International Registry on Cholangiocarcinoma Treatment

NCT01920503 | Unknown DMC

• 2 other identifiers: CHOLANGIO01CHOLANGIO100513
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Cholangiocarcinoma is a rare and very aggressive neoplasm that arises from the biliary epithelium, constitutes approximately 2% of all reported cancer, and accounts for about 3% of all gastrointestinal malignancies. Up to date, there are many modalities to diagnosis and treat with a range of sensitivity and specificity, and also the advantage and disadvantage of its modality. Cholangiocarcinoma has a poor prognosis. Surgical resection offers the only curative option and usually requires a major hepatic resection in addition to resection of the cholangiocarcinoma. Unfortunately, curative resection is possible in only about 30% of patients due to locally advanced disease, distant metastases or comorbidity in elderly patients. Even after resection, the recurrence rate is approximately 60%, resulting in a low 5-year overall survival (OS). Patients with intra-hepatic Cholangiocarcinoma (ICC) have a very limited benefit from systemic chemotherapy, indeed, in unresectable cholangiocarcinoma Overall Survival with systemic chemotherapy is less than 1 year. Since most cholangiocarcinoma patients develop distant metastases at late stages only, locoregional therapy is an interesting therapeutic strategy. Locoregional therapy studies in patients with intrahepatic cholangiocarcinoma employing radiofrequency ablation (RFA), transarterial chemoembolization (TACE) or external as well as internal radiation therapy yielded promising results in the last couple of years. TACE is safe and may be effective for prolonging the survival of patients with nonresectable combined hepatocellular carcinoma (HCC) -cholangiocarcinoma, as compared with the historically reported survivals of these patients. Tumor vascularity is highly associated with tumor response. The patient survival period after TACE for combined HCC-cholangiocarcinoma is significantly dependent on tumor size, tumor vascularity, Child-Pugh class, and presence or absence of portal vein invasion. Currently, few centers perform TACE therapy for unresectable Cholangiocarcinoma. Several European studies have reported the efficacy and safety TACE for ICC. The establishment of a registry to obtain the majority of Cholangiocarcinoma cases treated with locoregional approach within and outside Europe can help the investigators evaluate a larger and non-ambiguous sample population. This would help the investigators evaluate the technical success rates, clinical success rates, feasibility and safety of TACE for ICC.

Conditions

Cholangiocarcinoma

Keywords

cholangiocarcinoma; transarterial chemoembolization; doxorubicin; tumor response

Outcome Measures

Primary Outcomes (2)

• tumor response

  CT scan evaluated with RECIST 1.1

  12 months

• overall survival

  survival from start of treatment

  12 months

Secondary Outcomes (1)

• number adverse events

  4 months

Study Arms (1)

doxorubicin

Day +1: Lobar Infusion ( lobe with dominant disease) of Doxorubicin preloaded into 2 ml of 70-150 µm M1 microspheres. Second lobar infusion of Doxorubicin preloaded into 2 ml of 70-150 µm M1 microspheres can be administered at the same time contralaterally or in a further TACE Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated

Drug: Doxorubicin

Interventions

Doxorubicin DRUG

Doxorubicina is loaded at the concentration of 50-75 mg/mq onto 2 ml of 70-150 µm M1 microspheres and is infused by TACE method

Also known as: Adriamycin

doxorubicin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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; b) Fluorescence in situ hybridization demonstrating aneuploidy; c) 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 the study by a radiation oncologist, a medical oncologist, and the liver surgeon
• 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 - 75.
• Patient must provide written informed consent.

You may not qualify if:

• Patients with intrahepatic metastasis presenting liver involvement more than 75%
• Patients with uncontrolled infections (sepsis)
• Evidence of extrahepatic disease, including local lymph node metastasis (except peri-hilar nodes).
• History of another malignancy diagnosed within 5 years, excluding "in situ" skin and cervical cancers, without metastases.

Sponsors & Collaborators

• International Group of Endovascular Oncology: lead

Study Sites (1)

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore

Pesaro, 61122, Italy

RECRUITING

Related Publications (3)

• Aliberti C, Benea G, Tilli M, Fiorentini G. Chemoembolization (TACE) of unresectable intrahepatic cholangiocarcinoma with slow-release doxorubicin-eluting beads: preliminary results. Cardiovasc Intervent Radiol. 2008 Sep-Oct;31(5):883-8. doi: 10.1007/s00270-008-9336-2. Epub 2008 May 14.

  PMID: 18478290 RESULT

• Cantore M, Fiorentini G, Mambrini A, Rabbi C, Zamagni D, Carlone N, Manni A, Caudana R, Torri T. Regional combined with systemic chemotherapy in unresectable biliary tract cancers: a phase II study. J Exp Clin Cancer Res. 2003 Dec;22(4 Suppl):59-64.

  PMID: 16767908 RESULT

• Fiorentini G, Mambrini A, Sarti D, Cantore M, Mulazzani L, Mattioli GM, Guadagni S. Hepatic intra-arterial and systemic chemotherapy followed by maintenance therapy for the treatment of cholangiocarcinoma. Hepat Oncol. 2017 Apr;4(2):45-53. doi: 10.2217/hep-2017-0001. Epub 2017 Aug 31.

  PMID: 30191053 DERIVED

Related Links

• International group of endovascular oncology (IGEVO) website

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Giammaria Fiorentini, MD

  International Group of Endovascular Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giammaria Fiorentini

CONTACT

+390721364005; giammaria.fiorentini@ospedalimarchenord.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 12, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2020
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

IT (1)