Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence

NCT06692556 | Recruiting Phase 3

• 1 other identifier: SPINO-RT (ET24-046)
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 28

Brief Summary

The goal of this clinical trial is to evaluate a strategy integrating adjuvant radiation therapy versus strategy based on monitoring in the treatment of carcinomas spinocellular with high risk of recurrence (SCC). The investigators will compare the disease-free survival (DFS) of patients treated with adjuvant radiation therapy versus surveillance in high risk of recurrence SCC. The main question it aims to answer is: Is DFS different between the "adjuvant radiotherapy" group and the "surveillance" group? Participants will:

• be distributed in one of the two arms
• will be followed up every 4 months for 2 years, then every 6 months (clinical examination, identification of concomitant treatments, imaging, quality-of-life questionnaire)
• followed up until their death or their progression whether local, regional or metastatic

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Keywords

Squamous cell carcinomas at high risk of recurrence; Adjuvant radiotherapy; Surveillance; Peri Nervous System Sheathing

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS)

  DFS is defined as the time from the date of randomization to the date of recurrence (local, lymph node or metastatic) or death from any cause. A new skin lesion will not be considered a statistical event. Patients without an event at the date of analysis will be censored at the last date of new disease-free status. DFS will be estimated by the Kaplan Meier method and described in terms of median in each arm. DFS distributions will be compared between arms using a Log-Rank test. The hazard ratio from a Cox model will be calculated and presented with its 95% confidence interval. The rate of patients without recurrence at 1 and 2 years post-randomization will also be presented with their associated confidence interval.

  Inclusion, every 4 months for 2 years and then every 6 months until death or progression, assessed up to 36 months of follow-up from the last patient enrolled or until the 120th event occurs (wichever comes first)

Secondary Outcomes (8)

• Local recurrence-free survival (lrFS)

  Inclusion, every 4 months for 2 years and then every 6 months until death or progression, assessed up to 36 months of follow-up from the last patient enrolled or until the 120th event occurs (wichever comes first)

• Regional Recurrence-Free Survival (RrFS)

  Inclusion, every 4 months for 2 years and then every 6 months until death or progression, assessed up to 36 months of follow-up from the last patient enrolled or until the 120th event occurs (wichever comes first)

• Metastatic recurrence-free survival (MrFS)

  Inclusion, every 4 months for 2 years and then every 6 months until death or progression, assessed up to 36 months of follow-up from the last patient enrolled or until the 120th event occurs (wichever comes first)

• Overall Survival (OS)

  every 4 months for 2 years, then every 6 months until the condition progresses or the patient dies. If progression, updates annually. Assessed up to 36 months of follow-up from the last patient enrolled or until the 120th event occurs (wichever comes fir

• Tolerance/toxicity

  Inclusion, every 4 months for 2 years and then every 6 months until death or progression, assessed up to 36 months of follow-up from the last patient enrolled or until the 120th event occurs (wichever comes first)

Other Outcomes (1)

• Progression-free survival after loco-regional recurrence salvage therapy in the Surveillance group

  Inclusion, every 4 months for 2 years and then every 6 months until death or progression, assessed up to 36 months of follow-up from the last patient enrolled or until the 120th event occurs (wichever comes first)

Study Arms (2)

Adjuvant radiotherapy

ACTIVE COMPARATOR

Radiation therapy should be started within 8 to 12 weeks after surgery. An equivalent dose of 45 to 50 Gy will be delivered on the operating bed. The irradiation techniques used may be either external radiation therapy with high-energy photons or electrons or brachytherapy. Patients will be monitored regularly until the date of the first local, regional or metastatic relapse, or until the date of death if they do not relapse. Regardless of the type of relapse, remedial treatments will be left to the The investigator's discretion; they will be collected in the data collection book as well as data on subsequent relapses, up to the first metastatic relapse.

Radiation: Adjuvant radiotherapy

Surveillance

NO INTERVENTION

Patients will not receive any treatment after surgery and will be monitored regularly until the date of their first local, regional or metastatic relapse, or until the date of death if they do not relapse. Regardless of the type of relapse, the treatment to be used is left to the discretion of the investigator; it will be collected in the data collection book as well as data on subsequent relapses up to the first metastatic relapse.

Interventions

Adjuvant radiotherapy RADIATION

Patients will receive an adjuvant radiotherapy corresponding to an equivalent dose of 45 to 50 Gy (Equivalent Dose in 2 Gy Fractions \[EQD2\] with a tumor alpha/beta ratio of 10 Gy) delivered on the operating bed. Patients will be treated by : * either external radiation therapy using high-energy electrons or photons: * 45 Gy in 15 fractions of 3 Gy * 50 Gy in 25 fractions of 2 Gy * or interstitial brachytherapy or brachytherapy via skin applicators: * 36 Gy in 8 fractions of 4.5 Gy * 36 Gy in 9 fractions of 4 Gy * 40 Gy in 8 fractions of 5 Gy Radiation therapy should be started within 8 weeks after surgery (or 10 if delayed healing). Patients will be monitored regularly until the date of the first relapse (local, regional or metastatic), or until the date of death (if no relapse). Regardless of the type of relapse, remedial treatments will be left to the the investigator's discretion up to the first metastatic relapse.

Adjuvant radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (28)

Centre Hospitalier Emile Roux

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

WITHDRAWN

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

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

NOT YET RECRUITING

Centre Georges François Leclerc

Dijon, Bourgogne-Franche-Comté, 21079, France

ACTIVE NOT RECRUITING

Centre Hospitalier Romans - Hopitaux Drôme Nord

Romans-sur-Isère, Drôme, 26102, France

RECRUITING

Centre de Radiothérapie Marie Curie

Valence, Drôme, 26000, France

NOT YET RECRUITING

Centre Hospitalier de Valence

Valence, Drôme, 26000, France

RECRUITING

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

Brest, Finistère, 29200, France

WITHDRAWN

Hôpital de la Cavale Blanche

Brest, Finistère, 29200, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Pessac, Gironde, 33604, France

ACTIVE NOT RECRUITING

Centre Hospitalier Annecy Genevois

Metz-Tessy, Haute-Savoie, 74374, France

RECRUITING

Centre Hospitalier Universitaire de Rennes

Rennes, Ille-et-Vilaine, 35033, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Grenoble-Alpes

La Tronche, Isère, 38700, France

NOT YET RECRUITING

Centre Hospitalier Simone Veil de Blois

Blois, Loir-et-Cher, 41016, France

RECRUITING

Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu

Nantes, Loire-Atlantique, 44093, France

RECRUITING

Institut Godinot

Reims, Marne, 51726, France

ACTIVE NOT RECRUITING

Institut de Cancérologie de Lorraine

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

RECRUITING

Groupe Hospitalier Bretagne Sud

Lorient, Morbihan, 56322, France

RECRUITING

CHU de Bordeaux - Hôpital Saint André

Bordeaux, New Aquitaine, 33076, France

NOT YET RECRUITING

Centre De Radiothérapie Guillaume Le Conquérant

Le Havre, Normandy, 76600, France

NOT YET RECRUITING

Centre hospitalier de Roanne

Roanne, Pays de la Loire Region, 42300, France

RECRUITING

Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord

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

RECRUITING

Centre Antoine Lacassagne

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

NOT YET RECRUITING

Centre Hospitalier Universitaire Estaing

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

RECRUITING

Centre Hospitalier Universitaire Rouen - Hôpital Charles Nicolle

Rouen, Seine-Maritime, 76031, France

NOT YET RECRUITING

Centre Hospitalier Universitaire Amiens-Picardie

Amiens, Somme, 80054, France

ACTIVE NOT RECRUITING

Hôpital d'instruction des armées Sainte-Anne

Toulon, Var, 83800, France

WITHDRAWN

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Hôpital Bichat Claude-Bernard

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

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Radiotherapy, Adjuvant

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy

Study Officials

• Mona AMINI-ADLE, Dr

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien GAUTIER

CONTACT

+33 4.26.55.68.29; julien.gautier@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will be randomized (ratio 1:1) using an online platform into one of the two study arms: * "Adjuvant radiotherapy" arm (=133), * "Surveillance" arm (n=133)

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: February 21, 2025
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

FR (28)