Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Photosensitizing Agents

Topical retinoid and Light therapy with photosensitizing agent

Light therapy with photosensitizing agent

Topical Retinoid - Apply to AKs for 4 weeks Photo-therapy with photosensitizing agent- Apply to AKs at week 4

Topical retinoid and blue-light therapy with photosensitizing agent

Photo-therapy with sensitizing agent - apply to AKs at week 4

Photodynamic Therapy (PDT)

Murad Alam, MD

Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses.

Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy vs photodynamic therapy alone for the treatment of actinic keratoses.

Photo-therapy With a Topical Retinoid Versus Photo-therapy Alone for Actinic Keratoses

A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses

Northwestern University

Associate Professor of Dermatology

Rare Diseases

Cholangiocarcinoma

Klatskin Tumor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one PDT at baseline according to the clinical routine of the trial site.

The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one RFA at baseline according to the clinical routine of the trial site.

A photosensitizer, which is absorbed preferentially by tumour cells, is administered 24 - 48 hours prior to PDT. Light of a particular wavelength is then applied during endoscopic retrograde cholangiopancreatography (ERCP) to kill primarily cancer cells locally within the stenosis. Immediately after PDT treatment, new stents are inserted into all treated segments if needed.

Photosensitizer

RFA is also carried out as part of an ERCP. The RFA-probe is placed within the tumour stenosis and electrical current is applied. New stents are inserted into all treated segments if needed.

Radiofrequency ablation (RFA)

Albrecht Hoffmeister, Prof.Dr.med.

Marcus Hollenbach, Dr. med.

Karim Hamesch, PD Dr.

Tobias Weber, Dr.

Thomas Brunk, Dr.

Dominik Kaczmarek, Dr.

Jörg Trojan, Prof. Dr.

Armin Küllmer, Dr.

Ali Aghdassi, Prof.

Jonas Rosendahl, Prof. Dr.

Likas Welsch, Dr.

Daniel Vidacek, Dr.

Ingolf Schiefke, Prof.

Albrecht Hoffmeister, Prof. Dr.

Andreas Wannhoff, Dr.

Sebastian Belle, PD Dr.

Ulrike Denzer, Prof.

Jörg Schirra, Prof. Dr.

Jonel Trebicka, Prof.

Alexander Dechêne, Prof.

Arthur Schmidt

Christoph Werner, Dr.

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.

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.

Treatment of Non-resectable Bile Duct Cancer With Radiofrequency Ablation or Photodynamic Therapy

Cholangiocarcinoma Treatment With Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial

Hazard ratio from a Cox regression model will be used to compare randomization arms. Covariates will be stratification variables, classification of local inoperability, use of prophylactic antibiotics, Bismuth type and time between diagnosis and beginning RFA/PDT.

Estimates of the difference in median survival time between the groups will be based on the method of Chen and Zhang (PMID: 26983640).

Kaplan-Meier estimates will be used (see e.g. PMID: 15690989)

This constitutes a basic and easy to understand measure of quality of life. Only in-hospital stays will be included in this endpoint and the day of arrival and dismissal will each be counted. The source of data will be the hospital records, epicrisis and patient disclosure.

Prolonging life is especially worthwhile if QoL is sufficiently good. The established cancer-specific Core Quality of Life questionnaire QLQ-C30 from the EORTC (European Organisation for Research will be used. Shortly after the index therapy (V2, V3), the difference between arms will be assessed. The requirement to stay indoors may affect QoL. At later points in time, a description per arm is of interest and will be based on a weighted mean of all available questionnaires, weighting according to calendar time.

Prolonging life is especially worthwhile if QoL is sufficiently good. The Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) questionnaire, containing the hepatobiliary-specific cancer subscale, will be used as a second instrument for assessing QoL. Shortly after the index therapy (V2, V3), the difference between arms will be assessed. The requirement to stay indoors may affect QoL. At later points in time, a description per arm is of interest and will be based on a weighted mean of all available questionnaires, weighting according to calendar time.

Using QALYs, a weighted measure of survival will be compared between RFA and PDT that takes QoL into account. The details will be provided in a Statistical Analysis Plan.

Stent patency provides one measure of the burden of the disease and efficacy of the treatment. Mean time to stent closure/replacement/death after last stent replacement will be analysed.

Changes in laboratory parameters after index treatment (V3) and as a function of time will be analysed and compared between randomization arms.

Pruritus will be analysed as a function of time.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Photo-therapy With a Topical Retinoid Versus Photo-therapy Alone for Actinic Keratoses	NCT00756288	Actinic Keratos...	Topical retinoi... Photodynamic Th...	18 Years - 80 Years	Northwestern University
Treatment of Non-resectable Bile Duct Cancer With Radiofrequency Ablation or Photodynamic Therapy	NCT05551299	Hilar Cholangio...	Photosensitizer Radiofrequency ...	18 Years -	University of Leipzig

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