Drug shrinks skin cancer before surgery, may reduce cutting
NCT ID NCT02667574
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the drug vismodegib given before surgery to people with advanced basal cell carcinoma (a type of skin cancer). The goal was to see if the drug could shrink the tumor enough to allow for a smaller, less invasive surgery. 55 participants took the drug for a period before their planned operation. The study measured how much the required surgery changed compared to what was originally planned.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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55 people
The number who actually took part.
- Started
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Nov 2014
- Finished
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Jul 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with BCC, which surgery stage is A, B or C (cf. Appendix 3: Definition of surgery stages), with a diameter ≥ 3cm in zones at intermediate risk of tumor recurrence and a BCC with a diameter of ≥ 2 cm in the zones at higher risk of tumor recurrence. According to the HAS recommendations, two zones are taken into consideration: * Zones at intermediate risk of tumor recurrence: forehead, cheek, chin, neck and scalp * Zones at higher risk of tumor recurrence: nose and periorificial sites of the cephalic extremity 2. The decision to include the patient in this study should be taken during the Pluridisciplinary Committee Meeting (RCP). During this RCP, the radiotherapy should be considered as an inadequate treatment. (If the radiotherapist is absent during the meeting, his opinion should be documented in the patient's medical record). 3. Written informed consent 4. Age ≥ 18 years old 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2 6. At least one histologically confirmed lesion... 7. Patients with Gorlin syndrome may enroll in this study but must meet the other inclusion criteria 8. Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1) 9. Adequate organ function, as evidenced by the following laboratory results: * Hemoglobin \> 8.5 g/dL * Granulocyte count ≥ 1000/μL * Platelet count ≥ 75,000/μL * Aspartate transaminase (AST ) and alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN) * Total bilirubin ≤ 1.5 × ULN or within 3 × ULN for patients with documented Gilbert syndrome 10. Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year. 11. Women of childbearing potential must use one highly-effective method of contraception and one barrier method of contraception during treatment and for 24 months after the final dose. Highly-effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, or intra-uterine devices; refer to Appendix 8 for more details). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, and postovulation methods\] and withdrawal are not acceptable methods of contraception.). 12. For male patients with female partners of childbearing potential, agreement top use a condom with spermicide, even after vasectomy, during sexual intercourse with partners while being treated with Vismodegib and for two months after completion of study treatment 13. For male patients, agreement not to donate semen during the study and for 24 months after discontinuation of Vismodegib 14. Agreement not to donate blood or blood products during the study and for at least 24 months after discontinuation of Vismodegib. 15. Life expectancy \> 12 weeks 16. Patients covered by a Health Insurance System Exclusion Criteria: 1. Inability or unwillingness to swallow capsules 2. Patients with BCC situated out of the head or the neck area 3. Pregnancy or lactation 4. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy or photodynamic therapy 5. Chemotherapy within 4 weeks prior to enrollment 6. Participation in another clinical trial within 4 weeks prior to enrollment 7. Radiotherapy within 6 months prior to enrolment 8. Metastatic BCC 9. Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics. 10. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk from treatment complications. 11. Patients with a rare hereditary problem of galactose intolerance, primary hypolactasia or glucose-galactose malabsorption (according to the product SmPC). 12. Patients unable or unwilling to comply with the protocol requirements 13. Patients in emergency situations 14. Patients kept in detention
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CH de Boulogne sur mer
Boulogne-sur-Mer, Boulogne Sur Mer, 62321, France
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CHU - Hôpital d'Estaing
Clermont-Ferrand, Clermont-Ferrand, 63003, France
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CHU Ambroise Paré
Paris, Paris, 92104, France
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CHU Bocage
Dijon, Dijon, 21079, France
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CHU de Besançon
Besançon, Besançon, 25030, France
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Centre hospitalier Lyon Sud
Pierre-Bénite, Pierre-benite, 69495, France
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Clinique de Dermatologie
Lille, Lille, 59037, France
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Hôpital Bichat
Paris, PARIS, 75018, France
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Hôpital Haut-Lévêque
Pessac, Pessac, 33604, France
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Hôpital Pontchaillou
Rennes, Rennes, 35033, France
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Hôpital Robert Debré
Reims, Reims, 51100, France
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Hôpital Saint Eloi
Montpellier, Montpellier, 34295, France
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Hôpital Saint-Louis
Paris, PARIS, 75475, France
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Hôpital St André
Bordeaux, Bordeaux, 33075, France
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Hôpital de la Timone
Marseille, Marseille, 13885, France
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Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy, 54500, France
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Institut Gustave Roussy
Villejuif, Villejuif, 94805, France
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