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Drug shrinks skin cancer before surgery, may reduce cutting

NCT ID NCT02667574

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

55 people

The number who actually took part.

Started

Nov 2014

Finished

Jul 2020

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • CH de Boulogne sur mer

    Boulogne-sur-Mer, Boulogne Sur Mer, 62321, France

  • CHU - Hôpital d'Estaing

    Clermont-Ferrand, Clermont-Ferrand, 63003, France

  • CHU Ambroise Paré

    Paris, Paris, 92104, France

  • CHU Bocage

    Dijon, Dijon, 21079, France

  • CHU de Besançon

    Besançon, Besançon, 25030, France

  • Centre hospitalier Lyon Sud

    Pierre-Bénite, Pierre-benite, 69495, France

  • Clinique de Dermatologie

    Lille, Lille, 59037, France

  • Hôpital Bichat

    Paris, PARIS, 75018, France

  • Hôpital Haut-Lévêque

    Pessac, Pessac, 33604, France

  • Hôpital Pontchaillou

    Rennes, Rennes, 35033, France

  • Hôpital Robert Debré

    Reims, Reims, 51100, France

  • Hôpital Saint Eloi

    Montpellier, Montpellier, 34295, France

  • Hôpital Saint-Louis

    Paris, PARIS, 75475, France

  • Hôpital St André

    Bordeaux, Bordeaux, 33075, France

  • Hôpital de la Timone

    Marseille, Marseille, 13885, France

  • Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy, 54500, France

  • Institut Gustave Roussy

    Villejuif, Villejuif, 94805, France

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