Clinical trial NCT05551299: Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy
Official title: Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hilar Cholangiocarcinoma
Keywords: Hilar Cholangiocarcinoma
Radiofrequency ablation (RFA)
Photodynamic therapy (PDT)
Photosensitizer
Klatskin Tumor
Bile Duct Cancer
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Zentrum für Klinische Studien Leipzig
First posted: 2022-09-22
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bile duct cancer is often diagnosed after curative options are no longer available. Stent therapy is used to keep the ducts open and can be combined with photodynamic therapy (PDT) to extend life expectancy. PDT requires an injection of photosensitizer after which light of a particular wavelength is applied endoscopically to kill the cancer cells. Drawbacks include not only high costs and poor availability, but foremost that patients have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA) together with stent implantation constitutes an alternative by which the cancer cells are killed through heat, also applied endoscopically. The RFA technology is more widely available and easier to deploy. However, it has not been studied extensively and no randomized trials exist comparing the two methods. This trial will compare survival in patients with a particular bile duct cancer depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.

Detailed description: Klatskin tumours are a form of bile duct cancer. They are generally not diagnosed until quite late and a curative operation is rarely a possibility. Their anatomic location usually results in bile duct obstruction and the aim of therapy is thus to keep the ducts open. This is accomplished through endoscopic retrograde cholangiopancreatography (ERCP) by implanting stents. Stent therapy combined with photodynamic therapy (PDT) extends life expectancy. PDT requires an injection of photosensitizer that is absorbed primarily by the cancer cells. Light of a particular wavelength is then applied with ERCP to kill the cancer cells. Drawbacks include not only high costs and poor availability, but foremost that patients have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA) together with stent implantation constitutes an alternative by which the cancer cells are killed through heat applied during ERCP. The RFA technology is more widely available and easier to deploy. However, it has not been studied extensively and no randomized trials exist comparing the two methods. This trial will compare survival in patients with Klatskin tumours depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.

Eligibility criteria: Inclusion Criteria:

1. Hilar cholangiocarcinoma (cytological or histological confirmation)
2. Surgery is not planned
3. Age ≥ 18 years
4. Written informed consent

Exclusion Criteria:

1. Tumour not accessible endoscopically
2. Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
3. Leukopenia (\< 2000/mm3)
4. Thrombocytopenia (\< 100,000 / mm³)
5. Severe, uncorrected coagulopathy (at the discretion of the physician)
6. Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists
7. Porphyria (clinician's assessment) or other light-exacerbated diseases
8. Severely impaired liver and or kidney function (at the discretion of the physician)
9. Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3)
10. Planned surgical procedure within the next 30 days
11. Concurrent eye disease that will require a slit lamp examination within the next 30 days
12. Prior radiotherapy within the last four weeks
13. Previous PDT or RFA
14. Planned liver transplantation
15. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial medication on contraception)
16. Participation in other interventional trials
17. Patients under legal supervision or guardianship
18. Pregnant or nursing women

Primary outcomes:
measure: Overall survival
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Overall survival (complementary perspective: median survival time)
timeFrame: through study completion, an average of 1 year
measure: Overall survival (complementary perspective: two-year overall survival)
timeFrame: up to two years
measure: Overall survival (complementary perspective: restricted mean survival on a time horizon of two-years)
timeFrame: through study completion, an average of 1 year
measure: Days alive and out of hospital up to two years
timeFrame: up to two years
measure: Quality of Life (QoL) measured using QLQ-C30 at various points in time after randomization (V2 (14 days), V3 (ca. 3 months), as a function of time after 6 months, adjusting for the baseline value)
timeFrame: through study completion, an average of 1 year
measure: Quality of Life (QoL) measured using FACT-Hep at various points in time after randomization (V2 (14 days), V3 (ca. 3 months), as a function of time after 6 months, adjusting for the baseline value)
timeFrame: through study completion, an average of 1 year
measure: Quality-adjusted life years (QALYs)
timeFrame: through study completion, an average of 1 year
measure: Stent patency based on clinician's assessment (e.g. cholangitis, cholestasis, ultrasound)
timeFrame: through study completion, an average of 1 year
measure: Laboratory parameter (leucocytes)
timeFrame: through study completion, an average of 1 year
measure: Laboratory parameter (haematocrit)
timeFrame: through study completion, an average of 1 year
measure: Laboratory parameter (haemoglobin)
timeFrame: through study completion, an average of 1 year
measure: Laboratory parameter (bilirubin)
timeFrame: through study completion, an average of 1 year
measure: Laboratory parameter (albumin)
timeFrame: through study completion, an average of 1 year
measure: Laboratory parameter (CA 19-9)
timeFrame: through study completion, an average of 1 year
measure: Laboratory parameter (CRP)
timeFrame: through study completion, an average of 1 year
measure: Laboratory parameter (ALT)
timeFrame: through study completion, an average of 1 year
measure: Laboratory parameter (GGT)
timeFrame: through study completion, an average of 1 year
measure: Pruritus as reported by patients on a scale from 0 ("no itching") to 10 ("worst imaginable itching").
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen, Medizinische Klinik III
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg; III. Med. Klinik
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenterologie
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt, Medizinische Klinik 1
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald Klinik für Innere Medizin A
city: Halle
country: Germany
facility: Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
city: Hanau
country: Germany
facility: Klinikum Hanau; Klinik für Gastroenterologie, Diabetologie und Infektiologie
city: Hannover
country: Germany
facility: KRH Klinikum Siloah, Klinik für Gastroenterologie
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH; Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endokrinologie
city: Leipzig
country: Germany
facility: University Hospital of Leipzig, Department of Gastroenterology
city: Ludwigsburg
country: Germany
facility: RKH Kliniken Ludwigsburg- Bietigheim gGmbH, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim, II. Medizinische Klinik
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH (UKGM); Klinik für Innere Medizin mit den Schwerpunkten Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie
city: München
country: Germany
facility: Klinikum der LMU München, Medizinische Klinik II, Campus Großhadern
city: Münster
country: Germany
facility: Universitlitsklinikum Munster Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische lnfektiologie)
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord; Gastroenterologie/ Endokrinologie
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus (RBK) Stuttgart; Gastroenterologie, Hepatologie und Endokrinologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Medizinische Klinik I
Study officials:
affiliation: Universitätsklinikum Leipzig; Bereich Gastroenterologie
name: Albrecht Hoffmeister, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: