E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Basal cell carcinoma of the skin |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004146 |
E.1.2 | Term | Basal cell carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004148 |
E.1.2 | Term | Basal cell carcinoma excision |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004149 |
E.1.2 | Term | Basal cell carcinoma skin excision |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024542 |
E.1.2 | Term | Lip basal cell carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027492 |
E.1.2 | Term | Metatypical basal cell carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027981 |
E.1.2 | Term | Morpheaform basal cell carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029496 |
E.1.2 | Term | Nodulo-ulcerative basal cell carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035029 |
E.1.2 | Term | Pigmented basal cell carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039716 |
E.1.2 | Term | Sclerosing basal cell carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042503 |
E.1.2 | Term | Superficial basal cell carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062787 |
E.1.2 | Term | Morphoeaform basal cell carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064679 |
E.1.2 | Term | Basal cell carcinoma of skin in situ |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10004146 |
E.1.2 | Term | Basal cell carcinoma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of this clinical study is to compare results of treatment of Basal Cell Carcinoma using electrochemotherapy and conventional surgical excision. The surgery has to be carried out in a theatre under general anaesthesia. It involves not only surgeon but also anaesthetist and theatre personnel. It is time consuming. Electrochemotherapy is carried out in a procedure room, usually under sedation and local anaesthesia. It involves a surgeon and a single nurse. The whole procedure takes in average 20min. It is less invasive and carries minor risk of local complications.
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E.2.2 | Secondary objectives of the trial |
We plan to compare: - outcome of treatment - recurrence rate - cosmetic effect - total cost - duration of procedure - patients’ distress - patients’ satisfaction
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients with diagnosed Basal Cell Carcinoma • Age ≥18 years old • Performance status: Karnofsky ≥70%; WHO ≤2 • Patients mentally capable of understanding the information given • Life expectancy >5 years • Informed consent form signed
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E.4 | Principal exclusion criteria |
• Previously treated lesions (Radiotherapy or otherwise) • Lesions spread to other sites, including lymph nodes • Advanced BCC where there is a question of invasion or involvement of tissue other than skin and subcutaneous tissue (bone, cartilage) • Squamous Cell Carcinoma • Presence of second primary cancer • Allergy to bleomycin • Chronic renal dysfunction • Acute pulmonary infection • Reduced lung function • Coagulopathy • Epilepsy • Clinically manifested arrhythmia or with pacemaker • Pregnancy or lactation • Intention to conceive a child within 12 months after the treatment (both men and women)
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E.5 End points |
E.5.1 | Primary end point(s) |
Aim is to treat a group of 50 patients with electrochemotherapy and 50 patients with conventional surgery. Patients are assigned to the groups in a random manner. The study should end in June 2011. That will be followed by systematic reviews of patients post treatment for a period of 5 years. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
conventional surgical excision |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial can be defined as the treatment of 50 patients in each group and their individual 5 year subsequent follow up. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |