Actively Recruiting
Phase III Study Evaluating Induction Chemotherapy Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced SCCA
Led by Federation Francophone de Cancerologie Digestive · Updated on 2025-09-02
310
Participants Needed
114
Research Sites
309 weeks
Total Duration
On this page
Sponsors
F
Federation Francophone de Cancerologie Digestive
Lead Sponsor
F
Fondation ARCAD
Collaborating Sponsor
AI-Summary
What this Trial Is About
Squamous cell carcinoma of the anus is still a rare disease but its incidence increases mostly due to its association with human papillomavirus (HPV). When localized, the standard treatment combines radiotherapy and chemotherapy with 5FU and mitomycin-C. Chemoradiotherapy (CRT) achieves a good outcome for early stage tumors (T1-T2 tumors without nodal involvement), but more advanced tumors (T3-T4 or N1) are associated with a dismal prognosis. About 35 % of such patients relapse within two years after the end of treatment Recently, for metastatic or recurrent tumors after chemoradiotherapy, a chemotherapy combining docetaxel, cisplatin and 5FU (modified DCF protocol) has given very good results with a median overall survival of 39.2 months in 2 French trials (Epitopes HPV01 and 02). Our idea is to propose a new strategy , associating this chemotherapy (mDCF) followed by chemoradiotherapy to improve efficacy of the treatment for patients with locally advanced anal cancers. To this end, The principal investigator propose a national, multicenter, randomized phase 3 clinical trial to compare induction chemotherapy with mDCF followed by chemoradiotherapy versus standard chemoradiotherapy for locally advanced anal canal cancer. the efficacy of the treatment will be evaluated by comparing disease-related event-free survival at 2 years according to the type of treatment. Other endpoints will also be evaluated such as overall survival and colostomy-free survival, treatment tolerability, response rate and quality of life. This trial will be offered to patients over 18 years of age with locally advanced anal cancer without metastasis (T3-4 or N1). It is open to patients over 75 years of age subject to a favorable evaluation by an oncogeriatrician. It is also open to immunocompromised patients (HIV+) if their immunity is well controlled under antiretroviral treatment.The standard chemoradiotherapy treatment consists of 33 sessions of radiation, one session per day from Monday to Friday for 6.5 weeks. It is combined with chemotherapy that includes mitomycin during the first and fifth weeks of radiation therapy, as well as capecitabine that are taken on the days of radiation therapy.In the experimental arm, this chemoradiotherapy treatment is preceded by 4 sessions of mDCF chemotherapy performed every 2 weeks.After treatment, patients are followed up at 8 weeks, then every 4 months for 2 years, and every 6 months for the last year with clinical examination and imaging (CT and MRI).
CONDITIONS
Official Title
Phase III Study Evaluating Induction Chemotherapy Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced SCCA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed anal squamous cell carcinoma
- Locally advanced tumors without metastases (Stage T3 or T4, or Stage N1 any T)
- Age 18 to 75 years or over 75 with a favorable oncogeriatric assessment (G8 score > 14)
- Measurable tumor on MRI
- Ability to receive chemotherapy and radiotherapy
- No major comorbidity preventing treatment delivery
- Adequate blood counts: neutrophils ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥9 g/dl
- Adequate kidney function: creatinine clearance ≥60 ml/min
- Adequate liver function: AST and ALT ≤2.5 times upper normal limit, total bilirubin ≤1.5 times upper normal limit
- WHO performance status less than 2
- Signed informed consent
- Negative pregnancy test for women of childbearing potential
- Women postmenopausal for at least one year or surgically infertile for at least 6 weeks, or effective contraception for males and females of childbearing potential during and after treatment
- Covered by French Social Security system
You will not qualify if you...
- Presence of metastases
- Stage T1N0 or T2N0 tumors
- Previous pelvic radiotherapy
- Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency
- HIV positive with CD4 count less than 400/mm3
- Neuropathy greater than grade 2
- Contraindication to chemotherapy or radiotherapy
- Concurrent treatment with CYP3A4 inhibitors or inducers
- Symptomatic cardiac or coronary insufficiency
- Active progressive infection or severe condition within last 6 months
- Contraindication to MRI
- Other cancers treated in last 3 years except certain in situ carcinomas
- Breastfeeding women
- Persons deprived of liberty, under guardianship, or unable to consent
- Psychological, familial, social, or geographical conditions that may affect study compliance
- Live attenuated vaccines within 4 weeks before randomization
- Hearing problems
- Use of phenytoin for prophylaxis
- Recent or concurrent brivudine treatment
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 114 locations
1
AGEN-Cromg
Agen, France
Not Yet Recruiting
2
Clinique Calabet
Agen, France
Not Yet Recruiting
3
AIX EN PROVENCE CH Pays d'Aix
Aix-en-Provence, France
Not Yet Recruiting
4
Amiens - Clinique de L'Europe
Amiens, France
Not Yet Recruiting
5
ANTONY Hôpital Privé
Antony, France
Not Yet Recruiting
6
Argenteuil - Ch
Argenteuil, France
Actively Recruiting
7
ARRAS Les Bonnettes
Arras, France
Not Yet Recruiting
8
ARRAS Marie Curie
Arras, France
Not Yet Recruiting
9
AURILLAC-Henri Mondor
Aurillac, France
Not Yet Recruiting
10
Centre Medico Chirurgical
Aurillac, France
Not Yet Recruiting
11
AUXERRE CH GHT Unyon
Auxerre, France
Actively Recruiting
12
Avignon Icap
Avignon, France
Actively Recruiting
13
Avranches - Hopital Prive de La Baie
Avranches, France
Actively Recruiting
14
Bayonne- Clinique Belharra
Bayonne, France
Not Yet Recruiting
15
BEAUVAIS-Simone Veil
Beauvais, France
Not Yet Recruiting
16
Besancon Chu
Besançon, France
Actively Recruiting
17
Beuvry - Clinique Ambroise Pare
Beuvry, France
Not Yet Recruiting
18
Beuvry Pierre Curie
Beuvry, France
Not Yet Recruiting
19
Bordeaux - Privé - Tivoli
Bordeaux, France
Actively Recruiting
20
BORDEAUX-Institut Bergonié
Bordeaux, France
Actively Recruiting
21
Institut Bergonié
Bordeaux, France
Actively Recruiting
22
Pessac - Chu -Haut Leveque
Bordeaux, France
Actively Recruiting
23
Ch Duchenne
Boulogne-sur-Mer, France
Not Yet Recruiting
24
BREST Pasteur Lanroze
Brest, France
Actively Recruiting
25
CAEN Polyclinique du Parc
Caen, France
Actively Recruiting
26
CAEN-François Baclesse
Caen, France
Actively Recruiting
27
Cahors -Ch
Cahors, France
Not Yet Recruiting
28
Caluire Et Cuire-Infirmerie Protestante
Caluire-et-Cuire, France
Not Yet Recruiting
29
Chalon-Sur-Saone Hopital Sainte Marie
Chalon-sur-Saône, France
Actively Recruiting
30
Chambery Ch
Chambéry, France
Actively Recruiting
31
Chambray Les Tours-Roc37
Chambray-lès-Tours, France
Actively Recruiting
32
Centre Jean Perrin
Clermont-Ferrand, France
Not Yet Recruiting
33
Chu Estaing
Clermont-Ferrand, France
Not Yet Recruiting
34
Centre de Radiothérapie Savoie Nord
Contamine-sur-Arve, France
Not Yet Recruiting
35
Clinique de Flandre
Coudekerque-Branche, France
Not Yet Recruiting
36
CRETEIL-Henri Mondor CHU
Créteil, France
Actively Recruiting
37
DAX CH
Dax, France
Not Yet Recruiting
38
DECHY-Léonard de Vinci
Dechy, France
Actively Recruiting
39
Dijon - Chu François Mitterrand
Dijon, France
Actively Recruiting
40
DIJON-GF Leclerc
Dijon, France
Not Yet Recruiting
41
DIJON-Institut de Cancérologie de Bourgogne
Dijon, France
Actively Recruiting
42
Ghm Grenoble - Institut Daniel Hollard
Grenoble, France
Not Yet Recruiting
43
LA ROCHE-SUR-YON CHD Vendée
La Roche-sur-Yon, France
Actively Recruiting
44
Guillaume Le Conquérant
Le Havre, France
Not Yet Recruiting
45
LE HAVRE-l'Estuaire
Le Havre, France
Not Yet Recruiting
46
LE MANS-CH Victor Hugo
Le Mans, France
Actively Recruiting
47
Lille - Hopital Prive La Louviere
Lille, France
Not Yet Recruiting
48
Limoges - Polyclinique Francois Chenieux
Limoges, France
Not Yet Recruiting
49
Limoges-Chu Dupuytren
Limoges, France
Not Yet Recruiting
50
LONGJUMEAU-GHNE Hôpital d'Antony
Longjumeau, France
Not Yet Recruiting
51
Lorient - Groupe Hospitalier Bretagne Sud - Site Du Scorff
Lorient, France
Actively Recruiting
52
LYON Jean Mermoz
Lyon, France
Actively Recruiting
53
LYON- Léon Bérard
Lyon, France
Not Yet Recruiting
54
LYON-Saint Joseph
Lyon, France
Not Yet Recruiting
55
MARSEILLE Institut Paoli Calmettes
Marseille, France
Actively Recruiting
56
MARSEILLE Saint-Joseph
Marseille, France
Actively Recruiting
57
MARSEILLE-Hôpital la Timone
Marseille, France
Actively Recruiting
58
Montbeliard Ch
Montbéliard, France
Not Yet Recruiting
59
MONTPELLIER-ICM Val d'Aurelle
Montpellier, France
Actively Recruiting
60
Mougins Cac
Mougins, France
Actively Recruiting
61
MULHOUSE CH Emile Muller
Mulhouse, France
Actively Recruiting
62
Nantes - Hopital Prive Du Confluent
Nantes, France
Not Yet Recruiting
63
NEUILLY-SUR-SEINE GH Hartmann
Neuilly-sur-Seine, France
Not Yet Recruiting
64
NICE-Antoine LACASSAGNE
Nice, France
Actively Recruiting
65
Centre Hospitalier
Niort, France
Not Yet Recruiting
66
Nimes Chu
Nîmes, France
Not Yet Recruiting
67
ORLEANS Centre Hospitalier Régional
Orléans, France
Not Yet Recruiting
68
OSNY-CHP Sainte-Marie
Osny, France
Actively Recruiting
69
Paris - Ap-Hp - Hopital Tenon
Paris, France
Not Yet Recruiting
70
Paris - Chu -Saint Louis Aphp
Paris, France
Not Yet Recruiting
71
PARIS GHD Croix Saint-Simon
Paris, France
Actively Recruiting
72
PARIS Hopital Europeen Georges-Pompidou
Paris, France
Actively Recruiting
73
PARIS Institut Curie
Paris, France
Actively Recruiting
74
PARIS-Saint Joseph
Paris, France
Actively Recruiting
75
Pau Groupe de Radiotherapie Et D'Oncologie Des Pyrenees
Pau, France
Not Yet Recruiting
76
PERIGUEUX-Hôpital Francheville
Périgueux, France
Actively Recruiting
77
Plerin Hopital Prive Des Cotes D'Armor - Centre Cario
Plérin, France
Not Yet Recruiting
78
POITIERS- CHU la Miletrie
Poitiers, France
Actively Recruiting
79
PRINGY-Annecy Genevois CH
Pringy, France
Not Yet Recruiting
80
REIMS-CHU Robert Debré
Reims, France
Actively Recruiting
81
REIMS-Jean Godinot
Reims, France
Actively Recruiting
82
Rennes - Centre Eugene Marquis
Rennes, France
Not Yet Recruiting
83
Rennes Chu Pontchaillou
Rennes, France
Not Yet Recruiting
84
RODEZ CH
Rodez, France
Not Yet Recruiting
85
Hopitaux Prives Rouennais - Clinique Mathilde
Rouen, France
Not Yet Recruiting
86
ROUEN-Frédéric Joliot
Rouen, France
Actively Recruiting
87
Saint Denis Ch
Saint-Denis, France
Not Yet Recruiting
88
CHU
Saint-Etienne, France
Not Yet Recruiting
89
Saint Herblain Ico
Saint-Herblain, France
Actively Recruiting
90
SAINT NAZAIRE CM l'Estuaire
Saint-Nazaire, France
Not Yet Recruiting
91
Centre Hospitalier
Saint-Quentin, France
Not Yet Recruiting
92
SARCELLES - Institut de Cancérologie Paris Nord
Sarcelles, France
Not Yet Recruiting
93
Clinique Cote d'Emeraude
St-Malo, France
Not Yet Recruiting
94
Saint Malo Ch
St-Malo, France
Not Yet Recruiting
95
Strasbourg Icans
Strasbourg, France
Actively Recruiting
96
STRASBOURG Sainte Anne
Strasbourg, France
Actively Recruiting
97
Tarbes - Lourdes - Ch
Tarbes, France
Not Yet Recruiting
98
Tarbes - Polyclinique de L'Ormeau
Tarbes, France
Actively Recruiting
99
Thonon Les Bains - Hopitaux Du Leman
Thonon-les-Bains, France
Not Yet Recruiting
100
Centre de Radiothérapie Saint-Louis
Toulon, France
Not Yet Recruiting
101
TOULON-Sainte Anne
Toulon, France
Not Yet Recruiting
102
Toulouse - Oncopole Institut Claudius Regaud
Toulouse, France
Not Yet Recruiting
103
Toulouse Chu - Hopital Rangueil
Toulouse, France
Actively Recruiting
104
TOULOUSE-Clinique Pasteur
Toulouse, France
Actively Recruiting
105
TOURS CHU Trousseau
Tours, France
Actively Recruiting
106
Valence - Centre Marie Curie
Valence, France
Not Yet Recruiting
107
Valence Ch
Valence, France
Not Yet Recruiting
108
VALENCE Drôme-Ardèche
Valence, France
Not Yet Recruiting
109
Vandoeuvre Les Nancy-Ic Lorraine
Vandœuvre-lès-Nancy, France
Actively Recruiting
110
VILLEJUIF Gustave Roussy
Villejuif, France
Actively Recruiting
111
Centre de Radiothérapie Bayard
Villeurbanne, France
Not Yet Recruiting
112
Villeurbanne Medipole Hopital Mutualiste Lyon
Villeurbanne, France
Not Yet Recruiting
113
Reunion - Chu Sud
Saint-Pierre, Reunion
Not Yet Recruiting
114
La Reunion - Clinique Prive Sainte Clotilde
Sainte-Clotilde, Reunion
Not Yet Recruiting
Research Team
V
Veronique Vendrely, Md-pHD
CONTACT
J
Jérémie BEZ, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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