NCT01016002

Brief Summary

The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

November 18, 2009

Status Verified

November 1, 2009

Enrollment Period

5.9 years

First QC Date

November 16, 2009

Last Update Submit

November 16, 2009

Conditions

Non-curative Resectable Bile Duct Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT

    post treatment

Secondary Outcomes (2)

  • Progression-free survival time, overall survival time

    Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention

  • Toxicity using WHO criteria and criteria for local toxicity in the biliary system

    Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention

Study Arms (1)

Intervention

EXPERIMENTAL
Drug: Temoporfin

Interventions

TemoporfinDRUG

Drug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min. Laser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan

Also known as: Foscan, Meso-tetrahydroxyphenyl Chlorin
Intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:
  • Bismuth type III or IV ( not resectable with R0-margins )
  • Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient
  • sufficient general condition to undergo PDT (Karnofsky status \> 30%)
  • age \> 19 years
  • access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
  • informed written consent

You may not qualify if:

  • porphyria or other diseases exacerbated by light
  • known intolerance or allergies to porphyrin derivatives
  • a planned surgical procedure within the next 30 days
  • coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days
  • impaired kidney or liver function (creatinine \> 2.5x elevated, INR \> 2.2 on vitamin K),
  • leukopenia ( WBC \< 2000/cmm ) or thrombopenia ( \< 50000/cmm ),
  • cytotoxic chemotherapy within the past 4 weeks.
  • pregnancy ( and safe contraception for 6 months after PDT )
  • accompanying/complicating disease with very poor prognosis (expected survival \< 6 weeks),
  • proven advanced peritoneal carcinomatosis ( PET scan imaging, ascites positive for tumor cells)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Internal Medicine I, Paracelsus Medical University Salzburg

Salzburg, Salzburg, 5020, Austria

RECRUITING

Internal Medicine Dept., University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Interventions

temoporfin

Study Officials

  • Frieder Berr, Prof., MD

    Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria

    PRINCIPAL INVESTIGATOR

  • Lohse A, Prof., MD

    University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frieder Berr, Prof., MD

CONTACT

(43-) 662-4482f.berr@salk.at

Lohse A, Prof., MD

CONTACT

+49-(0)40-4280alohse@uke-uni-hamburg.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 18, 2009

Study Start

January 1, 2006

Primary Completion

December 1, 2011

Last Updated

November 18, 2009

Record last verified: 2009-11

Locations

DE(1)AU(1)