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Hilar CholangiocarcinomaNCT01549795

Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy

A study testing Liver transplantation, 45 Gy external radiations and Endoluminal bile duct Brachytherapy in people with Hilar Cholangiocarcinoma and Primary Sclerosing Cholangitis, run by Azienda Ospedaliera di Padova at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be subjected to liver transplantation after a neoadjuvant multimodal therapy protocol. Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent in patients with primary sclerosing cholangitis… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Liver transplantation, 45 Gy external radiations and Endoluminal bile duct Brachytherapy
How many people
33 participants
Where
1 siteItaly
Study dates
Jan 2012to Jul 2013
Phase
Interventional
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Older than 18 years
  • Male or female
  • Diagnosis of Cholangiocarcinoma using:
  • PTBD biopsy or Brushing cytology
  • Ca 19-9>100mg/ml and/or liver mass at CT or MRI with malignant stenosis apperance at Cholangiography,
  • Non resectable tumour araising above the cystic duct
Show all 10Show fewer
  • Absence of intra and extra hepatic metastasis
  • ECOG score(Eastern Cooperative Oncology Group) 0
  • ASA score (American Society of Anesthesiologists) ≤ 3
  • Ability to understand and willingness to sign the written informed consent form (ICF)

Who cannot join

  • Intrahepatic Cholangiocarcinoma
  • Non controlled infection
  • Previous radio or chemotherapy
  • Previsous bile duct resection or attempt to resection
  • Intra and/or extrahepatic metastasis
  • Preivious malignant neoplasm (within 5 years)
  • Execution of trans peritoneal biopsy
  • Tumour diameter more than 3 cm

Trial locations and contacts

1 site in 1 country.

Umberto Cillo, MD contact

+390498218547

cillo@unipd.it

Enrico Gringeri, MD contact

+390498218547

enrico.gringeri@unipd.it

Italy1 site, 1 recruiting

  • Azienda Ospedaliera di Padova

    Padova, Padova, 35100

    Umberto Cillo, MD, +390498218547, cillo@unipd.it

    Enrico Gringeri, MD, +390498218547, enrico.gringeri@unipd.it

    Recruiting

Other trials in Italy

About this study

Official title: Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante

Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be subjected to liver transplantation after a neoadjuvant multimodal therapy protocol.

Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent in patients with primary sclerosing cholangitis (PSC), who carry an 8%-12% risk of developing this type of neoplasm. Only a minority of patients are suitable for resection partly because of the anatomic position of the tumor (which often arises from the bile duct bifurcation) and partly because of the frequently coexisting liver disease. In fact, CC is currently considered a major contraindication to liver transplantation (OLT) at the majority of centers, given a 5-year survival rate of 0%-35%.

New strategies have been developed for the treatment of this kind of cancer arising in PSC. The Nebraska University group showed a 1 and 3 years survival of 55 and 45 % combining a neoadjuvant intra bile duct barchytherapy and 5-FU based chemotherapy with liver transplantation. University of Pittsburg proposed also a neoadjuvant protocol prior to liver transplantation based on systemic chemotherapy and external radiotherapy reporting a 53% 5 years survival. More convincing results come from the Mayo Clinic. An accurate selection of patients and a proper neoadjuvant multimodal therapy (chemotherapy, external radiotherapy and intraluminal bile duct brachytherapy) lead to a 80% 5 years survival after liver transplantation.

Being tested
Liver transplantation, 45 Gy external radiations, Endoluminal bile duct Brachytherapy, Capecitabine, Pre liver transplantation laparoscopic hand assisted staging
Keywords
Liver transplantation, Neoadjuvant radio- chemo-therapy
Medical subject headings
Klatskin Tumor, Cholangitis, Sclerosing

What participants receive

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

  • Liver transplantationProcedure or surgery

    Liver transplantation using classic technique and avoiding proximal ilum dissection. The donor hepatic artery will be anastomosed to a jump graft connected to the Aorta. In case of positive margin of the bile duct at a frozen section analysis the liver transplant will be performed after an adjunctive pancreatodudodenctomy

  • 45 Gy external radiationsRadiation

    45 Gy in 30 fractions, 1,5 Gy twice a day) and 5-FU iv infusion- 3 week treatment

  • Endoluminal bile duct BrachytherapyRadiation

    Brachytherapy (20 Gy a 1 cm in 20-25h) - administered 2 weeks after radiotherapy completion

  • CapecitabineDrug

    Capecitabine - administered till liver transplantation

  • Pre liver transplantation laparoscopic hand assisted stagingProcedure or surgery

    Pre liver transplantation laparoscopic hand assisted staging for sampling hepatic artery lymph nodes and assessing peritoneal disease.

What is being measured

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

  1. Percentage of patients free of disease at 24 months post-transplant

    Measured: 24 months

  2. Time to recurrence after liver transplant

    Measured: 24 months

Secondary outcomes (3)

  1. Progression disease free survival

    Measured: 24 months

  2. Overall 2 years survival after liver transplantation

    Measured: 24 months

  3. Complication rate due to radiotherapy (Hepatic artery thrombosis and Portal vein thrombosis)

    Measured: 24 months

Timeline

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

  1. First posted9 Mar 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2013 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01549795
Sponsor's protocol ID
2372P
Status last verified
Jul 2012
First submitted
7 Mar 2012
Last updated
18 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Hemming AW, Reed AI, Fujita S, Foley DP, Howard RJ. Surgical management of hilar cholangiocarcinoma. Ann Surg. 2005 May;241(5):693-9; discussion 699-702. doi: 10.1097/01.sla.0000160701.38945.82.

    PubMed 15849505

  • Rea DJ, Heimbach JK, Rosen CB, Haddock MG, Alberts SR, Kremers WK, Gores GJ, Nagorney DM. Liver transplantation with neoadjuvant chemoradiation is more effective than resection for hilar cholangiocarcinoma. Ann Surg. 2005 Sep;242(3):451-8; discussion 458-61. doi: 10.1097/01.sla.0000179678.13285.fa.

    PubMed 16135931

  • Rosen CB, Heimbach JK, Gores GJ. Liver transplantation for cholangiocarcinoma. Transpl Int. 2010 Jul;23(7):692-7. doi: 10.1111/j.1432-2277.2010.01108.x. Epub 2010 May 20.

    PubMed 20497401

  • Hamilton JP. Epigenetic mechanisms involved in the pathogenesis of hepatobiliary malignancies. Epigenomics. 2010 Apr 1;2(2):233-243. doi: 10.2217/epi.10.9.

    PubMed 20556199

Questions about this trial

What is this clinical trial studying?

A study testing Liver transplantation, 45 Gy external radiations and Endoluminal bile duct Brachytherapy in people with Hilar Cholangiocarcinoma and Primary Sclerosing Cholangitis, run by Azienda Ospedaliera di Padova at 1 site in Italy.

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 10 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Jul 2012. 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 Italy. 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?

Results are not available in the source record.

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

Contact Umberto Cillo, MD (+390498218547, cillo@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients free of disease at 24 months post-transplant (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT01549795, which also lists 4 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 18 Jul 2012.

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