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Radiation or watchful waiting? new trial for aggressive skin cancer

NCT ID NCT06692556

Disease control Sponsor: Centre Leon Berard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares two strategies for people with high-risk cutaneous squamous cell carcinoma after surgery: adding radiation therapy versus simply monitoring. About 266 participants will be randomly assigned to one of the two groups and followed for at least two years. The main goal is to see whether radiation improves disease-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adjuvant radiotherapy
What this could lead to
If it works, this could show that adding radiation after surgery reduces the chance of cancer coming back in high-risk patients.
What could go wrong
This is a phase 3 trial, but it's still possible that radiation offers no benefit over monitoring, or that side effects outweigh any gain. Results may not apply to all patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 266 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jun 2031

An estimate. End dates often move.

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: 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.

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Conditions

The condition(s) this trial relates to.

skin squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous squamous cell carcinoma (CSCC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Bordeaux - Hôpital Saint André

    NOT_YET_RECRUITING

    Bordeaux, New Aquitaine, 33076, France

  • Centre Antoine Lacassagne

    NOT_YET_RECRUITING

    Nice, Provence-Alpes-Côte d'Azur Region, 06189, France

  • Centre De Radiothérapie Guillaume Le Conquérant

    NOT_YET_RECRUITING

    Le Havre, Normandy, 76600, France

  • Centre Georges François Leclerc

    ACTIVE_NOT_RECRUITING

    Dijon, Bourgogne-Franche-Comté, 21079, France

  • Centre Hospitalier Annecy Genevois

    RECRUITING

    Metz-Tessy, Haute-Savoie, 74374, France

  • Centre Hospitalier Emile Roux

    WITHDRAWN

    Le Puy-en-Velay, Auvergne-Rhône-Alpes, 43000, France

  • Centre Hospitalier Romans - Hopitaux Drôme Nord

    RECRUITING

    Romans-sur-Isère, Drôme, 26102, France

  • Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

    WITHDRAWN

    Brest, Finistère, 29200, France

  • Centre Hospitalier Simone Veil de Blois

    RECRUITING

    Blois, Loir-et-Cher, 41016, France

  • Centre Hospitalier Universitaire Amiens-Picardie

    ACTIVE_NOT_RECRUITING

    Amiens, Somme, 80054, France

  • Centre Hospitalier Universitaire Estaing

    RECRUITING

    Clermont-Ferrand, Puy-de-Dôme, 63033, France

  • Centre Hospitalier Universitaire Rouen - Hôpital Charles Nicolle

    NOT_YET_RECRUITING

    Rouen, Seine-Maritime, 76031, France

  • Centre Hospitalier Universitaire de Bordeaux

    ACTIVE_NOT_RECRUITING

    Pessac, Gironde, 33604, France

  • Centre Hospitalier Universitaire de Grenoble-Alpes

    NOT_YET_RECRUITING

    La Tronche, Isère, 38700, France

  • Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu

    RECRUITING

    Nantes, Loire-Atlantique, 44093, France

  • Centre Hospitalier Universitaire de Rennes

    NOT_YET_RECRUITING

    Rennes, Ille-et-Vilaine, 35033, France

  • Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord

    RECRUITING

    Saint Priest En Jarez, Pays de la Loire Region, 42271, France

  • Centre Hospitalier de Valence

    RECRUITING

    Valence, Drôme, 26000, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69373, France

  • Centre de Radiothérapie Marie Curie

    NOT_YET_RECRUITING

    Valence, Drôme, 26000, France

  • Centre hospitalier de Roanne

    RECRUITING

    Roanne, Pays de la Loire Region, 42300, France

  • Groupe Hospitalier Bretagne Sud

    RECRUITING

    Lorient, Morbihan, 56322, France

  • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

    NOT_YET_RECRUITING

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

  • Hôpital Bichat Claude-Bernard

    ACTIVE_NOT_RECRUITING

    Paris, Île-de-France Region, 75877, France

  • Hôpital d'instruction des armées Sainte-Anne

    WITHDRAWN

    Toulon, Var, 83800, France

  • Hôpital de la Cavale Blanche

    NOT_YET_RECRUITING

    Brest, Finistère, 29200, France

  • Institut Godinot

    ACTIVE_NOT_RECRUITING

    Reims, Marne, 51726, France

  • Institut de Cancérologie de Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, MMeurthe-et-Moselle, 54519, France

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