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Search / Trial NCT05561634

Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Launched by UNIVERSITY HOSPITAL, LILLE · Sep 29, 2022

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Locally Advanced Basal Cell Carcinoma Sonic Hedgehog Inhibitors Consideration Radiotherapy

ClinConnect Summary

This clinical trial is investigating a new approach for treating advanced basal cell carcinoma (BCC), which is a type of skin cancer that can be difficult to manage, especially when it's located in sensitive areas of the body. The study aims to see if combining a treatment called Sonic Hedgehog inhibitors (specifically Vismodegib and Sonidegib) with radiotherapy can help prevent the cancer from coming back after patients have initially responded well to the medication. Researchers believe that this combination might lead to better outcomes for patients who have already achieved a complete response to the inhibitors.

To participate in this trial, individuals must be over 18 years old and have locally advanced BCC that has completely responded to the Sonic Hedgehog inhibitors, confirmed by a tissue sample. People with certain conditions, such as distant spread of cancer or prior radiation to the treatment area, will not be eligible. The trial is not yet recruiting participants, but once it begins, those who join can expect thorough monitoring and support throughout the process as researchers evaluate the effectiveness of this new treatment strategy.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient over 18 years
  • Locally advanced non-recurrent BCC in complete response after first course of SHHi
  • Complete response has to be confirmed histologically
  • Available photography or CT scan before SHHi treatment allowing delineation of the initial tumor
  • Exclusion Criteria:
  • Patients with distant metastasis
  • Patients with Gorlin's syndrome
  • Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields
  • Pregnant women
  • Life expectancy less than 1 year
  • Inability to receive informed consent
  • Inability to participate in the entire study
  • Lack of social security coverage
  • Refusal to sign consent

About University Hospital, Lille

University Hospital Lille is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to enhancing therapeutic options and improving patient outcomes, University Hospital Lille collaborates with researchers, healthcare professionals, and industry partners to ensure rigorous scientific standards and ethical practices in all clinical trials.

Locations

Patients applied

0 patients applied

Trial Officials

Laurent Mortier, MD,PhD

Principal Investigator

University Hospital, Lille

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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