To assess efficacy and safety of temoporfin (Foscan*) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of local response and depth of tumoricidal tissue penetration of Foscan*-
PDT.
Secondary outcome
(i) Progression-free survival time, overall survival time; (ii) rate of
systemic response; (iii) Toxicity using WHO criteria and criteria for local
toxicity in the biliary system.
Background summary
Photodynamic therapy (PDT) can be defined as photochemotherapy. A
photosensitizing drug known to accumulate in tumor tissue is administered.
Subsequently, the tumor tissue is exposed to laser light of appropriate wave
length suitable to activate the photosensitizing drug. In presence of oxygen
the activated photosensitizer leads to phototoxic reactions in the tumor
tissue. Two prospective, single-arm, open phase II trials on 9 and 23 patients,
respectively, with non-resectable proximal bile duct cancer (29 Bismuth type
IV, 3 type III) showed significantly improved palliation (cholestasis,
performance status, quality of life indices) and a clear trend for prolonged
survival (median 12 - 14 months, respectively) with PDT using the
hematoporphyrin derivative, sodium porfimer (Photofrin*). Prolonged survival
time with PDT using Photofrin* as compared with biliary drainage only was
confirmed in a randomized trial. Tumoricidal tissue penetration is limited to
4-5 mm with Photofrin*. PDT using temoporfin (Foscan*, Biolitec Pharma,
Edinburgh, UK) shows deeper tumoricidal tissue penetration of > 8mm and high
tumor selectivity and has been validated for PDT of oropharyngeal cancers and
been licensed for that indication in the EU.
Study objective
To assess efficacy and safety of temoporfin (Foscan*) photodynamic therapy in
the treatment of locally advanced perihilar bile duct carcinoma without distant
metastases.
Study design
Open-label Phase-II trial of Foscan* (temoporfin) photodynamic therapy in
patients with non-resectable perihilar bile duct carcinoma in clinical stage M0
(without liver or peritoneal metastases according to clinical or surgical
staging)
Intervention
Open-label Phase-II trial of Foscan* (temoporfin) photodynamic therapy in
patients with non-resectable perihilar bile duct carcinoma in clinical stage M0
(without liver or peritoneal metastases according to clinical or surgical
staging)
Study burden and risks
The burden associated with participation in this study is expected to be
confined to the few more days of hospitalisation after the endoscopic procedure
during which PDT is performed, and the potential pain caused by the PDT. This
extra burden is contrasted with the potentially improved palliation and
prolonged survival, which was shown in earlier studies. For patients without
the possibility of a curative surgical resection, a group which is
characterized by a very poor prognosis, more evidence for the efficacy and
safety of Foscan-PDT would provide the rationale and possiblity to offer these
patients a new therapeutic modality to alleviate their suffering.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
* bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:
a) Bismuth type III or IV ( not resectable with R0-margins )
b) 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 for PDT (Appendix 3)
Exclusion criteria
* 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 (or unsafe 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)
* acute destructive bacterial cholangitis (empyema, abscess, cholangitis with confluent liver necrosis)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-004866-17-NL |
| CCMO | NL31169.018.10 |