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CholangiocarcinomaNCT00301379

Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

An observational study of Cholangiocarcinoma, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholangiocarcinoma
What is being tested?
Observation data collection study.
How many people
59 participants
Where
1 siteUnited States
Study dates
12 Aug 2005to 6 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Primary care clinic.

Who may be able to join

  • Diagnosis of cholangiocarcinoma that has been 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.
  • Listed for OLT for hilar cholangiocarcinoma
  • Tumor/stricture is above the cystic duct and is unresectable.
Show all 9Show fewer
  • 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.
  • >/= 18 years of age.
  • Willing and able to provide written informed consent.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Being tested
Observation data collection study.
Keywords
Cholangiocarcinoma, Observational
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observation data collection study.Other

    This is a data collection study where the main purpose is to collect information about the treatments patients receive for their unresectable cholangiocarcinoma.

Study groups in NCT00301379
Study groupRoleWhat they receive
1Patients with unresectable cholangiocarcinoma.
Receives: Other: Observation data collection study.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Completion of treatment for all patients (estimated to be 18 years total)

Secondary outcomes (3)

  1. Proportion of patients who respond to treatment

    -Response is defined as an absence of progressive disease or metastasis, so that the patient remains a candidate for liver transplantation

    Measured: Completion of treatment for all patients (estimated to be 18 years total)

  2. Overall survival

    Measured: Completion of treatment for all patients (estimated to be 18 years total)

  3. Disease-free survival

    Measured: Completion of treatment for all patients (estimated to be 18 years total)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2006 (estimated)
  2. Study start12 Aug 2005
  3. Primary completion6 Jun 2023
  4. Study completion6 Jun 2023

Why it stopped: Low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00301379
Sponsor's protocol ID
05-0651 / 201102096
Status last verified
Jun 2023
First submitted
8 Mar 2006
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Heimbach JK, Haddock MG, Alberts SR, Nyberg SL, Ishitani MB, Rosen CB, Gores GJ. Transplantation for hilar cholangiocarcinoma. Liver Transpl. 2004 Oct;10(10 Suppl 2):S65-8. doi: 10.1002/lt.20266.

    PubMed 15382214

  • Jarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz BS J, Youssef BA M, Klimstra D, Blumgart LH. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg. 2001 Oct;234(4):507-17; discussion 517-9. doi: 10.1097/00000658-200110000-00010.

    PubMed 11573044

  • Casavilla FA, Marsh JW, Iwatsuki S, Todo S, Lee RG, Madariaga JR, Pinna A, Dvorchik I, Fung JJ, Starzl TE. Hepatic resection and transplantation for peripheral cholangiocarcinoma. J Am Coll Surg. 1997 Nov;185(5):429-36. doi: 10.1016/s1072-7515(97)00088-4.

    PubMed 9358085

  • De Vreede I, Steers JL, Burch PA, Rosen CB, Gunderson LL, Haddock MG, Burgart L, Gores GJ. Prolonged disease-free survival after orthotopic liver transplantation plus adjuvant chemoirradiation for cholangiocarcinoma. Liver Transpl. 2000 May;6(3):309-16. doi: 10.1053/lv.2000.6143.

    PubMed 10827231

  • Brandsaeter B, Isoniemi H, Broome U, Olausson M, Backman L, Hansen B, Schrumpf E, Oksanen A, Ericzon BG, Hockerstedt K, Makisalo H, Kirkegaard P, Friman S, Bjoro K. Liver transplantation for primary sclerosing cholangitis; predictors and consequences of hepatobiliary malignancy. J Hepatol. 2004 May;40(5):815-22. doi: 10.1016/j.jhep.2004.01.002.

    PubMed 15094230

  • Madariaga JR, Iwatsuki S, Todo S, Lee RG, Irish W, Starzl TE. Liver resection for hilar and peripheral cholangiocarcinomas: a study of 62 cases. Ann Surg. 1998 Jan;227(1):70-9. doi: 10.1097/00000658-199801000-00011.

    PubMed 9445113

  • Shimoda M, Farmer DG, Colquhoun SD, Rosove M, Ghobrial RM, Yersiz H, Chen P, Busuttil RW. Liver transplantation for cholangiocellular carcinoma: analysis of a single-center experience and review of the literature. Liver Transpl. 2001 Dec;7(12):1023-33. doi: 10.1053/jlts.2001.29419.

    PubMed 11753904

  • Goldstein RM, Stone M, Tillery GW, Senzer N, Levy M, Husberg BS, Gonwa T, Klintmalm G. Is liver transplantation indicated for cholangiocarcinoma? Am J Surg. 1993 Dec;166(6):768-71; discussion 771-2. doi: 10.1016/s0002-9610(05)80696-8.

    PubMed 8273866

  • Hassoun Z, Gores GJ, Rosen CB. Preliminary experience with liver transplantation in selected patients with unresectable hilar cholangiocarcinoma. Surg Oncol Clin N Am. 2002 Oct;11(4):909-21. doi: 10.1016/s1055-3207(02)00036-4.

    PubMed 12607579

  • Sudan D, DeRoover A, Chinnakotla S, Fox I, Shaw B Jr, McCashland T, Sorrell M, Tempero M, Langnas A. Radiochemotherapy and transplantation allow long-term survival for nonresectable hilar cholangiocarcinoma. Am J Transplant. 2002 Sep;2(8):774-9. doi: 10.1034/j.1600-6143.2002.20812.x.

    PubMed 12243499

  • Tsavaris, Inv New Drugs, 22:193, 2004;Verdarame, Anti-Cancer Drugs, 11:707,2000.

  • Picus, Proc ASCO, 13:208, 1994.

  • Broome U, Olsson R, Loof L, Bodemar G, Hultcrantz R, Danielsson A, Prytz H, Sandberg-Gertzen H, Wallerstedt S, Lindberg G. Natural history and prognostic factors in 305 Swedish patients with primary sclerosing cholangitis. Gut. 1996 Apr;38(4):610-5. doi: 10.1136/gut.38.4.610.

    PubMed 8707097

  • Valle JW WH, Palmer DD, Cunningham D, Anthoney DA, Maraveyas A, Hughes SK, Roughton JA, Bridgewater JA: Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial). J Clin Oncol 27:15s, 2009 (suppl, abstr 4503), 2009

  • Williams KJ, Picus J, Trinkhaus K, Fournier CC, Suresh R, James JS, Tan BR. Gemcitabine with carboplatin for advanced biliary tract cancers: a phase II single institution study. HPB (Oxford). 2010 Aug;12(6):418-26. doi: 10.1111/j.1477-2574.2010.00197.x.

    PubMed 20662793

Questions about this trial

What is this clinical trial studying?

An observational study of Cholangiocarcinoma, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients withdrawn due to toxicity and other treatment related events. (time frame: Completion of treatment for all patients (estimated to be 18 years total)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00301379, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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