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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00469417
First received: May 3, 2007
Last updated: September 1, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Superficial Basal Cell Carcinoma
 Procedure: Cryotherapy or Photodynamic therapy with methyl aminolevulinate cream
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Galderma:

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 [ Time Frame: 3 months after treatment ]

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. [ Time Frame: Up to 60 months after treatment ]

Enrollment: 120
Study Start Date: October 1999
Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469417

Locations
Austria
University of Graz
Graz, Austria, 8036
Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, B3000
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
France
Hôpital Sainte-Marguerite
Marseille, France, 13277
Service de Dermatologie, C.H.U Saint Louis
Paris, France, 754747
Italy
Spedali di Brescia
Brescia, Italy, 25125
Sweden
Länsjukhuset Ryhov
Jönköping, Sweden, 55185
Universitetssjukhuset
Linköping, Sweden, 58185
Huddinge Sjukhus
Stockholm, Sweden, 14186
Regionsjukhuset i Örebro
Örebro, Sweden, 70185
United Kingdom
University of Wales
Cardiff, United Kingdom, CF4 4XN
Ninewells Hospital
Dundee, United Kingdom, DDI 954
Falkirk and District Royal Infirmary
Falkirk, United Kingdom, F1 5QE
Glasgow University Hospital
Glasgow, United Kingdom, GI2 8QQ
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Nicole Basset-Séguin, Professor Saint-Louis Hospital, Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00469417     History of Changes
Other Study ID Numbers: PC T304/99
Study First Received: May 3, 2007
Last Updated: September 1, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency
Austria: Agency for Health and Food Safety
Finland: Finnish Medicines Agency

Keywords provided by Galderma:
Methyl aminolevulinate
Photodynamic therapy
Primary Superficial Basal Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Aminolevulinic Acid
 Methyl 5-aminolevulinate
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013