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

April 21, 2026 updated by: Centre Leon Berard

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The use of adjuvant radiotherapy appears to provide clinical benefit, both theoretically and based on available retrospective data. This is why some patients already benefit from this complementary treatment. However, given the lack of prospective data, the use of adjuvant radiotherapy is based on heterogeneous criteria, depending on the choice of the clinician in charge of the patient or the habits of his institution.

The sponsor team therefore propose to conduct a national prospective study to compare the efficacy and safety of a strategy integrating adjuvant radiotherapy versus a strategy based on surveillance in patients with SCC at high risk of recurrence.

Considering that there is no validated standard after surgery for patients with a high risk of recurrence, it is not possible to determine a standard arm and an experimental arm. This study therefore falls within the framework of a Research Involving the Human Person of Category 2.

This protocol constitutes the first prospective evaluation of adjuvant radiotherapy, within the framework of a comparative study. This study will thus make it possible to avoid the use of this therapeutic alternative, without rigorous evaluation in a prospective framework. Its robust methodology will make it possible to determine whether adjuvant radiotherapy provides a clinical benefit to patients at high risk of recurrence. It will modify the standards of care for this patient population.

Study Type

Interventional

Enrollment (Estimated)

266

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69373
        • Recruiting
        • Centre Léon Bérard
        • Contact:
        • Principal Investigator:
          • Mona AMINI-ADLE, Dr
        • Sub-Investigator:
          • Adeline PETRE, Dr
    • Auvergne-Rhône-Alpes
      • Le Puy-en-Velay, Auvergne-Rhône-Alpes, France, 43000
        • Withdrawn
        • Centre Hospitalier Emile Roux
      • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
    • Bourgogne-Franche-Comté
      • Dijon, Bourgogne-Franche-Comté, France, 21079
        • Active, not recruiting
        • Centre Georges François Leclerc
    • Drôme
      • Romans-sur-Isère, Drôme, France, 26102
        • Recruiting
        • Centre Hospitalier Romans - Hopitaux Drôme Nord
        • Contact:
        • Principal Investigator:
          • François SKOWRON, Dr
      • Valence, Drôme, France, 26000
        • Not yet recruiting
        • Centre de radiotherapie Marie Curie
        • Contact:
        • Principal Investigator:
          • Jean-Baptiste GUY, Dr
        • Sub-Investigator:
          • Julien LANGRAND-ESCURE, Dr
      • Valence, Drôme, France, 26000
        • Recruiting
        • Centre Hospitalier de Valence
        • Contact:
        • Principal Investigator:
          • Florent GRANGE, Dr
    • Finistère
      • Brest, Finistère, France, 29200
        • Withdrawn
        • Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
      • Brest, Finistère, France, 29200
        • Not yet recruiting
        • Hopital De La Cavale Blanche
        • Contact:
    • Gironde
      • Pessac, Gironde, France, 33604
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Bordeaux
    • Haute-Savoie
      • Metz-Tessy, Haute-Savoie, France, 74374
        • Recruiting
        • Centre Hospitalier Annecy Genevois
        • Contact:
        • Principal Investigator:
          • Julie DE QUATREBARBES, Dr
        • Sub-Investigator:
          • Amélie DUTHEIL, Dr
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35033
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Rennes
        • Contact:
        • Principal Investigator:
          • Monica DINULESCU, Dr
    • Isère
      • La Tronche, Isère, France, 38700
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Grenoble-Alpes
        • Contact:
        • Principal Investigator:
          • Sabiha TRABELSI-MESSAI, Dr
    • Loir-et-Cher
      • Blois, Loir-et-Cher, France, 41016
        • Recruiting
        • Centre Hospitalier Simone Veil de Blois
        • Contact:
        • Principal Investigator:
          • Guido BENS, Dr
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
        • Contact:
        • Principal Investigator:
          • Gaëlle QUEREUX, Dr
        • Sub-Investigator:
          • Lise BOUSSEMART, Dr
        • Sub-Investigator:
          • Casandra COLTOIU, Dr
        • Sub-Investigator:
          • Marie DAUDE, Dr
        • Sub-Investigator:
          • Fanny GOHARD, Dr
        • Sub-Investigator:
          • Sarah LE NAOUR, Dr
        • Sub-Investigator:
          • Marie PIROTH, Dr
    • MMeurthe-et-Moselle
      • Vandœuvre-lès-Nancy, MMeurthe-et-Moselle, France, 54519
        • Recruiting
        • Institut de Cancerologie de Lorraine
        • Contact:
        • Principal Investigator:
          • Sophie RENARD, Dr
        • Sub-Investigator:
          • Florence GRANEL BROCARD, Dr
    • Marne
      • Reims, Marne, France, 51726
        • Active, not recruiting
        • Institut Godinot
    • Morbihan
      • Lorient, Morbihan, France, 56322
        • Recruiting
        • Groupe Hospitalier Bretagne Sud
        • Contact:
        • Principal Investigator:
          • Caroline JACOBZONE-LEVEQUE, Dr
        • Sub-Investigator:
          • Christian SIRE, Dr
        • Sub-Investigator:
          • Claire-Alice DE SALINS, Dr
        • Sub-Investigator:
          • Guillaume BERA, Dr
        • Sub-Investigator:
          • Kévin CHASSAIN, Dr
    • New Aquitaine
      • Bordeaux, New Aquitaine, France, 33076
        • Not yet recruiting
        • CHU de Bordeaux - Hôpital Saint André
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Léa DOUSSET, Dr
        • Sub-Investigator:
          • Caroline DUTRIAUX, Dr
        • Sub-Investigator:
          • Anne PHAM-LEDARD, Dr
        • Sub-Investigator:
          • Sorilla PREY, Dr
    • Normandy
      • Le Havre, Normandy, France, 76600
        • Not yet recruiting
        • Centre De Radiothérapie Guillaume Le Conquérant
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Laurent MARTIN, Dr
        • Sub-Investigator:
          • Renata PEREIRA, Dr
    • Pays de la Loire Region
      • Roanne, Pays de la Loire Region, France, 42300
        • Recruiting
        • Centre hospitalier de Roanne
        • Contact:
        • Principal Investigator:
          • Amel BLANCHARD, Dr
        • Sub-Investigator:
          • Petre LUPU BRATILOVEANU, Dr
      • Saint Priest En Jarez, Pays de la Loire Region, France, 42271
        • Recruiting
        • Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord
        • Contact:
        • Principal Investigator:
          • Elodie GUILLAUME, Dr
        • Sub-Investigator:
          • Jean-Luc PERROT, DrNicolas
        • Sub-Investigator:
          • Nicolas VIAL, Dr
        • Sub-Investigator:
          • Saïd SOLTANI, Dr
        • Sub-Investigator:
          • Eric JADAUD, Dr
    • Provence-Alpes-Côte d'Azur Region
      • Nice, Provence-Alpes-Côte d'Azur Region, France, 06189
    • Puy-de-Dôme
      • Clermont-Ferrand, Puy-de-Dôme, France, 63033
        • Recruiting
        • Centre Hospitalier Universitaire Estaing
        • Contact:
        • Principal Investigator:
          • Sandrine MANSARD, Dr
        • Sub-Investigator:
          • Marie BACHELERIE, Dr
        • Sub-Investigator:
          • Jacques ROUANET, Dr
        • Sub-Investigator:
          • Michel D'INCAN, Dr
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76031
        • Not yet recruiting
        • Centre Hospitalier Universitaire Rouen - Hôpital Charles Nicolle
        • Contact:
        • Principal Investigator:
          • Anne-Bénédicte DUVAL-MODESTE, Dr
    • Somme
      • Amiens, Somme, France, 80054
        • Active, not recruiting
        • Centre Hospitalier Universitaire Amiens-Picardie
    • Var
      • Toulon, Var, France, 83800
        • Withdrawn
        • Hôpital d'instruction des armées Sainte-Anne
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75877
        • Active, not recruiting
        • Hopital Bichat Claude-Bernard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Surveillance

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.
Active Comparator: Adjuvant radiotherapy

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS)
Time Frame: 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)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence-free survival (lrFS)
Time Frame: 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)
lrFS is defined as the time from randomization (or surgery) to the first occurrence of regional recurrence or death from any cause.
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)
Time Frame: 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)
RrFS is The time from randomization (or surgery) to the first occurrence of regional recurrence or death from any cause, whichever came first
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)
Time Frame: 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)
MrFS is defined as the time elapsed between the date of randomization and the date of metastatic recurrence or death from any cause. Patients without an event at the analysis date will be censored at the last date of news without metastatic disease.
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)
Time Frame: 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
OS is defined as the time from the date of randomization to the date of death from any cause. Patients without an event at the analysis date will be censored at the last date of death-free news.
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
Time Frame: 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)
The safety will be described according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTC AE) Version 5 grid by reporting the number and percentage of patients with toxicity by grade. Adverse events will be coded according to the MedDRA® dictionary and will be described by System Organ Class and Preferred Term. The number of patients with at least one AE by grade, at least one AE related to treatment, at least one serious AE (according to pharmacovigilance), at least one serious AE related to treatment will be described by treatment arm. A listing of serious AEs will be published
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)
Quality of Life (QoL)
Time Frame: Inclusion, every 4 months for 1 year, assessed up to 36 months of follow-up from the last patient enrolled or until the 120th event occurs (wichever comes first)
QoL, will be assessed using the EORTC QLQ-C30 and the EORTC QLQ-ELD14 for the patients ≥ 75 years of age. The difference between the scores at inclusion and during follow-up will be calculated per patient. A difference of 10 points on each score will be considered clinically relevant. A graphic representation in the form of a spider plot will allow to globally visualize the evolution on all the items between the different measurement times.
Inclusion, every 4 months for 1 year, assessed up to 36 months of follow-up from the last patient enrolled or until the 120th event occurs (wichever comes first)
Interest of radiotherapy in the subgroup of patients over 75 years old
Time Frame: 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)
Due to the stratification, the aged population will be well distributed in a balanced way between the treatment arms. The main efficacy criterion and quality of life of this subpopulation will be studied in more detail.
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)
Interest of radiotherapy in the subgroup of patients with Perineural Neoplastic Invasion (PNI)
Time Frame: 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)
Due to the stratification, the population with PNI will be well balanced among the treatment arms. The main efficacy criterion and quality of life of this subpopulation will be studied in more detail.
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 Outcome Measures

Outcome Measure
Time Frame
Progression-free survival after loco-regional recurrence salvage therapy in the Surveillance group
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Mona AMINI-ADLE, Dr, Centre Léon Bérard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2025

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPINO-RT (ET24-046)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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