International Registry on Cholangiocarcinoma Treatment (CHOLANGIO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by International Group of Endovascular Oncology
Sponsor:
Information provided by (Responsible Party):
International Group of Endovascular Oncology
ClinicalTrials.gov Identifier:
NCT01920503
First received: August 7, 2013
Last updated: August 10, 2013
Last verified: August 2013
  Purpose

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. As physicians, we should be able to assess and choose promptly which modality is best for our patient, even for palliative care. Treatment modalities are surgery and non-surgery like adjuvant chemotherapy, radiation, chemoradiation, radiotherapy, TACE, intra-arterial chemoinfusion, photodynamic therapy, liver transplantation, and palliative therapy. The choice of treatment varies individually.

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.

Locoregional therapies have been shown to be effective in patients with ICC. Trans arterial chemoembolization (TACE),for example, is safe in patients with normal liver function, and results in a prolongation of progression free survival (PFS) and OS. Local tumour control may prolong OS and can be achieved by locoregional interventions applied either sequentially or in combination with systemic chemotherapies.

TACE is also used as postoperative adjuvant therapy for cholangiocarcinoma, resulting in prolonged survival in patients with tumour size ≥ 5 cm or advanced primary tumor, regional nodes, metastasis (TNM) stage.

TACE offers also greater survival benefits than supportive treatment for the palliative treatment of unresectable ICC.

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.

All hospitals of IGEVO operating on patients with cholangiocarcinoma are eligible to take part in the Registry.


Condition Intervention
Cholangiocarcinoma
Drug: Doxorubicin

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: International Registry on Cholangiocarcinoma Treatment

Resource links provided by NLM:


Further study details as provided by International Group of Endovascular Oncology:

Primary Outcome Measures:
  • tumor response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number adverse events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

Study Design: Prospective observational study

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

Secondary objectives: To create an international Registry including patients undergoing locoregional treatments, to correlate tumour characteristics with outcome, survival and prognosis; to identify criteria for guiding therapy including TACE, chemoinfusion and other locoregional treatments

Treatment modalities for TACE

Day -1 Doxorubicina 50-75 mg/mq has been charged onto 2 ml of 70-150 µm M1 microspheres at Pharmacy.

Day -1 : prehydration, antibiotic prophylaxis and setting up of a therapeutic scheme appropriate for analgesic prophylaxis (3-day duration) as previously reported 1 vial of tropisetron (diluted in 100ml of physiological solution) administered by slow drip Day 0: Upon admittance to the radiology room, the patient receive morphine hydrochloride 10 mgr diluted in 100 ml of salin solution i.v. (to be repeated one hour after the procedure and if necessary also after 6 hours).

Tropisetron i.v. if needed. Intra-arterial premedication with 2.5 mgr of verapamil 2.5 mgr diluted in 4 ml of normal saline solution followed by 4 ml of lidocaine 2%.

Selected arterial Infusion (considering tumor uptake and dominant disease) of doxorubicina 50-75 mg preloaded into 2 ml of 70-150 µm M1 microspheres.

Second infusion of doxorubicin at the same dose into 2 ml of 70-150 µm M1 microspheres can be administered in a further TACE (oncologist's planning of cure).

Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated

Evaluation of response

Response must be assessed by repeating the following examinations at Day 30, Day 90 and Day 120 after start of treatment:

Chest-abdomen CAT scan with and without contrast medium (refer to Section 4). Evaluation will be based on the Response Evaluation Criteria In Solid Tumors (RECIST) cancer markers (CEA), Cancer Antigen (CA) 19.9)

Assessment of quality of life The Edmonton Symptom Assessment System (ESAS) is used to monitor health conditions and quality of life.

The questionnaire must be filled in by the patient unaided by family members or by health care personnel, over a period of about 15 minutes. Assessment of quality of life will be performed during the baseline visit and at Day 30, Day 60 and Day 120 from start of treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  1. 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.
  2. Tumor is above the cystic duct and is unresectable.
  3. Patient is a suitable candidate for the study by a radiation oncologist, a medical oncologist, and the liver surgeon
  4. Maximum Eastern Cooperative Oncology Group performance status of 2 and a minimum daily caloric intake of 1200kcal.
  5. No evidence of metastatic disease.
  6. Between ages 18 - 75.
  7. Patient must provide written informed consent.

Exclusion Criteria:

  1. Patients with intrahepatic metastasis presenting liver involvement more than 75%
  2. Patients with uncontrolled infections (sepsis)
  3. Evidence of extrahepatic disease, including local lymph node metastasis (except peri-hilar nodes).
  4. History of another malignancy diagnosed within 5 years, excluding "in situ" skin and cervical cancers, without metastases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920503

Locations
Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore Recruiting
Pesaro, Italy, 61122
Contact: Giammaria Fiorentini, MD    +39072136 ext 4124    giammaria.fiorentini@ospedalimarchenord.it   
Principal Investigator: Giammaria Fiorentini, MD         
Sponsors and Collaborators
International Group of Endovascular Oncology
  More Information

Additional Information:
Publications:
Responsible Party: International Group of Endovascular Oncology
ClinicalTrials.gov Identifier: NCT01920503     History of Changes
Other Study ID Numbers: CHOLANGIO01, CHOLANGIO100513
Study First Received: August 7, 2013
Last Updated: August 10, 2013
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by International Group of Endovascular Oncology:
cholangiocarcinoma
transarterial chemoembolization
doxorubicin
tumor response

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014