Phase III Study Evaluating Induction Chemotherapy Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced SCCA

PHASE3RecruitingINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

February 26, 2024

Primary Completion Date

February 1, 2029

Study Completion Date

February 1, 2030

Conditions
Anal Cancer
Interventions
DRUG

induction chemotherapy (mDCF)

"Induction chemotherapy consists of mDCF administered every 2 weeks:~* Docetaxel (40 mg/m², day 1),~* Cisplatin (40 mg/m², day 1)~* 5-FU (1200 mg/m²/day IV for 2 days)"

DRUG

Concomitant chemotherapy (Capecitabin + Mitomycin-C)

Concomitant Chemotherapy consists of Mitomycin-C (10 mg/m2 intravenous infusion at D1 and D29) and Capecitabine (1650 mg/m²/day divided in two oral intakes 825 mg/m² twice a day, five days a week). Patients should be counseled to only take capecitabine on the days when radiotherapy is being given

RADIATION

radiotherapy

"Radiotherapy consists of conformational intensity-modulated external irradiation with simultaneous integrated boost (IMRT-SIB) with 2 level of dose (30 sessions)~* 49.5 Gy (5 x 1.65 Gy/week) to the pelvis~* 60 Gy (5 x 2 Gy /week) to the primary tumor and initially involved nodes"

Trial Locations (114)

Unknown

NOT_YET_RECRUITING

AGEN-Cromg, Agen

NOT_YET_RECRUITING

Clinique Calabet, Agen

NOT_YET_RECRUITING

AIX EN PROVENCE CH Pays d'Aix, Aix-en-Provence

NOT_YET_RECRUITING

Amiens - Clinique de L'Europe, Amiens

NOT_YET_RECRUITING

ANTONY Hôpital Privé, Antony

RECRUITING

Argenteuil - Ch, Argenteuil

NOT_YET_RECRUITING

ARRAS Les Bonnettes, Arras

NOT_YET_RECRUITING

ARRAS Marie Curie, Arras

NOT_YET_RECRUITING

AURILLAC-Henri Mondor, Aurillac

NOT_YET_RECRUITING

Centre Medico Chirurgical, Aurillac

RECRUITING

AUXERRE CH GHT Unyon, Auxerre

RECRUITING

Avignon Icap, Avignon

RECRUITING

Avranches - Hopital Prive de La Baie, Avranches

NOT_YET_RECRUITING

Bayonne- Clinique Belharra, Bayonne

NOT_YET_RECRUITING

BEAUVAIS-Simone Veil, Beauvais

RECRUITING

Besancon Chu, Besançon

NOT_YET_RECRUITING

Beuvry - Clinique Ambroise Pare, Beuvry

NOT_YET_RECRUITING

Beuvry Pierre Curie, Beuvry

RECRUITING

Bordeaux - Privé - Tivoli, Bordeaux

RECRUITING

BORDEAUX-Institut Bergonié, Bordeaux

RECRUITING

Institut Bergonié, Bordeaux

RECRUITING

Pessac - Chu -Haut Leveque, Bordeaux

NOT_YET_RECRUITING

Ch Duchenne, Boulogne-sur-Mer

RECRUITING

BREST Pasteur Lanroze, Brest

RECRUITING

CAEN Polyclinique du Parc, Caen

RECRUITING

CAEN-François Baclesse, Caen

NOT_YET_RECRUITING

Cahors -Ch, Cahors

NOT_YET_RECRUITING

Caluire Et Cuire-Infirmerie Protestante, Caluire-et-Cuire

RECRUITING

Chalon-Sur-Saone Hopital Sainte Marie, Chalon-sur-Saône

RECRUITING

Chambery Ch, Chambéry

RECRUITING

Chambray Les Tours-Roc37, Chambray-lès-Tours

NOT_YET_RECRUITING

Centre Jean Perrin, Clermont-Ferrand

NOT_YET_RECRUITING

Chu Estaing, Clermont-Ferrand

NOT_YET_RECRUITING

Centre de Radiothérapie Savoie Nord, Contamine-sur-Arve

NOT_YET_RECRUITING

Clinique de Flandre, Coudekerque-Branche

RECRUITING

CRETEIL-Henri Mondor CHU, Créteil

NOT_YET_RECRUITING

DAX CH, Dax

RECRUITING

DECHY-Léonard de Vinci, Dechy

RECRUITING

Dijon - Chu François Mitterrand, Dijon

NOT_YET_RECRUITING

DIJON-GF Leclerc, Dijon

RECRUITING

DIJON-Institut de Cancérologie de Bourgogne, Dijon

NOT_YET_RECRUITING

Ghm Grenoble - Institut Daniel Hollard, Grenoble

RECRUITING

LA ROCHE-SUR-YON CHD Vendée, La Roche-sur-Yon

NOT_YET_RECRUITING

Guillaume Le Conquérant, Le Havre

NOT_YET_RECRUITING

LE HAVRE-l'Estuaire, Le Havre

RECRUITING

LE MANS-CH Victor Hugo, Le Mans

NOT_YET_RECRUITING

Lille - Hopital Prive La Louviere, Lille

NOT_YET_RECRUITING

Limoges - Polyclinique Francois Chenieux, Limoges

NOT_YET_RECRUITING

Limoges-Chu Dupuytren, Limoges

NOT_YET_RECRUITING

LONGJUMEAU-GHNE Hôpital d'Antony, Longjumeau

RECRUITING

Lorient - Groupe Hospitalier Bretagne Sud - Site Du Scorff, Lorient

RECRUITING

LYON Jean Mermoz, Lyon

NOT_YET_RECRUITING

LYON- Léon Bérard, Lyon

NOT_YET_RECRUITING

LYON-Saint Joseph, Lyon

RECRUITING

MARSEILLE Institut Paoli Calmettes, Marseille

RECRUITING

MARSEILLE Saint-Joseph, Marseille

RECRUITING

MARSEILLE-Hôpital la Timone, Marseille

NOT_YET_RECRUITING

Montbeliard Ch, Montbéliard

RECRUITING

MONTPELLIER-ICM Val d'Aurelle, Montpellier

RECRUITING

Mougins Cac, Mougins

RECRUITING

MULHOUSE CH Emile Muller, Mulhouse

NOT_YET_RECRUITING

Nantes - Hopital Prive Du Confluent, Nantes

NOT_YET_RECRUITING

NEUILLY-SUR-SEINE GH Hartmann, Neuilly-sur-Seine

RECRUITING

NICE-Antoine LACASSAGNE, Nice

NOT_YET_RECRUITING

Centre Hospitalier, Niort

NOT_YET_RECRUITING

Nimes Chu, Nîmes

NOT_YET_RECRUITING

ORLEANS Centre Hospitalier Régional, Orléans

RECRUITING

OSNY-CHP Sainte-Marie, Osny

NOT_YET_RECRUITING

Paris - Ap-Hp - Hopital Tenon, Paris

NOT_YET_RECRUITING

Paris - Chu -Saint Louis Aphp, Paris

RECRUITING

PARIS GHD Croix Saint-Simon, Paris

RECRUITING

PARIS Hopital Europeen Georges-Pompidou, Paris

RECRUITING

PARIS Institut Curie, Paris

RECRUITING

PARIS-Saint Joseph, Paris

NOT_YET_RECRUITING

Pau Groupe de Radiotherapie Et D'Oncologie Des Pyrenees, Pau

RECRUITING

PERIGUEUX-Hôpital Francheville, Périgueux

NOT_YET_RECRUITING

Plerin Hopital Prive Des Cotes D'Armor - Centre Cario, Plérin

RECRUITING

POITIERS- CHU la Miletrie, Poitiers

NOT_YET_RECRUITING

PRINGY-Annecy Genevois CH, Pringy

RECRUITING

REIMS-CHU Robert Debré, Reims

RECRUITING

REIMS-Jean Godinot, Reims

NOT_YET_RECRUITING

Rennes - Centre Eugene Marquis, Rennes

NOT_YET_RECRUITING

Rennes Chu Pontchaillou, Rennes

NOT_YET_RECRUITING

RODEZ CH, Rodez

NOT_YET_RECRUITING

Hopitaux Prives Rouennais - Clinique Mathilde, Rouen

RECRUITING

ROUEN-Frédéric Joliot, Rouen

NOT_YET_RECRUITING

Saint Denis Ch, Saint-Denis

NOT_YET_RECRUITING

CHU, Saint-Etienne

RECRUITING

Saint Herblain Ico, Saint-Herblain

NOT_YET_RECRUITING

SAINT NAZAIRE CM l'Estuaire, Saint-Nazaire

NOT_YET_RECRUITING

Centre Hospitalier, Saint-Quentin

NOT_YET_RECRUITING

SARCELLES - Institut de Cancérologie Paris Nord, Sarcelles

NOT_YET_RECRUITING

Clinique Cote d'Emeraude, St-Malo

NOT_YET_RECRUITING

Saint Malo Ch, St-Malo

RECRUITING

Strasbourg Icans, Strasbourg

RECRUITING

STRASBOURG Sainte Anne, Strasbourg

NOT_YET_RECRUITING

Tarbes - Lourdes - Ch, Tarbes

RECRUITING

Tarbes - Polyclinique de L'Ormeau, Tarbes

NOT_YET_RECRUITING

Thonon Les Bains - Hopitaux Du Leman, Thonon-les-Bains

NOT_YET_RECRUITING

Centre de Radiothérapie Saint-Louis, Toulon

NOT_YET_RECRUITING

TOULON-Sainte Anne, Toulon

NOT_YET_RECRUITING

Toulouse - Oncopole Institut Claudius Regaud, Toulouse

RECRUITING

Toulouse Chu - Hopital Rangueil, Toulouse

RECRUITING

TOULOUSE-Clinique Pasteur, Toulouse

RECRUITING

TOURS CHU Trousseau, Tours

NOT_YET_RECRUITING

Valence - Centre Marie Curie, Valence

NOT_YET_RECRUITING

Valence Ch, Valence

NOT_YET_RECRUITING

VALENCE Drôme-Ardèche, Valence

RECRUITING

Vandoeuvre Les Nancy-Ic Lorraine, Vandœuvre-lès-Nancy

RECRUITING

VILLEJUIF Gustave Roussy, Villejuif

NOT_YET_RECRUITING

Centre de Radiothérapie Bayard, Villeurbanne

NOT_YET_RECRUITING

Villeurbanne Medipole Hopital Mutualiste Lyon, Villeurbanne

NOT_YET_RECRUITING

Reunion - Chu Sud, Saint-Pierre

NOT_YET_RECRUITING

La Reunion - Clinique Prive Sainte Clotilde, Sainte-Clotilde

All Listed Sponsors
collaborator

Fondation ARCAD

OTHER

lead

Federation Francophone de Cancerologie Digestive

OTHER