participants.
Verified December 2012 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00301379
First received: March 8, 2006
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cholangiocarcinoma |
Other: Observation data collection study. |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- Primary (Phase I): Proportion of patients with grade 3 or 4 DLT. [ Time Frame: Approximately 5 years. ] [ Designated as safety issue: Yes ]
- Primary (Phase II): Rate of excess toxicity, proportion of patients with stable disease, or better, response at completion of chemoradiation, and the proportion of patients who are alive at 2 years after transplant. [ Time Frame: Approximatly 5 years. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Patients with unresectable cholangiocarcinoma.
|
Other: Observation data collection study.
This is a data collection study where the main purpose is to collect information about the treatments patients receive for their unresectable cholangiocarcinoma.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Primary care clinic.
Criteria
Inclusion Criteria:
The diagnosis of cholangiocarcinoma will be established preoperatively by at least one of the following criteria:
- A positive brush cytology or biopsy result obtained at the time of cholangiography;
- Fluorescence in situ hybridization demonstrating aneuploidy;
- 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.
- Tumor is above the cystic duct and is unresectable.
- 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.
- Maximum Eastern Cooperative Oncology Group performance status of 2 and a minimum daily caloric intake of 1200kcal.
- No evidence of metastatic disease.
- Between ages 18 - 70.
- Patient must provide written informed consent.
Exclusion Criteria:
- Patients with intrahepatic metastasis
- Patients with uncontrolled infections (sepsis)
- Patients undergoing prior attempts at resection
- Prior treatment with either irradiation or chemotherapy for this disease
- Evidence of extrahepatic disease, including local lymph node metastasis (except peri-hilar nodes).
- History of another malignancy diagnosed within 5 years, excluding superficial skin and cervical cancers
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301379
Contacts
| Contact: Laura Daigh, BA | 314-362-8547 | daighl@wudosis.wustl.edu |
| Contact: Kirsten Cady, BS, CCRP | 314-362-7773 | cadyk@wudosis.wustl.edu |
Locations
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Laura Daigh, BA 314-362-8547 daighl@wudosis.wustl.edu | |
| Contact: Kirsten Cady, BS, CCRP 314-362-7773 cadyk@wudosis.wustl.edu | |
| Principal Investigator: William C. Chapman, M.D. | |
| Sub-Investigator: Joel Picus, M.D. | |
| Sub-Investigator: Surendra Shenoy, MD | |
| Sub-Investigator: Jeffrey Lowell, MD | |
| Sub-Investigator: Jeffrey Crippin, MD | |
| Sub-Investigator: Mauricio Lisker-Mehlman, MD | |
| Sub-Investigator: Kevin Korenblat, MD | |
| Sub-Investigator: Riad Azar, MD | |
| Sub-Investigator: Benjamin Tan, MD | |
| Sub-Investigator: Steven Edmundowicz, MD | |
| Sub-Investigator: Sreenivasa Jonnalagadda, MD | |
| Sub-Investigator: Parag Parikh, M.D. | |
| Sub-Investigator: Elizabeth Brunt, M.D. | |
| Sub-Investigator: Steven Sorscher, M.D. | |
Sponsors and Collaborators
Washington University School of Medicine
Investigators
| Principal Investigator: | William C. Chapman, M.D. | Washington University School of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00301379 History of Changes |
| Other Study ID Numbers: | 05-0651 / 201102096 |
| Study First Received: | March 8, 2006 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
Cholangiocarcinoma Observational |
Additional relevant MeSH terms:
|
Cholangiocarcinoma Adenocarcinoma Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013