Adjuvant radiation versus monitoring after surgery for high-risk cutaneous squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 randomized study assigns adults with completely excised high-risk cutaneous squamous cell carcinoma to either adjuvant radiotherapy or active surveillance. The primary endpoint is disease-free survival, and participants are followed every 4 months for two years and then every 6 months with clinical exams, imaging, treatment tracking, and quality-of-life questionnaires. Eligible patients have R0 surgical excision and predefined high-risk features such as microscopic perineural invasion, large tumor size, specific high-risk locations (lip/ear/temple), deep invasion, or limited immunosuppression. The protocol is designed as the first prospective comparative evaluation to determine whether routine adjuvant radiotherapy improves outcomes versus observation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

I1. Patients aged ≥ 18 years at the time of signing the informed consent form; I2. Patients with histologically confirmed localized cutaneous squamous cell carcinoma;

Note: Patients with carcinoma of the external auditory canal may be included in the study;

I3. Patients treated with complete surgical excision (R0), regardless of the margin (submillimeter or supramillimeter);

I4. Disease with a high risk of recurrence defined by one of the following scenarios:

* presence of microscopic EPN without any other risk factors;
* presence of microscopic EPN with a single other risk factor;
* presence of 2 risk factors other than microscopic EPN;
* presence of 3 risk factors other than microscopic EPN;

Note: The risk factors considered are immunosuppression (limited to untreated hematologic disease), a tumor diameter \>20 mm (longest axis, measured preferably clinically, or, failing that, histologically), a specific location (lip/ear/temple), deep invasion (tumor thickness \>6 mm (Breslow) or invasion beyond the subcutaneous fat), poor differentiation, or desmoplasia;

I5. Patient informed and having signed a consent form to participate in the study; I6. Patient enrolled in a health insurance plan (or beneficiary of such a plan).

Exclusion Criteria:

NI1. Patients with in situ or mixed CEC; NI2. History of CEC with a high risk of recurrence in the same lymphatic drainage area (head and neck, trunk, or limb) within 2 years prior to the randomization date; NI3. History of CEC treated with systemic therapy; NI4. Patients with SCC localized to the endonasal, intraoral, anogenital, or vulvar mucosa;

NI5. Patients with recurrent SCC or SCC at very high risk of recurrence defined by one of the following criteria:

* EPN with ≥ 2 other risk factors,
* \> 3 risk factors,
* bone invasion,
* immunosuppression due to immunosuppressive treatments (regardless of the reason). NI6. Patients with CEC presenting a single risk factor other than EPN; NI7. Patient with CEC and lymph node or distant metastasis; NI8. Patient with a history of cancer undergoing systemic and/or locoregional anticancer treatment;

Note: Local treatment of cutaneous keratoses with fluoropyrimidines is permitted outside the theoretical radiation field);

NI9. Patient with a contraindication to radiation therapy; NI10. Patient with a history of radiation therapy to the site of the lesion; NI11. Participation in another clinical trial that may interfere with the assessment of the primary endpoint; NI12. Patient under legal guardianship or conservatorship, or deprived of liberty; NI13. Pregnant or breastfeeding woman.

Where it's running

• Centre Hospitalier Romans - Hopitaux Drôme Nord
  Romans-sur-Isère, Drôme, France Recruiting
• Centre Hospitalier de Valence
  Valence, Drôme, France Recruiting
• Centre Hospitalier Annecy Genevois
  Metz-Tessy, Haute-Savoie, France Recruiting
• Centre Hospitalier Simone Veil de Blois
  Blois, Loir-et-Cher, France Recruiting
• Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
  Nantes, Loire-Atlantique, France Recruiting
• Institut de Cancérologie de Lorraine
  Vandœuvre-lès-Nancy, MMeurthe-et-Moselle, France Recruiting

Study contacts

• Principal investigator: Mona AMINI-ADLE, Dr — Centre Leon Berard
• Study coordinator: Julien GAUTIER
• Email: julien.gautier@lyon.unicancer.fr
• Phone: +33 4.26.55.68.29

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.