CompletedPhase 2

Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)

France55 participantsStarted 2014-11-18

Plain-language summary

Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with locally advanced BCC.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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).
✓. Written informed consent
✓. Age ≥ 18 years old
✓. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
✓. At least one histologically confirmed lesion...
✓. Patients with Gorlin syndrome may enroll in this study but must meet the other inclusion criteria
✓. Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1)

✕. Inability or unwillingness to swallow capsules
✕. Patients with BCC situated out of the head or the neck area
✕. Pregnancy or lactation
✕. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy or photodynamic therapy
✕. Chemotherapy within 4 weeks prior to enrollment
✕. Participation in another clinical trial within 4 weeks prior to enrollment
✕. Radiotherapy within 6 months prior to enrolment
✕. Metastatic BCC

the change in surgery stages

Timeframe: Between baseline and maximum 10 months of treatment

NCT IDNCT02667574

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-15

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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).
✓. Written informed consent
✓. Age ≥ 18 years old
✓. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
✓. At least one histologically confirmed lesion...
✓. Patients with Gorlin syndrome may enroll in this study but must meet the other inclusion criteria
✓. Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1)

✕. Inability or unwillingness to swallow capsules
✕. Patients with BCC situated out of the head or the neck area
✕. Pregnancy or lactation
✕. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy or photodynamic therapy
✕. Chemotherapy within 4 weeks prior to enrollment
✕. Participation in another clinical trial within 4 weeks prior to enrollment
✕. Radiotherapy within 6 months prior to enrolment
✕. Metastatic BCC