CholangiocarcinomaCHOLANGIONCT01920503
International Registry on Cholangiocarcinoma Treatment
An observational study of Cholangiocarcinoma, run by International Group of Endovascular Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Doxorubicin
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2013to Aug 2020
- How long will I take part?
- 12 Months
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore
Pesaro, 61122
Giammaria Fiorentini, MD, +39072136 ext. 4124, giammaria.fiorentini@ospedalimarchenord.it
Giammaria Fiorentini, MD
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Cholangiocarcinoma
- Being tested
- Doxorubicin
- Keywords
- cholangiocarcinoma, transarterial chemoembolization, doxorubicin, tumor response
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Also called Adriamycin
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response
CT scan evaluated with RECIST 1.1
Measured: 12 months
overall survival
survival from start of treatment
Measured: 12 months
Secondary outcomes (1)
number adverse events
number of adverse events observed for each patient
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- International Group of Endovascular Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giammaria Fiorentini, MD, Principal investigator, International Group of Endovascular Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920503
- Sponsor's protocol ID
- CHOLANGIO01
- Other IDs
- CHOLANGIO100513
- Acronym
- CHOLANGIO
- Status last verified
- Feb 2019
- First submitted
- 7 Aug 2013
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18478290Cantore 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.
PubMed 16767908Fiorentini 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.
PubMed 30191053
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry on Cholangiocarcinoma Treatment
- ClinicalTrials.gov ID
- NCT01920503
- Acronym / sponsor ID
- CHOLANGIO / CHOLANGIO01
- Conditions
- Cholangiocarcinoma
- Keywords
- cholangiocarcinoma, transarterial chemoembolization, doxorubicin, tumor response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- International Group of Endovascular OncologyUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| doxorubicin | – | Drug: DoxorubicinDay +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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxorubicinAlso: AdriamycinDoxorubicina 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 | Drug | doxorubicin |
Primary outcome
tumor response
Time frame: 12 months
CT scan evaluated with RECIST 1.1
overall survival
Time frame: 12 months
survival from start of treatment
1 secondary outcome
number adverse events
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Results publication: PubMed 18478290Aliberti 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.
- Results publication: PubMed 16767908Cantore 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.
- Derived from this study: PubMed 30191053Fiorentini 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.
- International group of endovascular oncology (IGEVO) websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giammaria Fiorentini, MD principal investigator
International Group of Endovascular Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma, run by International Group of Endovascular Oncology 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 7 inclusion and 4 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 27 Feb 2019. 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 Giammaria Fiorentini (+390721364005, giammaria.fiorentini@ospedalimarchenord.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response (time frame: 12 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 NCT01920503, which also lists 3 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 27 Feb 2019.