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
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
266
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.
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
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
...and 12 more locations
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.
Time frame: Up to 54 months
Local recurrence-free survival (lrFS)
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.
Time frame: Up to 54 months
Metastatic recurrence-free survival (mFS)
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.
Time frame: Up to 54 months
Overall Survival (OS)
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.
Time frame: Up to 54 months
Tolerance/toxicity
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
Time frame: Up to 54 months
Quality of Life (QoL)
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.
Time frame: Up to 54 months
Interest of radiotherapy in the subgroup of patients over 75 years old
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.
Time frame: Up to 54 months
Interest of radiotherapy in the subgroup of patients with Perineural Neoplastic Invasion (PNI)
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.
Time frame: Up to 54 months
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