Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence
- Conditions
- Registration Number
- NCT06692556
- Lead Sponsor
- Centre Leon Berard
- 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).
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- 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 clinic...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 266
- Patients ≥ 18 years of age at the time of signing informed consent to participate;
- Patient with histologically confirmed, localized skin squamous cell carcinoma; Note bene: patients with carcinoma of the external auditory canal may be included in the study;
- Patient treated with complete excision surgery (R0), regardless of margin (inframillimetric or supramillimetric);
- High risk disease defined by: presence of a microscopic PNI without/with another risk factor (among those mentioned below) OR presence of 2-3 risk factors other than microscopic PNI; Note Bene: The risk factors selected are immunosuppression (only haematopathy with or without treatment) , a tumor diameter >20mm, specific location (lip/ear/temple), deep invasion (thickness >6mm or invasion beyond subcutaneous fat), low differentiation or desmoplasia;
- Patient informed and having signed consent to participate in the study;
- Patient affiliated with a health insurance plan (or beneficiary of such a plan).
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Patient with in situ or mixed SCC;
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History of SCC at high risk of relapse in the same territory (head and neck, trunk or limb) in the 2 years preceding the date of randomization;
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History of SCC having received systemic treatment;
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Patient with SCC located in the endonasal, intra-oral, anogenital or vulvar mucosa;
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Patient with recurrent SCC or SCC at very high risk of relapse defined by one of the following criteria:
- PNI with > 2 other risk factors,
- > 3 risk factors,
- bone invasion,
- immunosuppression by immunosuppressive treatments (whatever the reason).
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Patient with SCC with a single risk factor other than PNI;
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Patient with SCC with lymph node or distant metastasis;
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Patient with a history of solid cancer undergoing chemotherapy;
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Patient with a contraindication to radiotherapy;
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Patient with a history of radiotherapy in the area of the lesion;
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Participation in another clinical trial that may interfere with the assessment of the primary endpoint;
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Patient under guardianship or curatorship or deprived of liberty;
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Pregnant or breastfeeding woman.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Disease-Free Survival (DFS) Up to 54 months 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.
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- Secondary Outcome Measures
Name Time Method Interest of radiotherapy in the subgroup of patients over 75 years old Up to 54 months 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.
Local recurrence-free survival (lrFS) Up to 54 months lrFS is defined as the time elapsed between the date of randomization and the date of metastatic recurrence or death from any cause. Patients without events at the analysis date will be censored at the last date of news without local disease. Death or metastatic recurrence will be considered as competing events.
Metastatic recurrence-free survival (mFS) Up to 54 months mFS 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.
Overall Survival (OS) Up to 54 months 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.
Tolerance/toxicity Up to 54 months 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 numbe...
Quality of Life (QoL) Up to 54 months 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 global...
Interest of radiotherapy in the subgroup of patients with Perineural Neoplastic Invasion (PNI) Up to 54 months 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.
Trial Locations
- Locations (22)
Centre Georges François Leclerc
🇫🇷Dijon, Côte-d'Or, France
Centre Hospitalier Romans - Hopitaux Drôme Nord
🇫🇷Romans-sur-Isère, Drôme, France
Centre de Radiothérapie Marie Curie
🇫🇷Valence, Drôme, France
Centre Hospitalier de Valence
🇫🇷Valence, Drôme, France
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
🇫🇷Brest, Finistère, France
Centre Hospitalier Universitaire de Bordeaux
🇫🇷Pessac, Gironde, France
Centre Hospitalier Annecy Genevois
🇫🇷Épagny-Metz-Tessy, Haute-Savoie, France
Hôpital Bichat Claude-Bernard
🇫🇷Paris, Ile-de-France, France
Centre Hospitalier Universitaire de Rennes
🇫🇷Rennes, Ille-et-Vilaine, France
Centre Hospitalier Universitaire de Grenoble-Alpes
🇫🇷La Tronche, Isère, France
Centre Hospitalier Simone Veil de Blois
🇫🇷Blois, Loir-et-Cher, France
Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
🇫🇷Nantes, Loire-Atlantique, France
Centre hospitalier de Roanne
🇫🇷Roanne, Loire, France
Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord
🇫🇷Saint Priest en Jarez, Loire, France
Institut Godinot
🇫🇷Reims, Marne, France
Institut de Cancérologie de Lorraine
🇫🇷Vandoeuvre-les-Nancy, MMeurthe-et-Moselle, France
Groupe Hospitalier Bretagne Sud
🇫🇷Lorient, Morbihan, France
Centre Hospitalier Universitaire Estaing
🇫🇷Clermont-Ferrand, Puy-de-Dôme, France
Centre Hospitalier Universitaire Rouen - Hôpital Charles Nicolle
🇫🇷Rouen, Seine-Maritime, France
Centre Hospitalier Universitaire Amiens-Picardie
🇫🇷Amiens, Somme, France
Hôpital d'instruction des armées Sainte-Anne
🇫🇷Toulon, Var, France
Centre Léon Bérard
🇫🇷Lyon, France