E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Histologically proven primary nodular basal cell carcinoma ≥ 4mm and ≤ 20mm in diameter outside the face and hairy scalp. |
Histologisch bevestigd primair nodulair basaalcelcarcinoom ≥ 4mm < 20mm in diameter buiten het gelaat en de behaarde hoofdhuid. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10073093 |
E.1.2 | Term | Nodular basal cell carcinoma |
E.1.2 | System Organ Class | 100000004864 |
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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 |
To compare long-term efficacy of curettage prior to IMQ 5% cream (Aldara®) therapy versus standard surgical excision in primary nodular basal cell carcinoma.
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Het vergelijken van lange termijn effectiviteit van imiquimod 5% crème (Aldara), met voorafgaand curettage versus standaard chirurgische excisie bij primaire nodulaire basaalcelcarcinomen.
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E.2.2 | Secondary objectives of the trial |
To assess compliance, cosmetic outcomes, patient satisfaction, patient preference and cost-effectiveness. |
Het bepalen van compliance, cosmetiek, patienttevredenheid, patientvoorkeur en kosten-effectiviteit. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adults aged 18 years or older - Primary histologically proven nodular basal cell carcinoma ≥ 4mm and ≤ 20mm in diameter - Patient is able to apply cream - Comorbidities may not interfere with study treatment (evaluated by investigator) - Capable to understand instructions |
- Volwassenen ouder dan 18 jaar - Primair histologisch bevestigd nodulair basaalcelcarcinoom ≥ 4mm en ≤ 20mm in diameter - Patient is in staat om creme aan te brengen - Comorbiditeiten mogen niet met studiemedicatie interfereren (geevalueerd door onderzoeker) - In staat instructies te begrijpen |
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E.4 | Principal exclusion criteria |
- A nodular BCC located in the face or hairy scalp - Recurrent (previously treated) nBCC - Aggressive histopathologcial BCC subtypes - Life expectancy of less than five years - Breast-feeding or pregnant women - Serious comorbidities (evaluated by investigator) - Use of immunosuppressive medication during the trial period until 3 months after end of treatment or within 30 days before enrolment - Patients with genetic skin cancer disorders |
- Een nodulair BCC gelokaliseerd in het gezicht of de behaarde hoofdhuid - Recidief nodulair BCC (eerdere behandeling) - Agressieve histopathologische BCC subtypes - Levensverwachting van korter dan vijf jaar - Vrouwen die borstvoeding geven of zwanger zijn - Ernstige comorbiditeiten - Gebruik van immunosuppressive middelen tijdens de studie periode tot 3 maanden na het einde van de behandeling of 30 dagen voor start van de studie - Patiënten met genetische huidmaligniteiten syndromen |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion free of initial nBCC patients at one 1 year after end of treatment (defined as absence of initial treatment failure or any clinical signs of local recurrence). |
Proportie tumorvrije (initieel nBCC) patienten 1 jaar na het einde van de behandeling (gedefinieerd als afwezigheid van initieel behandelfalen of klinische tekenen van locaal recidief). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 1 year after end of treatment |
Op 1 jaar na het einde van de behandeling |
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E.5.2 | Secondary end point(s) |
5-year cumulative probability of recurrence free survival after end of treatment, compliance, pain, cosmetic appearance, patient satisfaction, patient preference and cost-effectiveness. |
5-jaar cumulatieve waarschijnlijkheid van recidief vrije survival na het einde van de behandeling, compliance, pijn, cosmetisch resultaat, patienttevredenheid, patient voorkeur en kosten-effectiviteit. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
5-year cumulative probability of recurrence free of initial BCC survival after end of treatment.
Compliance in imiquimod group at week 6 in patient diary.
Pain during treatment and two weeks after end of treatment.
Cosmetic appearance and patient satisfaction after 1 and 5 years after end of treatment.
Patient preference at start of treatment.
Cost-effectiveness after 1 and 5 year follow-up.
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5-jaar cumulatieve waarschijnlijkheid van recidief vrije survival van het initiële BCC na het einde van de behandeling.
Compliance in imiquimod groep in week 6 uit patiëntdagboekjes.
Pijn tijdens de behandeling en twee weken na afloop van de behandeling.
Cosmetisch resultaat en patienttevredenheid na 1 en 5 jaar na beëindiging van de behandeling.
Patientvoorkeur aan het begin van de behandeling.
Kosteneffectiviteit na 5 jaar follow-up. |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Niet-inferioriteit |
Non-inferiority |
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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 |
Standaard chirurgische excisie met 3-5 mm marge |
Standard surgical excision with 3-5 mm margin |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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 will be the last visit of the last subject undergoing the trial. |
Het einde van de studie is als het laatste bezoek van de laatste proefpersoon die meedoet aan de studie heeft plaatsgevonden. |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |