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Metvix PDT Versus Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma

Primary Purpose

Superficial Basal Cell Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cryotherapy or Photodynamic therapy with methyl aminolevulinate cream
Sponsored by
Galderma R&D
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Superficial Basal Cell Carcinoma focused on measuring Methyl aminolevulinate, Photodynamic therapy, Primary Superficial Basal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A patient with superficial BCC lesion(s) suitable for entry was defined as a patient with:

  • histologically confirmed diagnosis of primary superficial BCC lesion(s)
  • BCC lesions suitable for cryotherapy
  • males or females above 18 years of age
  • written informed consent. In accordance with Amendment 2 (local amendment), only patients above 19 years of age were to be included in Austria.

Exclusion Criteria:

A patient or lesion fulfilling any of the following criteria was ineligible for inclusion:

  • prior treatment of the BCC lesion(s)
  • patients with more than 10 eligible BCC lesions
  • a superficial BCC lesion with the largest diameter exceeding 15 mm on face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on the trunk
  • a superficial BCC lesion with the largest diameter smaller than 6 mm
  • patient with porphyria
  • patient with Gorlin's syndrome
  • pigmented superficial BCC lesion(s)
  • morpheaform lesion(s)
  • infiltrating lesion(s)
  • patients with a history of arsenic exposure
  • known allergy to Metvix®, a similar PDT compound or excipients of the cream
  • participation in other clinical studies either concurrently or within the last 30 days
  • pregnant or breast-feeding; all women of child-bearing potential had to document a negative pregnancy test and use the pill or intrauterine device during the treatments and for at least one month thereafter
  • conditions associated with a risk of poor protocol compliance.

In Amendment 1 the following exclusion criteria were added:

  • xeroderma pigmentosum lesion
  • concurrent use of immunosuppressive medication.

Sites / Locations

  • University of Graz
  • Universitaire Ziekenhuizen Leuven
  • Helsinki University Central Hospital
  • Hôpital Sainte-Marguerite
  • Service de Dermatologie, C.H.U Saint Louis
  • Spedali di Brescia
  • Länsjukhuset Ryhov
  • Universitetssjukhuset
  • Huddinge Sjukhus
  • Regionsjukhuset i Örebro
  • University of Wales
  • Ninewells Hospital
  • Falkirk and District Royal Infirmary
  • Glasgow University Hospital

Outcomes

Primary Outcome Measures

The primary end-point will be the number of patients in whom 75% or more of the BCC lesions have responded completely at 3 months after PDT with Metvix or 3 months after cryotherapy

Secondary Outcome Measures

Secondary end-points: proportion of patients with less than 75% lesion complete response, number of lesions that show complete response, cosmetic outcome and adverse events. In addition 12, 24, 36, 48 and 60 months recurrence rates will be assessed.

Full Information

First Posted
May 3, 2007
Last Updated
September 1, 2010
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT00469417
Brief Title
Metvix PDT Versus Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma
Official Title
A Multicenter, Phase III, Randomised Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Comparison With Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Galderma R&D

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of patients with primary superficial basal cell carcinoma. Secondary objectives are to compare cosmetic outcome and tolerability (adverse events) in these patients, 3 months after treatment. In addition the recurrence rates in the two treatment groups will be compared up to five years after treatment.
Detailed Description
BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common malignant tumour of any organ, mostly affecting head and neck (84%) in fair-skinned people. Several non-pharmacological treatment modalities are used for BCC, including excision surgery, Moh's surgery, radiation, curettage/electrodesiccation and cryotherapy. The treatment used depends on the type, size, depth and localisation of the BCC lesion. The use of PDT is attractive for the treatment of BCCs because of its efficiency, mild and local side effects and excellent cosmetic outcome. Previous clinical experience is promising and patients with primary BCCs will be included in this prospective, randomised, comparative, multicenter study to show that Metvix is non-inferior to alternative treatment with better cosmetic outcome. The primary end-point will be the number of patients in whom 75% or more of the BCC lesions have responded completely at 3 months after PDT with Metvix or 3 months after cryotherapy. Both on-site and independent, blinded response assessments will be analysed. The analysis based on the results of the independent review board constitutes the primary analysis. The secondary end-points will be the proportion of patients in whom less than 75% of the BCC lesions respond completely, number of lesions across patients that show complete response, evaluation of cosmetic outcome and adverse events 3 months after Metvix PDT or 3 months after cryotherapy. In addition 12, 24, 36, 48 and 60 months recurrence rates will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Basal Cell Carcinoma
Keywords
Methyl aminolevulinate, Photodynamic therapy, Primary Superficial Basal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Cryotherapy or Photodynamic therapy with methyl aminolevulinate cream
Primary Outcome Measure Information:
Title
The primary end-point will be the number of patients in whom 75% or more of the BCC lesions have responded completely at 3 months after PDT with Metvix or 3 months after cryotherapy
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Secondary end-points: proportion of patients with less than 75% lesion complete response, number of lesions that show complete response, cosmetic outcome and adverse events. In addition 12, 24, 36, 48 and 60 months recurrence rates will be assessed.
Time Frame
Up to 60 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A patient with superficial BCC lesion(s) suitable for entry was defined as a patient with: histologically confirmed diagnosis of primary superficial BCC lesion(s) BCC lesions suitable for cryotherapy males or females above 18 years of age written informed consent. In accordance with Amendment 2 (local amendment), only patients above 19 years of age were to be included in Austria. Exclusion Criteria: A patient or lesion fulfilling any of the following criteria was ineligible for inclusion: prior treatment of the BCC lesion(s) patients with more than 10 eligible BCC lesions a superficial BCC lesion with the largest diameter exceeding 15 mm on face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on the trunk a superficial BCC lesion with the largest diameter smaller than 6 mm patient with porphyria patient with Gorlin's syndrome pigmented superficial BCC lesion(s) morpheaform lesion(s) infiltrating lesion(s) patients with a history of arsenic exposure known allergy to Metvix®, a similar PDT compound or excipients of the cream participation in other clinical studies either concurrently or within the last 30 days pregnant or breast-feeding; all women of child-bearing potential had to document a negative pregnancy test and use the pill or intrauterine device during the treatments and for at least one month thereafter conditions associated with a risk of poor protocol compliance. In Amendment 1 the following exclusion criteria were added: xeroderma pigmentosum lesion concurrent use of immunosuppressive medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Basset-Séguin, Professor
Organizational Affiliation
Saint-Louis Hospital, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
B3000
Country
Belgium
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Hôpital Sainte-Marguerite
City
Marseille
ZIP/Postal Code
13277
Country
France
Facility Name
Service de Dermatologie, C.H.U Saint Louis
City
Paris
ZIP/Postal Code
754747
Country
France
Facility Name
Spedali di Brescia
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Facility Name
Länsjukhuset Ryhov
City
Jönköping
ZIP/Postal Code
55185
Country
Sweden
Facility Name
Universitetssjukhuset
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Huddinge Sjukhus
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Regionsjukhuset i Örebro
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
University of Wales
City
Cardiff
ZIP/Postal Code
CF4 4XN
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DDI 954
Country
United Kingdom
Facility Name
Falkirk and District Royal Infirmary
City
Falkirk
ZIP/Postal Code
F1 5QE
Country
United Kingdom
Facility Name
Glasgow University Hospital
City
Glasgow
ZIP/Postal Code
GI2 8QQ
Country
United Kingdom

12. IPD Sharing Statement

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Metvix PDT Versus Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma

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