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

NCT ID: NCT06692556

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2029-06-30

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

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.

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Adjuvant radiotherapy

Radiation therapy should be started within 8 to 10 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.

Group Type: ACTIVE_COMPARATOR

Adjuvant radiotherapy

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• Patient with in situ or mixed SCC;
• 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;
• History of SCC having received systemic treatment;
• Patient with SCC located in the endonasal, intra-oral, anogenital or vulvar mucosa;
• 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).
• Patient with SCC with a single risk factor other than PNI;
• Patient with SCC with lymph node or distant metastasis;
• Patient with a history of solid cancer undergoing chemotherapy;
• Patient with a contraindication to radiotherapy;
• Patient with a history of radiotherapy in the area of the lesion;
• Participation in another clinical trial that may interfere with the assessment of the primary endpoint;
• Patient under guardianship or curatorship or deprived of liberty;
• Pregnant or breastfeeding woman.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mona AMINI-ADLE, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

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

Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu

Nantes, Loire-Atlantique, France

Institut Godinot

Reims, Marne, France

Institut de Cancérologie de Lorraine

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

Groupe Hospitalier Bretagne Sud

Lorient, Morbihan, France

Centre hospitalier de Roanne

Roanne, Pays de la Loire Region, France

Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord

Saint Priest En Jarez, Pays de la Loire Region, 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

Hôpital Bichat Claude-Bernard

Paris, Île-de-France Region, France

Countries

France

Central Contacts

Julien GAUTIER

Role: CONTACT

julien.gautier@lyon.unicancer.fr

+33 4.26.55.68.29

Facility Contacts

Gilles TRUC, Dr

Role: primary

gtruc@cgfl.fr

+33 3 80 73 75 18

François SKOWRON, Dr

Role: primary

f.skowron@hopitaux-drome-nord.fr

+33 4 75 05 75 80

Jean-Baptiste GUY, Dr

Role: primary

dr.guy@cmc-valence.org

Florent GRANGE, Dr

Role: primary

fgrange@valence.fr

+33 4 75 75 75 49

Vincent BOURBONNE, Dr

Role: primary

vincent.bourbonne@chu-brest.fr

+33 2 98 22 33 98

Nora OUHABRACHE, Dr

Role: primary

nora.ouhabrache@chu-bordeaux.fr

+33 5 57 62 33 12

Julie DE QUATREBARBES, Dr

Role: primary

jdequatrebarbes@ch-annecygenevois.fr

+33 4 50 63 68 63

Monica DINULESCU, Dr

Role: primary

monica.dinulescu@chu-rennes.fr

Sabiha TRABELSI-MESSAI, Dr

Role: primary

strabelsimessai@chu-grenoble.fr

+33 4 76 76 66 16

Guido BENS, Dr

Role: primary

bensgui@ch-blois.fr

Gaëlle QUEREUX, Dr

Role: primary

gaelle.quereux@chu-nantes.fr

+33 2 40 08 31 44

Antonio Manuel DA SILVA RIBEIRO MOTA, Dr

Role: primary

antonio.dasilvaribeiromota@reims.unicancer.fr

+33 3 26 50 43 63

Sophie RENARD, Dr

Role: primary

s.renard@nancy.unicancer.fr

+33 3 83 59 86 10

Caroline JACOBZONE-LEVEQUE, Dr

Role: primary

c.jacobzoneleveque@ghbs.bzh

+33 6 16 98 31 79

Amel BLANCHARD, Dr

Role: primary

amel.blanchard@ch-roanne.fr

+33 4 77 44 32 77

Elodie GUILLAUME, Dr

Role: primary

elodie.guillaume@chu-st-etienne.fr

+33 4 77 91 71 02

Sandrine MANSARD, Dr

Role: primary

smansard@chu-clermontferrand.fr

+33 4 73 75 05 50

Anne-Bénédicte DUVAL-MODESTE, Dr

Role: primary

anne-benedicte.duval-modeste@chu-rouen.fr

+33 2 32 88 81 41

Alexandre COUTTE, Dr

Role: primary

coutte.alexandre@chu-amiens.fr

+33 3 22 45 56 40

Safia ABED, Dr

Role: primary

abed.safia@gmail.com

Mona AMINI-ADLE, Dr

Role: primary

mona.amini-adle@lyon.unicancer.fr

+33 4 78 78 59 96

Florence BRUNET-POSSENTI, Dr

Role: primary

florence.brunet-possenti@aphp.fr

+33 6 79 85 46 98

Other Identifiers

SPINO-RT (ET24-046)

Identifier Type: -

Identifier Source: org_study_id