NCT01482104

Brief Summary

Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week apart. This procedure is considered quite time- and resource-consuming. Introducing a single treatment session, with a new PDT session for treatment failures after 3 months, might represent an attractive simplification. This randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments 1 week apart. Secondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
277

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

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

First Submitted

Initial submission to the registry

November 17, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

5.3 years

First QC Date

November 17, 2011

Last Update Submit

October 26, 2017

Conditions

Skin NeoplasmsCarcinoma, Basal Cell

Keywords

Photochemotherapymethyl 5-aminolevulinate

Outcome Measures

Primary Outcomes (1)

  • lesions response rate

    Number of lesions in clinical complete response at follow-up

    3 years

Study Arms (2)

MAL-PDT re-treatment

EXPERIMENTAL

1 treatment of MAL-PDT with re-treatment of non-complete responders

Drug: MAL-PDT re-treatment

usual MAL-PDT

ACTIVE COMPARATOR

2 MAL-PDT treatments 1 week apart

Drug: usual MAL-PDT

Interventions

MAL-PDT re-treatmentDRUG

a schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months

Also known as: Methyl-aminolevulinate
MAL-PDT re-treatment
usual MAL-PDTDRUG

schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.

Also known as: Methyl-aminolevulinate
usual MAL-PDT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male/female above 18 years of age
  • written informed consent
  • or more primary histologically verified BCC, clinically assessed as of either superficial of nodular type

You may not qualify if:

  • pregnancy
  • breastfeeding
  • Gorlin's syndrome
  • porphyria
  • xeroderma pigmentosum
  • history of arsenic exposure
  • known allergy to MAL
  • concomitant treatment with immunosuppressive medication
  • physical or mental conditions that most likely will prevent patients attending follow-up sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Dept Dermatology, Haukeland University Hospital

Bergen, Norway

Location

Central Hospital Førde

Førde, Norway

Location

Hudlegekontoret Lillehammer AS

Lillehammer, Norway

Location

Akerskus Dermatological Centre

Lørenskog, Norway

Location

Dept Dermatology, Oslo University Hospital

Oslo, Norway

Location

Dept Surgery, Oslo University Hospital

Oslo, Norway

Location

Hudlegen på Holtet

Oslo, Norway

Location

Dept Dermato-Venereology, Stavanger University Hospital

Stavanger, Norway

Location

Department of Cancer Research and Molecular Medicine, NTNU

Trondheim, Norway

Location

MeSH Terms

Conditions

Skin NeoplasmsCarcinoma, Basal Cell

Interventions

methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Basal Cell

Study Officials

  • Magne Børset, PhD prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2011

First Posted

November 30, 2011

Study Start

June 1, 2012

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations

NO(9)